StageZero Life Sciences Ltd. focuses on developing and commercializing proprietary molecular diagnostic tests for early detection of diseases and personalized health management, with a primary focus on cancer-related indications.
The company has developed a proprietary platform technology, the Sentinel Principle, to identify novel biomarkers from whole blood. The company’s lead product, ColonSentry, is a blood test to determine an individual’s risk for having colorectal cancer.
During the year...
StageZero Life Sciences Ltd. focuses on developing and commercializing proprietary molecular diagnostic tests for early detection of diseases and personalized health management, with a primary focus on cancer-related indications.
The company has developed a proprietary platform technology, the Sentinel Principle, to identify novel biomarkers from whole blood. The company’s lead product, ColonSentry, is a blood test to determine an individual’s risk for having colorectal cancer.
During the year-ended 2020, the company offered various COVID-19 tests, such as polymerase chain reaction (PCR) tests and antibody tests. PCR tests can detect COVID-19 nucleic acid from patient nasopharyngeal swab specimens or saliva, and are used to diagnose an active COVID-19 infection.
The company has wholly-owned subsidiary companies, StageZero Life Sciences Holdings, which owns 100% of StageZero Life Sciences Inc. (Inc.) in the United States.
Technology and Products
The Sentinel Principle
The Sentinel Principle is an award-winning fundamental technology developed by the company. It is based on the premise that as blood circulates through the body, communication occurs between cells in blood and tissue. These cell to cell interactions induce changes in blood gene expression resulting in the presence of specific RNA (ribonucleic acid) molecules. Profiling these changes enables tests based on this technology to identify unique molecular signatures reflecting disease activity, which can then be used to develop disease-specific molecular diagnostic assays. The company has used the Sentinel Principle to develop disease-specific blood-based biomarkers as the basis for molecular diagnostic tests and to enable personalized health management.
In addition to colorectal cancer (CRC), the company has applied the Sentinel Principle to more than 20 disease areas in its research although the company has not developed any tests associated with these disease areas.
ColonSentry
The company’s lead product, ColonSentry, is based on the Sentinel Principle and is a blood-based molecular test to aid physicians in determining an individual’s risk of having CRC. ColonSentry uses a molecular laboratory technology known as qRT-PCR (quantitative Real Time PCR) and is performed on total RNA isolated from a patient’s blood. It measures the mRNA expression levels of the seven biomarkers the company has identified as indicating CRC risk. The results are converted into a patient’s personalized risk score for CRC using an algorithm. This approach targets at-risk patients who are non-compliant with colonoscopy guidelines.
To demonstrate the clinical utility of ColonSentry, in 2013, the company entered into an agreement with Geisinger Health System (GHS) for a prospective study offering the ColonSentry test to eligible patients (CRC screening is indicated but have refused colonoscopy). GHS offers both health-care services and insurance coverage to nearly three million patients throughout Pennsylvania.
Market and Sales
The company focuses on expanding the U.S. commercialization through StageZero Life Sciences Inc. (in all states except for New York and New Jersey).
EarlyCDT-Lung
The company in-licensed EarlyCDT-Lung in 2014. However in 2019, the company shifted its focus to later stage cancer diagnosis. The company can refer patients for the test, but it no longer processes the test in its lab.
Prostate Health Index (PHI) Test
In 2014, the company added Beckman Coulter Diagnostics ’PHI test to its menu of cancer assays. StageZero Life Sciences Inc. is the first laboratory selling this test across the United States. The PHI test is a simple blood test that is three times more specific in detecting prostate cancer than the widely used prostate-specific antigen (PSA) test. The PHI results are intended to be used as an aid in distinguishing prostate cancer from benign prostatic conditions in men 50 years of age and older with total PSA results in 2 -10 ng/mL range and a negative digital rectal exam (DRE).
Market and Sales
The company has signed an agreement with the University of Texas MD Anderson Cancer Center (MD Anderson) and is pursuing interest from hospital groups and large physician practice groups for this test.
BreastSentry
In 2014, the company had in-licensed two biomarker assays, sphingotest pro-NT and sphingotest pro-ENK, which could aid physicians in identifying those women in the general population who have an elevated risk of breast cancer. These tests were developed by sphingotec GmbH, a German company that expanded into the United States. It is best known for the discovery and development of biomarker assays.
Pursuant to a license and cooperation agreement in respect of the two biomarker assays dated October 2014 between GeneNews Corporation, StageZero Life Sciences Inc. (GeneNews Corporation and StageZero Life Sciences Inc. are the ‘Cooperation Partners’) and sphingotec GmbH, sphingotec GmbH granted the Cooperation Partners a non-exclusive, non-transferable licence to use certain patents and know-how owned by sphingotec GmbH in the United States. The sole purpose of the agreement is the developing, validating, marketing, selling and using a laboratory developed test (LDT), developed and validated by StageZero Life Sciences Inc., using sphingotec GmbH’s two biomarker assays, sphingotest pro-NT, and sphingotest pro-ENK. Pursuant to the agreement, sphingotec GmbH reserved the right to issue licenses in respect of the biomarkers for, among other formats, in-vitro diagnostic systems. BreastSentry was successfully launched in March 2017, with a first introduction via a multi-specialty physician group in the Midwest. An expanded launch across the U.S. was initiated in the second quarter of 2017, with roll-out continuing throughout 2017.
Market and Sales
BreastSentry measures the fasting plasma levels of proneurotensin (pro-NT) and proenkephalin (pro-ENK), which are highly predictive of a woman's risk for developing breast cancer.
COVID-19 Tests
The company is offering PCR and antibody tests for COVID-19.
The COVID-19-PCR test is a real-time reverse transcription polymerase chain reaction (rRT-PCR) test for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal specimens from individuals suspected of having COVID-19. Test results indicate whether the patient has the COVID-19 infection.
In conjunction with clinical presentation and results of other laboratory tests, the COVID-19 IgG/IgM Antibody Test, an in-vitro immunoassay for the direct and qualitative detection of antiSARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human serum, plasma or venipuncture whole blood aids in the diagnosis of COVID-19. Detection of IgM antibodies indicates recent infection, while IgG antibodies gradually appear and increase in the late stage of infection. It is not known how long these antibodies persist in the blood after infection. This test is for professional in-vitro diagnostic use only. Blood samples are drawn from patients and are shipped to the company’s federal Clinical Laboratory Improvement Amendments of 1988 certified, CAP accredited lab in Richmond, Virginia.
Potential Future Pipeline Development and Research
The company focuses on commercialization efforts through StageZero Life Sciences Inc., including the sourcing of additional tests to in-license from third parties. As a result, the company is not actively pursuing in-house development of additional COVID tests, but are filing several Emergency Use Authorization’s for specific use of tests. The company has also added a Respiratory Panel for the identification of multiple respiratory pathogens and is adding an Inflammatory Pathway Panel to supplement the cancer diagnostic program. Expansion of the number of cancers able to be detected by the Aristotle program remains a focus.
The company has established collaborations and alliances with leading institutions to access well-defined clinical sample and data sets, as well as expert clinical guidance and insight from respected leaders in cancer, cardiovascular disease and neurological disorders. It also maintains relationships with many leading institutions, including Brigham and Women’s Hospital of Harvard Medical School, University Health Network at University of Toronto, University of California at San Francisco, New York University School of Medicine, Memorial Sloan Kettering Cancer Center in New York, and Stanford University in California.
Intellectual Property
As of December 31, 2020, the company had 1 issued U.S. patent. Its patent portfolio is centered around its core technology, the Sentinel Principle and the company’s lead product, ColonSentry. The related patents are protected in key marketing jurisdictions, such as the United States and Canada. The company also has 6 core trademarks (both registered and pending), including the company’s house mark and families of marks built around the Sentinel Principle and ColonSentry, many of which are being protected in multiple jurisdictions.
Regulatory Framework
The company must comply with the federal Clinical Laboratory Improvement Amendments of 1988 and all applicable state requirements. Claims for payment submitted by the company to federal healthcare programs (e.g., Medicare, Medicaid, TRICARE, etc.) are subject to various federal fraud and abuse laws (e.g., Anti-Kickback Statute, False Claims Act, etc.).
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