LumiraDx
OTCPK:LMDX.F
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End-of-day quote: 07/27/2024
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LumiraDx Company Info
EPS Growth 5Y
0,00%
Market Cap
£0,00 B
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£0,00
Dividend Yield
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In the last five quarters, LumiraDx’s Price Target has risen from £0,65 to £0,65 - a 0,00% increase.
Top growth stocks in the health care sector (5Y.)
What does LumiraDx do?
LumiraDx Limited (LumiraDx) operates as a next-generation point-of-care (POC) diagnostic company. The company is addressing the limitations of legacy POC systems by bringing lab-comparable performance to the POC in minutes, with a broad menu of tests that can be performed on a single instrument.
The company's Platform is an integrated system consists of a small, versatile Instrument; precise, actively controlled microfluidic test strips; and seamless, secure digital connectivity. The company ha...
LumiraDx Limited (LumiraDx) operates as a next-generation point-of-care (POC) diagnostic company. The company is addressing the limitations of legacy POC systems by bringing lab-comparable performance to the POC in minutes, with a broad menu of tests that can be performed on a single instrument.
The company's Platform is an integrated system consists of a small, versatile Instrument; precise, actively controlled microfluidic test strips; and seamless, secure digital connectivity. The company has 12 diagnostic tests that have received regulatory approval, authorization, certification or clearance for use on its Platform and a broad menu of tests in its long-term development plan.
The company's Platform is designed to simplify, scale-down, and integrate multiple testing methodologies onto a single instrument and offer a broad menu of tests with lab-comparable performance and with results generally in 12 minutes or less from sample to result. The company's focus is on transforming community-based healthcare by providing critical diagnostic information to healthcare providers at the point of need, enabling informed medical decisions to improve health outcomes while lowering costs.
The company's actively controlled microfluidic technology and Platform have been proven to meet the market needs for fast, high-sensitivity, convenient and connected diagnostic test results - for health systems, emergency rooms, retail pharmacy chains and other community settings. As of December 31, 2022, the company had equipment capacity to manufacture over 28 million test strips a month for its Platform and it has deployed approximately 28,000 Instruments across over 100 countries.
The company is initially focused on the development of tests for several of the most common conditions diagnosed or managed in community-based healthcare settings. For many of the tests the company commercializes, or plans to commercialize, there are no existing POC alternatives which provide highly accurate results in a short period of time at the POC. The company's initial authorized and CE Marked tests and those under development are designed to address unmet diagnostic needs in the fields of infectious disease, cardiovascular disease, diabetes, and coagulation disorders.
The company's test menu includes its INR test for monitoring warfarin therapy, its HbA1c test for monitoring diabetes, its NT-proBNP test for aiding in the diagnosis of heart failure, its D-Dimer test for aiding in diagnosis and exclusion of venous thromboembolism, and its CRP test which measures a universal biomarker of infection and inflammation, all of which are CE Marked. In addition, the company has obtained various approvals for the sale and distribution of several of these tests in a wide variety of countries across the globe and has provided its products to over 100 countries worldwide. Each of these tests deliver lab comparable performance from a fingerprick of blood in 12 minutes or less. This menu of tests, together with the respiratory portfolio described below, covers a majority of the most commonly used assays in primary care settings and pharmacies across the European Economic Area (EEA) and the United Kingdom. For the company's customers, this enables the consolidation of multiple instruments to a single connected Platform and workflow.
In addition, the company has CE Marked its SARS-CoV-2 antigen pool test, its SARS-CoV-2 & Flu A/B test, its SARS-CoV-2 & RSV test and its SARS CoV-2 Ag Ultra and Ultra Pool tests. The company's SARS-CoV-2 Ag Ultra test matches the same high performance as its SARS-CoV-2 antigen test with results at the POC in five minutes. The company considers speed and accuracy of test results to be at the core of LumiraDx's transformative potential and represent competitive advantages in POC diagnostics. The launch of the company's additional respiratory assays, such as Flu A/B and RSV, outside of COVID-19, allows it to meet the growing demand for POC diagnostics in primary care across the EEA and the United Kingdom as it moves to a post-pandemic world where traditional respiratory viruses will co-circulate with COVID-19 and rapid testing and differentiation will be desired. The company is actively redeploying this footprint for broader testing capabilities in the community, to address high unmet needs in diabetes, cardiovascular, infectious disease and coagulation.
The company's proprietary microfluidic test strip is designed to accommodate all of its assays and sample types for use on its Instrument in a single-design architecture. The company can manufacture its test strips at large scale and low cost on its proprietary manufacturing system. The company has 50+ tests in its long-term strategic roadmap for community-based healthcare settings and plan to launch additional tests, subject to successful development and regulatory approval, authorization, certification or clearance. The company's key tests under development are high-sensitivity Troponin I for cardiovascular disease and Strep A molecular, both which have provided promising performance data.
The company has direct sales and marketing operations in 21 countries, including the United States, most Western European countries, Japan, Colombia, Brazil, India and South Africa. While these direct sales operations are likely to be impacted by the company's recently announced cost reduction programs, its long-term strategic plan includes expansion into the largest IVD markets, including China and Southeast Asia. The company sells mainly to large healthcare systems, government organizations and national pharmacy chains that can deploy comprehensive POC testing across their extensive healthcare provider networks.
The company has also used its technology to develop four rapid COVID-19 molecular reagent testing kits for use on open molecular systems, SARS-CoV-2 RNA STAR, SARS-CoV-2 RNA STAR Complete, SARS-CoV-2 & Flu A/B RNA STAR Complete and Dual-Target SARS CoV-2 STAR Complete. SARS-CoV-2 RNA STAR allows laboratories to utilize their existing molecular lab infrastructure in a high-throughput format by reducing amplification time from approximately one hour down to 20 minutes. SARS-CoV-2 RNA STAR Complete utilizes a direct amplification method that combines lysis and amplification in a single step, detecting SARS-CoV-2 nucleic acid in under 20 minutes, without needing to perform any specimen purification or extraction. All of these products have been CE Marked and the company has obtained EUAs for SARS-CoV-2 RNA STAR, SARS-CoV-2 RNA STAR Complete and SARS-CoV-2 & Flu A/B RNA STAR Complete. Beyond the lab, this technology has significant implications for the company's forthcoming POC molecular programs.
Solution
The company has developed and launched its Platform with the aim of transforming the delivery of healthcare in community-based healthcare settings. It is designed to deliver accurate results comparable to laboratory reference assays, in an easy-to-use POC solution in minutes. The company's Platform consists of a small, light-weight Instrument that is mainly battery operated and capable of going anywhere the patient is located; precise, actively controlled microfluidic test strips, which share common design features allowing various test strip assay types to be operated, controlled and measured by the Instrument; and seamless, secure digital connectivity.
The company has spent years developing its Platform and have designed and optimized its Instrument and test strip together to deliver the requisite lab-comparable quality results, where lab references are available, across the full range of assay and sample types with results generally in 12 minutes or less. The company's Instrument has been highly engineered with many innovations which enable actively controlled precise fluidic control of samples in very low volumes and high sensitivity fluorescent detection of analytes in very low concentration. The company's proprietary microfluidic test strip has been designed to be integrated with its Instrument, to perform the specific and precise microfluidic sequence for the assays. The company's test strip has been designed with multiple channels, enabling the Instrument to perform either multiple tests or a panel in parallel (e.g., Flu A/B + SARS-CoV-2 antigen), or utilize multiple channels on a single test strip for analytes with the most demanding performance requirements (e.g., SARS-CoV-2 antigen).
Strategy
The key elements of the company's strategy are to offer a comprehensive menu of high-performance diagnostic tests for community-based healthcare settings; grow its installed base by executing an institutional sales and channel partnership model; expand into additional healthcare settings and underserved markets; continue to innovate to expand into specialty areas; and continue to innovate across its platform.
Products
Instrument
The company's Instrument runs a variety of diagnostic testing technologies utilizing its disposable test strips and generates results that are clearly displayed on the Instrument touchscreen generally in under 12 minutes. The company's Instrument is designed for use with its approved and future tests, which all share a common design and have been developed for use with very low sample volumes. The company's Instrument, in connection with the test strips, is capable of very sensitive measurements at very low levels of concentration. The ability to make measurements at low levels of detection (LOD), is highly beneficial and directly impacts efforts to identify and detect disease, including, for example, COVID-19.
Diagnostic Tests
As of December 31, 2022, the company had 12 diagnostic tests for which it has obtained regulatory approval, authorization, certification or clearance under EUA and/or CE Mark for use with its Instrument.
The company's Platform is the only platform that can run both an INR and D-Dimer test on the same platform (each comprising a different technology - enzyme vs. immunoassay). It is the only platform that can run D-Dimer and NT-proBNP from a direct fingerstick sample.
SARS-CoV-2 Antigen Test
The company's SARS-CoV-2 antigen test has been developed to detect the SARS-CoV-2 virus in respiratory samples, such as nasal and nasopharyngeal swabs with results at the POC in 12 minutes or less.
Unlike lateral flow tests which use old technology developed for at-home pregnancy testing, the company's SARS-CoV-2 antigen test is a next-generation test system using microfluidic immunofluorescence technology to detect tiny amounts of the virus antigen in just a few microliters of nasal swab extract. The company's high sensitivity LumiraDx SARS-CoV-2 antigen test has the opportunity to take a significant share of the POC COVID-19 molecular and lateral flow testing market.
The performance of the company's test is attributable to its design, as well as the actively controlled precise microfluidic control of its Instrument. The company's test uses SARS-CoV/SARS-CoV-2 specific antibodies in an immunoassay to determine the presence of SARS-CoV-2 nucleocapsid protein (NP) present in the test sample. The company's Instrument generally uses multiple independent assay channels in the test strip to detect the NP antigen in the test sample. It directs fluidic movement and mixing of the reagents and test sample in each test strip channel. A magnetic field is then applied to the measurement zone which retains the magnetic particles and associated SARS-CoV-2 NP immuno-complexes allowing removal of the sample and any unbound label from the measurement zone. The company's Instrument measures the fluorescent signal of the immuno-complex fluorescent particles in an essentially dry state which is proportional to the concentration of the SARS-CoV-2 virus NP antigen in the sample. The strip contains on-board control reagents that are used to verify that the test operated correctly. The company's SARS-CoV-2 antigen test detects major global SARS-CoV-2 variants, including Delta, Gamma, Epsilon, Alpha, Beta and Omicron variants. The company is continually testing the new variants of clinical concern as they arise to confirm the performance of its SARS-CoV-2 antigen test.
The company obtained an emergency use authorization (EUA) for its SARS-CoV-2 antigen test and CE Marked this product. Its SARS-CoV-2 antigen test has been authorized by the FDA under an EUA only for the qualitative detection of SARS-CoV-2 nucleocapsid protein and has not been authorized for use to detect any other viruses or pathogens. In line with similar requests that the FDA has made to other antigen test providers, the U.S. Food and Drug Administration (FDA) recently requested that the company updates the product labeling on its SARS-CoV-2 antigen test to provide a serial testing requirement for asymptomatic individuals and recommend testing twice over three days with at least 24 hours (and no more than 48 hours) between tests for such asymptomatic individuals. In addition, the company's SARS-CoV-2 antigen test is available pursuant to an EUL by the World Health Organization (WHO). The CE Mark was affixed pursuant to a self-certification process in accordance with E.U. regulatory requirements. The company has also received various external validations of its SARS-CoV-2 antigen test, including from the Swiss and Japanese governments, and the Scandinavian evaluation of laboratory equipment for POC testing (SKUP), which show the performance of its SARS-CoV-2 antigen test. This test was also successfully validated by the U.K. Health Security Agency (UKHSA) under the CTDA.
The company has established a proactive system and plans to monitor and evaluate the impact of mutations and viral variants on the performance of its test. The company's SARS-CoV-2 antigen test detects major global SARS-CoV-2 variants, including Delta, Gamma, Epsilon, Alpha, Beta, Omicron and XBB.1.5 variants.
SARS-CoV-2 Antibody Test
The company's SARS-CoV-2 antibody test has been developed to detect the presence of SARS-CoV-2 total antibody in a blood sample with performance at the POC and delivers the results in 11 minutes.
Antibody testing is used to understand the virus's epidemiology in the general population and identify groups at higher risk of infection. In addition, serologic testing can be offered as a method to support diagnosis of acute COVID-19 illness for persons who present late and potentially over time to measure immunity.
The company's SARS-CoV-2 antibody test has been developed to detect presence of SARS-CoV-2 total antibody in a blood or plasma sample with high sensitivity and specificity from onset of symptom through disease progression. Its test uses SARS-CoV-2 Spike (S1) and Receptor Binding Domain (RBD) antigens in an immunoassay to determine the presence of SARS-CoV-2 antibodies in the test sample. The company's Instrument generally uses multiple independent assay channels in the test strip to detect the antibodies in the test sample. It directs fluidic movement and mixing of the reagents and test sample in each test strip channel. A magnetic field is then applied to the measurement zone which retains the magnetic particles and associated SARS-CoV-2 antibody immuno-complexes allowing removal of the sample and any unbound label from the measurement zone. The company's Instrument measures the fluorescent signal of the immuno-complex fluorescent particles in an essentially dry state which is proportional to the concentration of the SARS-CoV-2 antibody in the sample. The strip contains on-board control reagents that are used to verify that the test operated correctly. In clinical studies, the company's SARS-CoV-2 antibody test has demonstrated high sensitivity and high specificity across the COVID-19 diagnostic window.
The company has obtained an EUA for its SARS-CoV-2 antibody test and CE Marked this product. The CE Mark was obtained pursuant to a self-certification process in accordance with E.U. regulatory requirements.
SARS-CoV-2 Antigen Pool Test
Pooled testing enables higher test throughput and lower cost per individual which is important for mass testing at schools, workplaces and events.
Pooled testing is generally performed on RT-PCR systems with multiple samples combined into a single reaction to increase the number of samples processed per batch. Follow up testing is done with remnant samples in the lab or by follow up using a rapid test.
The SARS-CoV-2 antigen pool test is intended for qualitative detection of nucleocapsid protein antigen SARS-CoV-2 in one to five individual samples from professionally supervised and self-collected nasal swab samples or professionally collected nasal or nasopharyngeal swab samples which are then pooled for testing. In clinical studies, the SARS-CoV-2 antigen pool test demonstrated 100% PPA and 96.6% NPA to the individual SARS-CoV-2 antigen test.
The company has affixed the CE Mark to its SARS-CoV-2 antigen pool test. The CE Mark was affixed following a self-certification process in accordance with E.U. regulatory requirements. It is the first and only POC antigen pool test commercially available in the EEA.
SARS-CoV-2 & Flu A/B Test
The company's SARS-CoV-2 & Flu A/B test was successfully validated by the UKHSA under the CTDA process and it has affixed the CE Mark in the EEA, pursuant to a self-certification process in accordance with E.U. regulatory requirements, and from the PMDA in Japan. In the United States, the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) Tech program has established the Independent Test Assessment Program (ITAP) in order to accelerate regulatory review and availability of high-quality, accurate, and reliable diagnostic tests. The company is working with ITAP to submit an EUA for its SARS-CoV-2 & Flu A/B test. The company intends to submit 510K application in H1 2024.
In clinical studies, the company's SARS-CoV-2 & Flu A/B test demonstrated up to 95.5%, 83.3% and 80.0% PPA versus RT-PCR for detection of SARS-CoV-2, Flu A and Flu B, respectively.
SARS-CoV-2 & RSV Test
The company has affixed the CE Mark to its SARS-CoV-2 & RSV test in the EEA, pursuant to a self-certification process in accordance with E.U. regulatory requirements, and, depending on test demand, the company plans to proceed with a 510K submission to the FDA in H1 2024.
The launch of the company's additional respiratory assays, such as RSV, outside COVID-19 allows it to meet the growing demand for POC diagnostics in primary care across the EEA and the United Kingdom as it moves to a post-pandemic world where traditional respiratory viruses will co-circulate with COVID-19 and rapid testing and differentiation will be desired.
SARS-CoV-2 Ag Ultra
The SARS-CoV-2 Ag Ultra test detects SARS-CoV-2 virus in respiratory samples, such as nasal swabs with results at the POC in five minutes. The company has affixed the CE Mark to its SARS-CoV-2 Ag Ultra test in the EEA, pursuant to a self-certification process in accordance with E.U. regulatory requirements. The company submitted an amendment to its SARS-CoV-2 Ag EUA to cover this innovative Ultra component in February 2023 and plan for 510(k) submission in H1 2023.
In clinical studies, the company's SARS-CoV-2 Ag Ultra test demonstrated a PPA of 98.6% at Ct<33 and 96.0% at Ct<35 indicating high coverage of potentially infectious individuals.
The company's continued planned development of its Ultra tests as a product line provides the opportunity to move the entire respiratory market towards fast and high sensitivity antigen testing, including Flu A/B and RSV.
SARS-CoV-2 Ag Ultra Pool
The SARS-CoV-2 Ag Ultra Pool test is intended for qualitative detection of nucleocapsid protein antigen of SARS-CoV-2 in one to five individual samples which are pooled for testing to detect the SARS-CoV-2 virus, with results in five minutes. The company has affixed the CE Mark to its SARS-CoV-2 Ag Ultra Pool test in the EEA, pursuant to a self-certification process in accordance with E.U. regulatory requirements.
International Normalized Ratio (INR) Test
INR is a standardized measurement of the rate at which blood clots. The company's INR test has been validated in various clinical studies against reference lab standard ACL ELITE Pro. One study, the OPTIMAL study, conducted in 11 sites by Glasgow Royal Infirmary, Queen Elizabeth Hospital and Golden Jubilee Hospitals and NHS anti-coagulation services, showed strong correlation between its Platform and laboratory reference method, as well as between the different application methods and test lots. Another study confirmed strong correlation between the company's INR test results (capillary blood sample) and those obtained from plasma samples using both the ACL Elite and also the Sysmex CS 2100/5100. Feedback from healthcare professionals indicated that the company's Platform was easy to follow and use. Data overall demonstrated that the company's INR test provided rapid and reliable INR analysis at the POC.
The company has affixed the CE Mark to its INR test, pursuant to a self-certification process in accordance with E.U. regulatory requirements, and it plans to submit a 510(k) to the FDA in H2 2023.
D-Dimer Test
D-Dimer is a fibrin degradation product, a small protein fragment present in the blood after a blood clot is degraded by fibrinolysis. Until the launch of the LumiraDx D-Dimer test, there were no quantitative POC tests for D-Dimer using a direct fingerstick sample.
The company's D-Dimer test delivers quantitative results in six minutes from a fingerstick blood sample. It is the only quantitative D-Dimer test available on the market with direct fingerstick sampling capabilities. The test is aimed to be used as an aid in the assessment and diagnosis of patients with suspected venous thromboembolism (VTE), such as deep vein thrombosis (DVT) and pulmonary embolism (PE). It is designed to be used by healthcare providers or other trained professionals in community-based healthcare or urgent care/hospital ED settings.
During H1 2022, the company expanded its CE Mark to include a clinical cut-off. This will allow the company to include an 'exclusion' claim, used by healthcare professionals to exclude VTE as a potential diagnosis for patients experiencing symptoms of VTE, in conjunction with additional clinical risk scores. The CE Marked exclusion claim was supported by the company's on-going prospective study in the United Kingdom and Germany, EMBOL, to support use in ruling out VTE. Interim analysis based on 618 symptomatic patients presenting in emergency department and ambulatory clinic settings, demonstrated that the LumiraDx D-Dimer test has strong correlation with the laboratory reference method and also has 100% negative predictive value at the 500 ug/L cut off, when used in combination with a pretest probability score. To the company's knowledge, this is the first study to prospectively demonstrate the use of a quantitative fingerstick D-Dimer test at POC to rule out VTE in symptomatic patients, which has the opportunity to significantly improve primary care assessment by physicians of DVT, and also potentially reduce the time of the patient's hospital visit, as well as follow up testing and scans. The POC D-Dimer test has potential opportunity to improve the clinical, operational and cost outcomes for the VTE pathway.
In addition, D-Dimer testing is expected to have a utility as part of diagnosis and management of COVID-19 infected patients as D-Dimer has also been shown to be a prognostic indicator for predicting severity of symptoms in patients with COVID-19 infection.
The company has affixed the CE Mark to its D-Dimer test, pursuant to a self-certification process in accordance with E.U. regulatory requirements, and the company plans to submit a 510(k) to the FDA in H1 2024.
C-Reactive Protein (CRP) Test
The LumiraDx CRP test was CE Marked in January 2022, pursuant to a self-certification process in accordance with E.U. regulatory requirements, and has since been introduced into the EEA, the Middle East and Africa. The company plans to continue to expand its global footprint by completing registrations in other key markets, including South America and Asia.
For its CRP test in the EEA, in May 2022, the company expanded the intended use to include testing in children over the age of two. Offering this test on the same Platform as COVID, Flu A/B and RSV aids physicians to quickly and accurately diagnose, as well as treat respiratory conditions in children at the POC.
The company's portfolio of rapid CRP and pathogen specific assays on one Platform offers a strong antimicrobial stewardship toolkit for primary care where the focus on reducing unnecessary antimicrobial prescribing is growing. For example, studies have shown that at least 20% of antibiotics prescribed in primary care in England are inappropriate. The company's Platform is well-positioned to enable rapid testing to aid physicians in assessment of their treatment decisions and reduce unnecessary prescribing in both adults and children.
Glycated Hemoglobin (HbA1c) Test
The company's HbA1c test is for use by healthcare professionals in POC settings for the quantitative determination of glycated hemoglobin in human capillary and venous blood samples in less than seven minutes. This test is to be used as an aid in the monitoring of long-term glycemic control in individuals with diabetes mellitus, and as an aid in screening and identifying patients who may be at risk for developing diabetes. Additionally, HbA1c monitoring at POC enables improved patient physician management of diabetes and comorbidities.
The company has affixed the CE Mark to its HbA1c test, pursuant to a self-certification process in accordance with E.U. regulatory requirements, and it plans to submit a 510(k) to the FDA in H2 2023. The LumiraDx HbA1c test is IFCC and NGSP certified.
The company considers HbA1c to be a large and high growth test in the POC market, and the company is already seeing the potential impact of this addition with some of its customers. For example, Boots Pharmacy has a 200 plus install base used for COVID testing for which they are starting to offer Hb1Ac due to the rising number of patients with diabetes.
With the addition of HbA1c to the test menu, the company will offer on the LumiraDx Platform many of the most commonly used assays at POC in primary care settings and pharmacies across the EEA and the United Kingdom. For the company's customers it will enable the consolidation of multiple instruments to a single connected Platform and workflow. It continues to invest in workflow improvements for this test.
The LumiraDx HbA1c test was recently evaluated (February 2023) at the European Reference Laboratory for Glycohaemoglobin (ERL). The aim of the evaluation was to assess the performance of fresh EDTA whole blood samples compared to values assigned using four IFCC and NGSP certified Secondary Reference Measurement Procedures (SRMPs).
Natriuretic Peptides
The LumiraDx NT-proBNP test provides quantitative measurement of NT-proBNP from a direct fingerstick sample with results in 12 minutes. It is intended to be used as an aid for diagnosing heart failure. The LumiraDx NT-proBNP test is a highly portable solution designed to improve access to NT-proBNP testing in community-based healthcare settings. The direct fingerstick sample type removes the need for phlebotomy, thereby significantly opening up the settings where NT-proBNP testing can be carried out. This will help improve access to early diagnosis for heart failure.
The company has affixed the CE Mark to its NT-proBNP test, pursuant to a self-certification process in accordance with the E.U. regulatory requirements of the in vitro diagnostic medical devices (IVDD), and it plans to submit a 510(k) to the FDA in H1 2024.
Product Roadmap
The company has 50+ tests in its long-term strategic roadmap for community-based healthcare settings and plans to launch additional tests, subject to successful development and regulatory approval, authorization, certification or clearance. The company's key tests under development are high-sensitivity Troponin I for cardiovascular disease and Strep A molecular, both which have provided promising performance data. The company will focus on the most attractive markets initially.
High Sensitivity Troponin I (hs-TnI) Test
The company is developing a highly sensitive Troponin POC test, which is aimed to provide a paradigm shift in suspected MI patients care management and can measure Troponin at very low levels allowing for clinical decisions to be made directly at the POC, in the hospital emergency room or physician office, and ensuring that healthcare providers can rely on the results of this test, and other clinical guidance, to establish if the patient is having a MI or over time can be ruled out and re-directed for further testing in other areas where required.
In addition, it is envisaged that the portability and connectivity of the company's Platform will, over time, allow suspected MI patient diagnosis, provided for example by paramedics in emergency situations, at the patient's home or in the ambulance. The company has already demonstrated that it can measure at very low concentration and LOD in its SARS-CoV-2 assays.
The company's high sensitivity Troponin test is in the development phase. It plans to submit for in vitro diagnostic medical devices Regulation 2017/746 (IVDR) and 510K review in mid 2024, with potential for faster access to strategic markets, such as the U.K.
Strep A
The company is developing a molecular Strep A test which is aimed at achieving high sensitivity results in minutes, without the need for culture confirmation leading to fast and accurate test and treatment of potential Strep A infections. The test will be manufactured on the company's standard manufacturing equipment with all the low-cost benefits offered.
The company's molecular Strep A test is in the feasibility phase and it plans to complete the design and development process to submit a 510(k) to the FDA in H1 2024.
Tuberculosis (TB)
The company is developing a first in class POC molecular test for TB using a tongue swab. This test has the ability to dramatically increase testing access to high quality molecular TB testing in the world's highest burden countries, as well as the developed world where TB testing is important for immigration, border patrol, incarcerated individuals, and other key populations.
The company's TB test utilizes a tongue swab sample, which makes collection easier than the standard sputum sample. With a turnaround time of less than 15 minutes, the company's test allows a patient to immediately initiate treatment if they test positive rather than the current model, which requires a sample be sent off to a central lab. Additionally, the company's testing platform is portable, rugged, and has a battery backup so it can be used in decentralized settings where the majority of patients with suspected TB present for care.
The company's TB test is in the development phase and being implemented in multiple pre-clinical studies in Africa. The company anticipates completing development of the assay and entering its clinical trial by the end of 2023 so that it can submit to the WHO and the FDA in 2024.
HIV Viral Load
The company's HIV viral load test is in the feasibility phase.
Procalcitonin (PCT)
The company's PCT test is in the development phase.
Sodium, Potassium (Na, K)
The company's Na/K test is in the feasibility phase.
Lipids
The company's lipid panel is in the concept phase.
Molecular Tests
The company has developed over the last few years a proprietary molecular chemistry, qSTAR (Selective Temperature Amplification Reaction), which forms the basis of its molecular assays. This new technology is a non-PCR enzyme-based system with an optimized temperature profile that is suitable to deliver very sensitive, rapid near patient results.
The company's molecular tests, which incorporate its proprietary qSTAR technology, are designed to offer many competitive advantages in the market, including minimal user steps and reduced sample preparation steps and time. The company's molecular tests leverage the same strip design as its other tests, and have the ability to run on its Instrument with results expected in approximately 10-15 minutes. The company's molecular test strips are manufactured on the same automated manufacturing system as its other test strip designs, using the same base materials.
The company has already shown feasibility on a wide range of tests using this molecular technology with its Platform. The company is working on various molecular tests with a focus on infectious diseases, such as HIV and tuberculosis, both of which are being supported by BMGF, and Strep A molecular. The company's molecular TB test is designed to be a true POC diagnostic test that is safe and easy to use in remote care settings, with high sensitivity results in minutes. The company's molecular Strep A test is designed to enable it to offer a comprehensive portfolio of common respiratory conditions, with the clinical benefits offered by high sensitivity Strep A testing. The company's molecular pipeline includes additional tests in sexual health and virology. Upon regulatory approval, authorization, certification or clearance and launch of its molecular tests, it would be the only company providing molecular and non-molecular technologies on the same Instrument.
The development of this proprietary technology is being strengthened and enhanced by the research and development efforts of the company's Fast Lab Solutions team. qSTAR technology is highly applicable to diagnostic testing for COVID-19. Detecting virus via RNA or antigen is the standard of care for COVID-19 diagnosis. But molecular diagnostic testing in the lab is a time consuming and complex process. LumiraDx applied its qSTAR technology to the development of rapid molecular COVID-19 reagent testing kits for use on open molecular systems. The technology allows for the reduction of amplification timing which increases throughput over other molecular platforms, while maintaining the sensitivity of detection.
qSTAR technology can amplify highly conserved regions of the SARS-CoV-2 genome that are smaller in size than other molecular technologies, such as a reverse transcription-polymerase chain reaction test (RT-PCR). This reduces or eliminates the risk of mutation occurring in the region selected for detection. Therefore, as of December 31, 2022, the assay detected all major global SARS-CoV-2 variants, including Omicron, Omicron B.2, Delta, Gamma, Epsilon, Alpha, and Beta variants.
Fast Lab Solutions
The company's Fast Lab Solutions products support high-complexity laboratory testing within brick-and-mortar core laboratories, semi-temporary testing pods, mobile laboratories, and remote self-collection services. The Fast Lab Network improves access to diagnostic testing through strategic placement of laboratories across the United States that can respond to the ever-changing needs of infectious disease testing with scalable capacity and rapid turnaround times. The goal of this network is to deliver laboratory quality results within 24 hours anywhere and provide rapid response to COVID-19 flare-ups/hotspots. In addition, this network was developed to provide immediate infrastructure when needed to respond to COVID-19 variants, along with potential future outbreaks and pandemics.
The company has multiple COVID-19 molecular reagent kits commercially available:
SARS-CoV-2 RNA STAR has received an EUA from the FDA. The assay allows laboratories to utilize their existing molecular lab infrastructure in a high-throughput format by reducing amplification time from approximately one hour down to 12 minutes.
SARS-CoV-2 RNA STAR Complete has received an EUA from the FDA, was CE Marked, pursuant to a self-certification process in accordance with E.U. regulatory requirements, and was successfully validated by the UKHSA under the coronavirus test device approval (CTDA) process. The assay utilizes a direct amplification method that combines lysis and amplification in a single step, detecting SARS-CoV-2 nucleic acid in under 20 minutes, without needing to perform any specimen purification or extraction. SARS-CoV-2 RNA STAR Complete provides approximately a two- to four-fold increase of testing throughput over common open molecular systems, allowing laboratories to improve turnaround time of patient results and expand their testing capacity with existing instrumentation. In December 2021, the company achieved several FDA EUA updates for RNA STAR Complete molecular reagents, including asymptomatic testing, pooling of up to five individuals, and access to 384 well configuration on validated open RT-PCR systems. In addition, through expanded authorization with HealthPulse@Home, the company is able to offer sample collection at home and elsewhere, increasing access to molecular testing. In February 2022, the company also achieved the Medicines and Healthcare Products Regulatory Agency (MHRA) authorization for RNA STAR Complete, enabling it to fulfill customer demand in the United Kingdom for high throughput, high sensitivity and high efficiency testing at events, schools, airports, and other public venues.
SARS-CoV-2 & Flu A/B RNA STAR Complete received an EUA from the FDA, was CE Marked pursuant to a self-certification process in accordance with E.U. regulatory requirements, and was successfully validated by the UKHSA under the CTDA process. This test has an FDA agreed-upon post-authorization clinical evaluation study which, upon completion, will require an update to the labeling to reflect the additional testing.
Dual-Target SARS CoV-2 STAR Complete has been CE Marked pursuant to a self-certification process in accordance with E.U. regulatory requirements and was successfully validated by the UKHSA under the CTDA process. This new molecular lab reagent kit adds the ability to test for two distinct COVID-19 virus genes to the company's Fast Lab Solutions product line.
Market Segments
LumiraDx has a customer focused growth strategy with product roadmaps and partnerships in three key market segments that provide community-based care.
Physician Office/ Retail/ Pharmacy
The physician office, retail, pharmacy market segment is focused on individuals seeking primary care, wellness, urgent care, as well as chronic disease management. It is a rapidly growing segment with individuals looking for faster and more convenient ways to receive their healthcare. The company's three-year product roadmap in this segment includes tests for infectious disease, diabetes, cardiovascular disease, coagulation, and sexual health.
Acute/ Emergency Care
The acute and emergency care market is focused on individuals seeking urgent care for severe and potentially life-threatening conditions. The company's three-year product roadmap in this segment includes tests for cardiac disease, metabolites, infectious disease, and hospital acquired infections.
Global Health
The global health market segment encompasses testing for TB, HIV, malaria and maternal and childhood care in developing countries, particularly those in sub-Saharan Africa. LumiraDx has worked with The Bill & Melinda Gates Foundation to provide more than 5,000 platforms across Africa. The company's three-year product roadmap in this segment includes tests for TB, HIV, malaria, and maternal and childhood care.
Research and Development
For the year ended December 31, 2022, the company's research and development expenses were $141.6 million.
Manufacturing
The company's Instrument is manufactured by a contract manufacturer, Flextronics Ltd., at its facility in Althofen, Austria with components and assemblies supplied by Flextronics and by outside vendors.
Sales and Marketing
As of December 31, 2022, the company had 254 employees focused on sales and marketing located in more than 30 countries. The company has direct sales operations in the United States, most Western European countries, Japan, India, South Africa, Colombia and Brazil. The organization consists primarily of individuals with multiple years of experience in diagnostics, specifically POC testing, with large diagnostic companies, such as Abbott Laboratories, Roche Holding AG and Danaher Corporation, and many others.
The company drives the penetration of its installed base by executing an institutional sales and channel partnership model. The company initially intend to focus its sales efforts on large healthcare systems, government organizations and national pharmacy chains that want to deploy comprehensive POC testing across their networks. The company has an experienced commercial team focused on leveraging key customers to deploy its Platform across multiple users with its training and support. To drive sales in additional healthcare settings, the company will identify key channel partners that are interested in standardizing around a POC testing platform to integrate care across their networks.
Over time, the company plans to operate with a direct sales and marketing presence in each of the largest diagnostic markets and to collaborate with distribution partners and medical wholesalers to ensure broad access to its Platform globally, for example in China and other countries in Southeast Asia. The company sells its Instruments or place them through reagent rentals.
Strategic Partners and Manufacturing and Supply Agreements
Bill & Melinda Gates Foundation (BMGF)
The company has collaborated with BMGF with the goal of achieving the following key objectives: developing assays with significant potential to improve global health, including a test for HIV viral load; accelerating development of LumiraDx's next-generation instrument that is robust and appropriate for all clinical settings, globally; and supporting local healthcare delivery partners in foundation-priority markets to incorporate the potential of LumiraDx technology into high-impact disruptive diagnostic treatment models.
CVS Exclusivity Agreement
On August 3, 2018, the company entered into an agreement with CVS Pharmacy Inc. (CVS) (the CVS Exclusivity Agreement), pursuant to which the company granted to CVS the exclusive right to purchase and use its Platform (or any components thereof, including the embedded software) in medical clinics located in retail stores and retail pharmacy businesses (the Exclusive Field) in the United States and its territories (the Territory).
NHS Arrangement
Since September 2020, the company had provided its POC SARS-CoV-2 antigen tests to the National Health Service (NHS) in the United Kingdom. Under the company's agreement, the NHS has the right to make reoccurring purchases of its SARS-CoV-2 antigen tests based on their needs and requirements. Beginning March 31, 2022, the purchasing transitioned from DHSC to individual NHS units and departments who are able to continue to purchase all approved LumiraDx products.
Intellectual Property
The company's patent portfolio consists of patent families assigned to its subsidiaries LumiraDx UK, Ltd. and SureSensors Limited, and includes granted U.S. and ex-U.S. patents, pending provisional or priority applications filed in the U.S. or the U.K., pending U.S. and ex-U.S. patent applications that are undergoing or will undergo substantive examination, and applications filed under the Patent Cooperation Treaty, or PCT, from which the company will be able to pursue regional or national phase patent applications that will be subject to substantive examination. The company will continue to file additional patent applications as it deems appropriate and of commercial value.
As of December 31, 2022, the company's patent estate included at least 18 U.S. patents, at least 100 foreign patents, 13 pending U.S. non-provisional patent applications, two pending PCT patent applications, at least 50 pending foreign patent applications, and 4 pending U.S. provisional applications relating to its Platform technologies, clinical assays, Amira System, and related technologies, for example, assay formats or protocols that it may implement on its test strips. The patents and patent applications in eight separate patent families are discussed in more detail below and relate to more aspects of the company's Platform technologies, its clinical assays, and its Amira System. Some of these patent families are still at an early stage of examination or have not yet received substantive examination.
The company owns at least five families of patent applications, at different stages of filing and prosecution, directed to its Platform technologies, that seek to protect various aspects of its Instrument, test strips, and other technologies generally applicable to its various strip assays.
The first patent family has a granted U.S. patent, two granted European patents (each of which has been validated at least in the U.K., Germany, France, Ireland, and Italy), and granted patents in Australia, Argentina, China, Israel, Korea, Hong Kong, Russia, Mexico, Singapore, and South Africa, and applications pending in the U.S., Canada, and a number of countries in Asia. The claims in this patent family are directed to various aspects of the company's Instrument and test strips. The term of the validated patents will expire, and the term of any patents granted on the pending applications would expire, in 2037, in each case subject to the timely payment of the requisite annuities or other renewal fees.
A second patent family contains a U.S. application, and regional or national applications in Canada, China, Europe and Japan that contain claims directed to certain aspects of the magnetic capture technologies implemented in the company's Instrument. The terms of any patents resulting from such regional or national stage applications would expire in 2039, in each case subject to the timely payment of the requisite annuities or other renewal fees.
A third patent family contains pending, Taiwanese and U.S. patent applications and regional or national applications in Australia, Brazil, Canada, China, Europe, Japan, Korea directed to additional features of the company's Instrument and test strip technologies, including specific embodiments of its SARS-CoV-2 tests. The terms of any patents resulting from the regional or national stage applications would expire in 2041, in each case subject to the timely payment of the requisite annuities or other renewal fees.
A fourth patent family directed to the company's STAR nucleic acid amplification system has a granted European patent (validated in the U.K., Germany, Ireland, France, Italy, Spain and the Netherlands) which is under opposition, and granted patents in Australia, China, Hong Kong, Japan, Korea, Singapore, Taiwan, South Africa and Russia and pending applications in the U.S., Argentina, Canada, and Brazil. The term of the patents will expire, and the term of any patents granted from the pending patent applications would expire, in 2037, in each case subject to the timely payment of the requisite annuities or other renewal fees.
A fifth patent family directed to the company's qSTAR nucleic acid amplification system has a granted patent in Europe (validated in Germany, France, Ireland, Italy, Spain, Switzerland and the U.K.), granted patents in Hong Kong, Japan and South Africa, and patent applications pending in the U.S., Canada, South America, and countries in Asia. The term of these patents and any patents granted from these applications would expire in 2039, in each case subject to the timely payment of the requisite annuities or other renewal fees. The company plans to seek patent protection for other aspects of its Platform technologies as they are developed.
With regard to its clinical assays, the company has applied for and, if available, will continue to apply for, patent protection for the assays that will be implemented on its Platform. The company has a sixth patent family containing pending patent applications in Canada, China, Europe, Japan, and the U.S.; the terms of any patents resulting from these applications would expire in 2039, in each case subject to the timely payment of the requisite annuities or other renewal fees. The third Platform patent family seeks to protect certain features of the company's SARS-CoV-2 tests; any regional or national stage applications based on this PCT application that issue as patents would expire in 2041, in each case subject to the timely payment of the requisite annuities or other renewal fees.
The company has a seventh patent family containing pending patent applications in the U.S. and Europe directed to its HbA1c assay; the terms of any patents resulting from these applications would expire in 2040, in each case subject to the timely payment of the requisite annuities or other renewal fees.
The company has an eighth patent family containing an International (PCT) application directed to its Amira System. The term of any resulting patents based on these filings would expire in 2041, in each case subject to the timely payment of the requisite annuities or other renewal fees.
Government Regulation
The company's IVD devices also are subject to the Clinical Laboratory Improvements Act of 1988 (CLIA) and its implementing regulations in the United States, which establish quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test is performed.
The company's products contain radio communicating transmitters, which are subject to regulations enforced by the Federal Communications Commission.
The regulations with which the company is required to comply have been issued in final form under the federal Health Insurance Portability and Accountability Act of 1996, as amended (HIPAA) and include: privacy regulations, security regulations and standards for electronic transactions, which establish standards for common healthcare transactions.
In the United States, there are various fraud and abuse laws with which the company must comply and it is potentially subject to regulation by various federal, state and local authorities, including the Centers for Medicare & Medicaid Services (CMS), other divisions of the U.S. Department of Health and Human Services (e.g., the Office of Inspector General), the Department of Justice (DOJ), and individual U.S. Attorney offices within the DOJ, and state and local governments.
Competition
The company primarily faces competition in the in vitro diagnostic (IVD) market from public and private companies, such as Abbott Laboratories; Becton; Dickinson and Company; Danaher Corporation; GenMark Diagnostics, Inc.; Laboratory Corporation of America Holdings; Quest Diagnostics Incorporated; QuidelOrtho Corporation; Roche Diagnostics Corporation; Siemens Healthineers AG, Inc.; and many others. For each of the company's eight available tests, the company faces competition from other commercially available tests, including:
For its SARS-CoV-2 antigen test and SARS-CoV-2 antigen pool test: Lateral flow tests, such as Quidel Sofia, BD Veritor Plus System, Abbot BinaxNow COVID-19 Ag Card and others, as well as molecular tests, such as Cepheid GeneXpert, Abbott ID NOW and lab-based RT-PCR tests.
For its SARS CoV-2 antibody test: Accelerate Diagnostics BioCheck, Assure Rapid Test, SD Biosensor Q Rapid Test, general lateral flow tests and others.
For its SARS-CoV-2 & Flu A/B tests: Quidel Sofia, BD Veritor Plus System, Cepheid GeneXpert and others.
For its INR test: Roche Coaguchek and others.
For its D-Dimer and NT-proBNP tests: Roche Cobas h232, Quidel Triage, Boditech iChroma and others.
For its CRP test: Abbott Afinion, Aidian QuickReadGo, and others.
For its HbA1c test: Abbott Afinion, Siemens DCA Advantage, and others.
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