T2 Biosystems, Inc. is an in vitro diagnostics company and leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes.
The company’s technology enables rapid detection of pathogens, biomarkers and other abnormalities in a variety of unpurified patient sample types, including whole blood, plasma, serum, saliva, sputum and urine, and can detect cellular targets at limits of detection as low as one colony forming unit per milliliter, or CFU/mL.
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T2 Biosystems, Inc. is an in vitro diagnostics company and leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes.
The company’s technology enables rapid detection of pathogens, biomarkers and other abnormalities in a variety of unpurified patient sample types, including whole blood, plasma, serum, saliva, sputum and urine, and can detect cellular targets at limits of detection as low as one colony forming unit per milliliter, or CFU/mL.
The company is targeting a range of critically underserved healthcare conditions, focusing initially on those for which rapid detection may enable faster targeted antimicrobial treatment, improve patient outcomes, and reduce cost. The company’s focus includes three areas – sepsis, bioterrorism, and Lyme disease – which collectively represent a multi-billion dollar market opportunity.
For the year ended December 31, 2023, the company’s primary commercial products included the T2Dx Instrument, the T2Bacteria Panel, the T2Candida Panel, the T2Resistance Panel, and the T2Biothreat Panel. The company’s sepsis products – including the T2Dx Instrument, the T2Bacteria Panel, and the T2Candida Panel – are FDA-cleared products able to detect sepsis-causing pathogens directly from blood. Where traditional diagnostics like blood cultures and post-culture diagnostics may take days to produce results, the company’s products are designed to detect these pathogens in three to five hours. The company’s products provide a significant and sustainable competitive advantage compared to other products in its markets.
Products - Commercially Available
T2Dx Instrument
The company’s T2Dx Instrument, which is FDA-cleared and CE marked, is a fully automated, easy-to-use, bench-top instrument that is capable of running a broad range of diagnostic tests from patient samples, eliminating the need for manual workflow steps, such as pipetting, that can introduce risks of cross-contamination. To operate the system, a tube containing the patient’s blood sample is placed onto a disposable test cartridge, which is pre-loaded with all necessary reagents and consumables. The cartridge is then inserted into the T2Dx Instrument, which automatically processes the sample and then delivers a diagnostic test result in three to five hours. Test results are displayed on screen and can be printed or connected directly to the hospital or laboratory information system.
The T2Dx Instrument eliminates the need for sample purification and analyte extraction often required by other diagnostic technologies, which increases sensitivity and specificity, enables a broad menu of tests to be run on a single platform, and greatly reduces the complexity of the consumables. The T2Dx Instrument is designed to have a simple user interface and to efficiently process up to seven specimens simultaneously.
The commercially available test panels are designed to run on the T2Dx Instrument include T2Bacteria, T2Candida, T2Resistance, and T2Biothreat.
T2Bacteria Panel
T2Bacteria, which is FDA-cleared and CE marked, is a direct-from-blood molecular diagnostic test panel that detects bacterial pathogens found in blood stream infections including: Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, and Escherichia coli. T2Bacteria received FDA clearance in 2018 after the clinical trial demonstrated overall sensitivity of 90% and overall specificity of 98%. In October 2023, the company submitted a 510(k) premarket notification to the FDA to expand the number of pathogens detected on the FDA-cleared T2Bacteria Panel to include the detection of Acinetobacter baumannii and the company received FDA 510(k) clearance in February 2024. These six bacterial pathogens account for approximately 75% of bacterial blood stream infections. These pathogens are often referred to as the ESKAPE pathogens, which are responsible for the majority of nosocomial infections and are often capable of ‘escaping’ the biocidal action of antimicrobial agents, exhibiting multidrug resistance and virulence.
A systematic review of the clinical and economic impact of antibiotic resistance reveals that the ESKAPE pathogens are associated with the highest risk of mortality, thereby resulting in increased health care costs. In the T2Bacteria clinical trial, the mean time for the T2Bacteria Panel to result was 6.46 hours, while the result for blood culture was substantially longer with a mean time to result of 123.8 ± 9 hrs. for a negative result and 51.0 ± 43.0 hrs. for a positive result, and the mean time to species identification was 83.7 ± 47.6 hours. A study published in the Microbiology Open found that T2Bacteria decreased the time to species identification on average by 55 hours faster than blood culture. The rapid detection and identification of the pathogens by T2Bacteria in positive specimens also allowed for the early antimicrobial stewardship interventions with faster initiation of an effective targeted antibiotic therapy in some of the patients, which was captured in another study presented by Paggi R, et al. July 2021 with 29.2% of patients with T2Bacteria positive results switched to an appropriate therapy. In a 2019 study published in Open Forum Infectious Diseases, the data showed that patients diagnosed using T2Bacteria had shorter hospital stays, on average, as compared with patients diagnosed using blood culture alone. In August 2019, Centers for Medicare & Medicaid Services, or CMS, granted approval for a New Technology Add-on Payment, or NTAP, for T2Bacteria, effective October 1, 2019, which was extended until September 30, 2022. In its 2020 inpatient prospective payments system final rule, CMS explained: ‘the T2Bacteria Panel represents a substantial clinical improvement over existing technologies because it reduces the proportion of patients on inappropriate therapy, thus reducing the rate of subsequent diagnostic or therapeutic intervention, as well as length of stay and mortality rates caused by sepsis causing bacterial infections’.
T2Bacteria can enable clinicians to achieve faster targeted antibiotic therapy, improve patient outcomes, and reduce costs. The adoption of the T2Dx Instrument and T2Bacteria can enable clinicians to make earlier and more informed decisions by providing positive test results to direct therapy and negative test results to reduce the use of antibiotics.
T2Candida Panel
T2Candida, which is FDA-cleared and CE marked, is a direct-from-blood molecular diagnostic test panel that detects the most lethal form of common blood stream infections that cause sepsis, candidemia, which has an average mortality rate of approximately 40%. T2Candida detects five species of Candida, directly from certain human whole blood specimens, including Candida albicans, Candida tropicalis, Candida krusei, Candida glabrata, and Candida parapsilosis. T2Candida received FDA clearance in 2014 after the clinical trial demonstrated overall sensitivity of 91% and overall specificity of 99%. These five Candida species account for approximately 90% of Candida blood stream infections.
In 2014 the company received FDA marketing authorization for T2Candida in the U.S. and in July 2014 T2Candida was CE marked in the EU.
In April 2015, Future Microbiology published the results of an economic study regarding the use of T2Candida conducted by IMS Health, a healthcare economics agency.
Candidiasis disproportionally affects critically ill children, and a pediatric testing claim for the company’s FDA-cleared T2Candida will allow clinicians to improve outcomes by achieving faster targeted antifungal treatment for their pediatric patients.
Clinical use in Europe and research studies in the United States indicate the strong potential utility for T2Candida in pediatric patients. A Journal of Clinical Microbiology (2022) study conducted at the Bambino Gesù hospital in Rome, Italy found that pediatric patients suspected of fungal bloodstream infections that were tested with T2Candida received species identification results 121.8 hours faster compared to blood culture. The study also found a higher detection rate with T2Candida as six additional probable or possible fungal bloodstream infections in pediatric patients were detected by T2Candida and missed by blood culture. In addition, a prospective observational study published in Clinical Infectious Diseases (2022) evaluated the performance of four pre-blood culture tests for detecting the presence of invasive candidiasis in pediatric patients and found that T2Candida had the highest sensitivity and specificity of all four assays among five hundred patients enrolled. T2Candida was the only test recommended for individual use as a tool for the diagnosis of invasive candidiasis in at-risk children and adolescents.
T2Candida can enable clinicians to achieve faster targeted antifungal therapy, improve patient outcomes, and reduce costs. The adoption of the T2Dx Instrument and T2Candida can decrease the high mortality rate of Candida infections because these products can enable clinicians to make earlier and more informed decisions by providing positive test results to direct therapy and negative test results to reduce the use of antifungal drugs.
T2Resistance Panel
T2Resistance, which is CE marked, is a direct-from-blood molecular diagnostic test panel that simultaneously detects thirteen antibiotic resistance genes from both gram-positive and gram-negative pathogens. T2Resistance is designed to identify the most clinically important carbapenem resistance genes KPC, OXA-48, NDM, VIM, and IMP. Carbapenem resistance has been listed on the CDC Urgent Threat list for antibiotic resistance according to the latest CDC ‘AR Threats Report’. T2Resistance also detects a major source of extended spectrum beta lactamases, or ESBLs, CTXM-14 and CTXM-15; AmpC beta-lactamase genes (CMY, DHA); vanA vanB resistance genes, which are responsible for vancomycin resistant gram-positive enterococcus; and the detection of the methicillin resistance genes mecC and mecA, which cause methicillin resistant Staphylococcus aureus. Clinical performance data demonstrated that the T2Resistance Panel identified carbapenemase resistance genes with an average time of 5.3 hours. Antibiotic resistance was recognized by the World Health Organization in 2017 as ‘one of the biggest threats to global health, food security, and development today’ and in 2022 released the Global Antimicrobial Resistance and Use Surveillance System (GLASS) report.
T2Resistance received FDA Breakthrough Device designation in February 2019 and CE marked in the EU in November 2019 and is available for purchase in the United States as a Research-Use-Only, or RUO, product, meaning that it is in the laboratory research phase of development and is being shipped or delivered for an investigation that is not subject to FDA regulations governing investigational device studies. In December 2021, the company initiated a U.S. clinical trial for the T2Resistance Panel. The clinical trial is expected to be completed in 2024, and the data from this trial may enable submission of a marketing application to the FDA in 2024.
T2Resistance can help to prevent the spread of multidrug-resistant organisms and improve patient outcomes by enabling rapid identification of the genes associated with antibiotic resistance – enabling correct targeted therapy and the reduction of unnecessary antibiotic use, which is a primary cause of antibiotic resistance. The adoption of the T2Dx Instrument and T2Resistance can enable more patients to get on appropriate targeted therapy faster, thereby reducing mortality and lowering hospitalization costs.
T2Biothreat Panel
T2Biothreat is a direct-from-blood molecular diagnostic test panel that runs on the T2Dx Instrument and simultaneously detects six biothreat pathogens, including the organisms that cause 1) anthrax (Bacillus anthracis); 2) tularemia (Francisella tularensis); 3) glanders (Burkholderia mallei); 4) melioidosis (Burkholderia pseudomallei); 5) plague (Yersinia pestis); and 6) typhus (Rickettsia prowazekii). These pathogens have been identified as threats by the CDC and identified as material biological threats under section 319-2(c)(2)(A)(ii) of the Public Health Service Act. If not treated promptly, these pathogens can have mortality rates of 40-90%. T2Biothreat is indicated as an aid in the diagnosis of anthrax, tularemia, melioidosis, glanders, typhus fever and plague.
In December 2021, the company initiated a U.S. clinical evaluation for T2Biothreat that included positive samples being prepared and analyzed at a high-containment Biosafety Level 3 laboratory and negative samples being analyzed at a clinical site. The company’s clinical evaluation of T2Biothreat demonstrated positive percent agreement, or sensitivity, of 100% for all targets except Francisella tularensis, which was 94.3%, and negative percent agreement, or specificity, for all six targets of 100%. On May 8, 2023, the company submitted a 510(k) premarket notification to the FDA for T2Biothreat. On September 19, 2023, the company received 510(k) clearance from the FDA for T2Biothreat.
The six biothreat pathogens detected by the T2Biothreat are identified as biological threats by the U.S. Administration for Strategic Preparedness and Response, or ASPR. ASPR engages partners through Public Health Emergency Medical Countermeasures Enterprise activities to share information and coordinate plans and actions to ensure the nation has and can use medical countermeasures to protect Americans during disasters and emergencies resulting from known and unknown chemical, biological, radiological, or nuclear threats and emerging infectious diseases.
T2Biothreat can help to protect Americans from the consequences of deliberate or naturally occurring outbreaks of these biothreat pathogens by enabling clinicians to achieve faster targeted antibiotic therapy, improve patient outcomes, and reducing mortality. The adoption of the T2Dx Instrument and T2Biothreat can enable clinicians to make earlier and more informed decisions by providing positive test results to direct therapy and negative test results to reduce the use of antibiotics.
Products In Development
T2Lyme Panel
T2Lyme is a direct-from-blood molecular diagnostic test designed to run on the T2Dx Instrument and detect Borellia burgdorferi, the bacteria that causes Lyme disease. T2Lyme may benefit from similar advantages provided by the company’s technology, including the potential for high sensitivity, high specificity, ease of use and more rapid time to result. T2Lyme is designed to provide accurate and timely diagnosis of early Lyme disease, enabling faster targeted treatment, with the goal of preventing the evolution of the disease to its later stages with associated neurological and musculoskeletal diseases.
The company’s technology can address the significant unmet need associated with Lyme disease, a tick-borne illness that can cause prolonged neurological disease and musculoskeletal disease. For patients with Lyme disease, early diagnosis and appropriate treatment significantly reduces both the likelihood of developing neurological and musculoskeletal disorders, as well as the significant costs associated with treating these complications. Multiple diagnostic methods are used to test for Lyme disease, which are labor-intensive, can take weeks to process, and are subject to high false negative rates due to their inability to detect the disease, making each method unreliable in the diagnosis of the condition. Because of these limitations, patients are frequently misdiagnosed or are delayed in the diagnosis of this disease.
The T2Lyme Panel received FDA Breakthrough Device designation in July 2022 as an aid in the diagnosis for the detection of early Lyme disease caused by Borrelia burgdorferi, directly from human whole blood. The company is exploring commercial opportunities with partners and initially plan to launch T2Lyme as a Laboratory Developed Test, or LDT.
T2Cauris Panel
The company’s T2Cauris Panel is a direct-from-blood molecular diagnostic test designed to run on the T2Dx Instrument and detect Candida auris. The company intends to complete product development and seek FDA 510(k) clearance to include the detection of Candida auris on T2Candida, which is already FDA-cleared and CE marked. T2Cauris received FDA Breakthrough Device designation in July 2023.
The company previously collaborated with the CDC regarding C. auris detection using the company’s technology. The goals of the CDC collaboration were to use the T2Dx Instrument to (i) validate the detection of C. auris from patient skin samples and hospital environmental samples, (ii) validate a process for surveillance of C. auris in healthcare facilities from skin and environmental samples, and (iii) assist state and local public health labs in combating the outbreak. The CDC evaluated the T2Cauris swab test on patient skin samples and published their findings in Mycoses. Additionally, in a study presented at ASM Microbe 2018 regarding the detection of C. auris, it was found that the company’s technology provided accurate diagnostic results from patient skin samples.
Following the company’s collaboration with the CDC, the company has completed feasibility and early development of a diagnostic test to detect the C. auris pathogen directly-from-blood and the company plans to seek FDA 510(k) clearance to add this test to T2Candida. Adding C. auris detection to the company’s existing T2Candida Panel will increase the value proposition of T2Candida by covering approximately 95% of all sepsis-causing Candida pathogens commonly found in blood stream infections. The FDA-cleared T2Candida Panel simultaneously detects five Candida species, including Candida albicans, Candida tropicalis, Candida parapsilosis, Candida krusei, and Candida glabrata. Rapid detection of these pathogens, as well as Candida auris, is essential to getting infected patients on appropriate antifungal therapy, improving patient outcomes, and reducing cost.
Sales, Marketing and Distribution
The company’s sales team and its distribution partners employ a strategic approach focusing on the clinical value of the company’s products, improved patient outcomes and economic value for hospitals, including providing these hospitals with a customized budget-impact analysis. They also demonstrate the ease-of-use of the company’s products and highlight the advantages of its products over existing culture-based diagnostics and empiric therapy practices.
In the U.S., the company markets and sells the T2Dx Instrument, T2Bacteria Panel, and T2Candida Panel products directly to hospitals. The company has received FDA 510(k) clearance for these products, and the company expects to receive FDA 510(k) clearance for additional products in the company’s pipeline. At the end of 2023, the company’s direct commercial organization consisted of 27 people, including sales, marketing, medical affairs, service, and support. If hospitals optimize the full extent of the company’s technology, the company expects a positive network effect in the hospital community, helping to accelerate adoption of T2Bacteria and T2Candida.
Internationally, the company markets and sells the T2Dx Instrument, T2Bacteria, T2Candida, and T2Resistance products through territory exclusive distribution partners. The company has received marketing authorization, or certifications, covering Europe, Australia, and certain countries in the Middle East, Latin America, Asia Pacific, and Africa, and expect to seek regulatory authorizations or certifications in additional international markets. The company has affixed a CE mark on the T2Dx Instrument and the T2Candida, T2Bacteria and T2Resistance panels. As of the end of 2023, the company had distributors throughout the EU, and in a growing number of countries in the Asia Pacific, Latin America, and the Middle East. These distributors typically have strong, existing relationships with key opinion leaders, have relationships with important hospitals in their respective countries, and have experience marketing and selling infectious disease and/or microbiology products. The company has employed a small regionally-focused commercial team of business managers and field service personnel primarily to support the efforts of the company’s international distributors, and the company plan to further expand the company’s distribution channels in other key international markets.
The company is marketing, and intends to sell, T2Biothreat directly to the U.S. government agencies tasked with defending the United States from bioterrorism threats.
Customers
The company’s total revenues are concentrated among a small number of large customers. For the year ended December 31, 2023, two customers represented 29% of the company’s total revenue.
Medical and Clinical Affairs
The key decision-makers at hospitals are infectious disease and critical care physicians, laboratory directors, hospital pharmacy, chief medical officers, and hospital administrators. Accordingly, the company continues to educate these key decision makers through in-person meetings, publishing scientific data in peer-reviewed journals, presenting at major industry conferences, and conducting and supporting clinical studies. The company’s clinical and medical affairs team is raising awareness by amplifying clinical value messaging for the company’s products. The team is actively engaged with key opinion leaders to generate and share real world data via scientific journal publications, at medical conferences, and at industry trade shows. During 2023, the company’s products were mentioned in over 35 publications, posters, and presentations.
In response to the severity and complexity of managing bloodstream infections, a growing number of hospitals have instituted sepsis committees or antimicrobial stewardship committees to control hospital practices related to infections, including the use of antibiotic and antifungal therapy. These committees typically include key decision-makers, and they can provide a central forum to present the benefits of the company’s products. In addition, the company plans to continue to publish scientific data in peer-reviewed journals, present at major medical and scientific conferences and conduct and support clinical trials to provide additional data relative to the performance of T2Bacteria, T2Candida, and T2Resistance to these key decision-makers.
Manufacturing
The company’s particles are supplied by a sole source supplier, Cytiva (a Danaher company), formerly GE Healthcare.
The company has implemented a quality management system designed to comply with FDA regulations and International Standards Organization, or ISO, standards governing medical device products. These regulations govern the design, manufacture, testing, release, installation and service of diagnostic products, as well as raw material receipt and control. The company has received ISO 13485:2016 certification from the National Standards Authority of Ireland. The company’s key outsourcing partners are also ISO-certified.
Intellectual Property
The company owns or exclusively licenses over 40 issued U.S. patents and U.S. patent applications. The company also owns or licenses over 50 pending or granted counterpart applications worldwide. The company possesses substantial know-how and trade secrets which protect various aspects of the company’s business and products. The patent families comprising the company’s patent portfolio are primarily focused on protection of a range of general and specific attributes of the company’s proprietary assay architecture and assay instrumentation for the company’s T2Bacteria, T2Candida, T2Resistance, T2Biothreat, T2Lyme, and T2Cauris Panels and the company’s product candidates, as well as protection of certain aspects of the conduct of the assays and detection of analytes. The company’s patent portfolio includes issued patents that cover T2Bacteria, T2Candida and T2Lyme.
License Agreements
In 2006, the company entered into an exclusive license agreement with Massachusetts General Hospital, or MGH, pursuant to which MGH granted to the company an exclusive, worldwide, sublicensable license under certain patent rights to make, use, import and commercialize products and processes for diagnostic, industrial and research and development purposes. In 2008 and 2011, the company amended its agreement with MGH to add patent rights and to modify, among other things, the company’s diligence and payment obligations.
Supply Agreement with SMC Ltd.
The company is party to a supply agreement with SMC Ltd. for the supply and manufacture of plastic injection molded parts that are used across all T2 Biosystems' test panels. The agreement contains other terms and conditions generally consistent with an agreement for the manufacture and supply of materials or products for use in the development and commercialization of diagnostics, such as the company’s products and product candidates, including with respect to ordering, supply of such product in accordance with specifications, and quality assurance and quality control activities.
BARDA Contract
In September 2019, BARDA (Biomedical Advanced Research and Development Authority) awarded the company a milestone-based contract for the development of a next-generation diagnostic instrument, a comprehensive sepsis panel and a multi-target biothreat panel. In April 2021, BARDA agreed to modify the contract to accelerate product development by advancing future deliverables and adding a U.S. T2Resistance Panel into Option 1 of the contract. In September 2021, BARDA exercised Option 2A to further advance the new product development initiatives. In December 2021, the company initiated the U.S. clinical trials for the T2Resistance Panel and T2Biothreat Panel. In March 2022, BARDA exercised Option 2B. In May 2022, BARDA exercised Option 3 to complete the U.S. clinical trials for the T2Resistance Panel and T2Biothreat Panel and subsequently submit applications to the FDA for the U.S. regulatory clearance for those product candidates. In December 2022, the T2Biothreat clinical evaluation was completed. In May 2023, the company submitted a 510(k) premarket notification to the FDA for the T2Biothreat Panel and in September 2023, the company received 510(k) clearance from the FDA to market the T2Biothreat Panel. The BARDA contract expired in September 2023.
Government Regulation
The company’s products and its operations are subject to significant government regulation by the FDA and other federal, state, and local regulatory authorities, as well as comparable authorities in other jurisdictions. The company’s products are subject to regulation as medical devices under the Federal Food, Drug, and Cosmetic Act, or FDCA, as implemented and enforced by the FDA.
A certain number of the company’s products have received 510(k) clearance from the FDA for various indications for use. To obtain 510(k) clearance, the company must submit a pre-market notification to the FDA demonstrating that the proposed device is substantially equivalent to a previously cleared 510(k) device, a device that was in commercial distribution before May 28, 1976 for which the FDA has not yet called for the submission of pre-market approval applications, or is a device that has been reclassified from Class III to either Class II or I.
Some of the company’s products, including its T2Resistance Panel and T2Cauris Panel are available RUO. As a manufacturer, the company is subject to periodic scheduled or unscheduled FDA inspections.
Research and Development Expenses
The company’s research and development expenses were $14.2 million for the year ended December 31, 2023.
Competition
The company competes with companies that provide traditional blood culture-based diagnostics, including Becton Dickinson & Co., bioMerieux, Inc. (and its affiliate, BioFire Diagnostics, Inc.) Bruker Corporation, Accelerate Diagnostics, Luminex, Roche, Cepheid and Beckman Coulter, a Danaher company.
History
T2 Biosystems, Inc. was founded in 2006. The company was incorporated in 2006 as a Delaware corporation.
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