12 January 2021
New York State grants permit for CLIA laboratory, expanding access to COLVERA test to patients in all 50 states
BRIDGEWATER, N.J. —January 11, 2020 — Clinical Genomics (“CG” or the “Company”), a provider of cancer diagnostic solutions, including liquid biopsy tests, today announced that the New York State Department of Health (“NYSDOH”) has issued a permit to enable New York patients to access COLVERA, the Company’s liquid biopsy test designed to detect residual and recurrent disease in colorectal cancer (“CRC”). COLVERA now has availability to all 50 states.
The Clinical Laboratory Improvement Amendments (“CLIA”) regulate laboratory testing and require clinical laboratories to be certified by the Centers for Medicare and Medicaid Services (“CMS”) before laboratories can accept human samples for diagnostic testing.
The New York State Department of Health’s (“NYSDOH”) Clinical Laboratory Evaluation Program (“CLEP”) regulates and oversees clinical diagnostic laboratories that test biological specimens from New York State residents.
“NYSDOH is a highly rigorous regulatory body, and the issuance of this permit validates the quality of our CLIA laboratory in Bridgewater, New Jersey,” stated Dr. Naima Loayza, Lab Director for Clinical Genomics. “New York’s CLEP is known to hold to the highest standards for laboratory developed tests, and we believe that its licensure of our clinical laboratory reflects the high quality standard and precision of our COLVERA testing capabilities,” added Dr. Loayza.
“COLVERA is a potentially lifesaving test for CRC patients. Expanding availability to New York means that all U.S. patients now have access to this important diagnostic test and is an important achievement for CG as we build our capabilities. We are well-positioned to advance our commercial expansion plans, including increasing awareness of COLVERA’s clinical and health economic advantages compared to the current standard of care and emerging products in the sector as supported by a large body of peer-reviewed published data,” said Betsy Hanna, President and CEO.
COLVERA is a blood test that detects aberrant methylation in two genes, BCAT1 and IKZF1, found at a high frequency (>95%) in CRC tumor tissue. Identification of these tumor-specific epigenetic changes within a blood sample provides a simple, non-invasive way to detect the presence of CRC-associated circulating tumor DNA (“ctDNA”).
COLVERA can aid physicians in managing patients previously treated for CRC who are undergoing follow-up testing to assess the presence of residual or recurrent disease. COLVERA has been demonstrated in multiple peer-reviewed studies to identify more patients with recurrent and residual colorectal cancer than the current guidelines-recommended standard of care blood test, carcinoembryonic antigen (“CEA”).1
About Clinical Genomics
Clinical Genomics is dedicated to improving patient outcomes through early detection of colorectal cancer. Clinical Genomics’ products span the full spectrum of colorectal cancer testing from screening to post-treatment monitoring. Clinical Genomics is committed to developing and delivering solutions that provide physicians and their patients with information to help guide earlier and better treatment decisions in cancer care management.
COLVERA is a Laboratory Developed Test supplied by Clinical Genomics Pathology Inc. a CLIA Certified, CAP accredited laboratory in Bridgewater, NJ, USA. COLVERA is the first of its kind blood test to detect circulating tumor DNA for molecular residual disease (“MRD”) assessment and recurrence monitoring in patients previously diagnosed with colorectal cancer. COLVERA targets aberrant methylation of two genes (BCAT1 and IKZF1) and is mutation agnostic. COLVERA does not require any form of tissue biopsy. Introduced in 2017, COLVERA has been ordered by hundreds of colorectal surgeons and medical oncologists across the United States.
About Colorectal Cancer
Colorectal cancer is the third most commonly diagnosed cancer and the second leading cause of cancer-related deaths in the United States, with more than 140,000 people per year expected to be diagnosed with CRC and over 50,000 succumbing to the disease annually. For patients who survive, 30%-50% will experience a recurrence, most within the first two to three years of primary treatment. On average, the lifetime risk of developing colorectal cancer is about one in 23 for men and women combined; however, this varies widely according to individual risk factors.
Future Matters and Forward Looking Statements
Certain statements in this press release constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements that address expectations or projections about the future, including statements about product development, market position, expected expenditures and financial results, are forward-looking statements. Some of the forward-looking statements may be identified by words like “expects,” “anticipates,” “plans,” “intends,” “projects,” “indicates,” and similar expressions. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. These statements are not guarantees of future performance and involve a number of risks, uncertainties and assumptions. Accordingly, the Company’s actual results or performance may differ significantly, positively or negatively, from forward-looking statements made herein. Unanticipated events and circumstances are likely to occur. Factors that might cause such differences include, but are not limited to, anticipated funding proving to be unavailable; intense competition in the market resulting in lower than anticipated revenues or higher than anticipated costs; and general economic conditions, such as the rate of employment, inflation, interest rates and the condition of the capital markets. This list of factors is not exclusive. The Company undertakes no obligation to update any forward-looking statements.
Investor Relations for Clinical Genomics
Lisa M. Wilson
In-Site Communications, Inc.
COLVERA is a registered trademark of Clinical Genomics PTY Ltd.
1 See Musher, Benjamin L. et al. “Evaluation of Circulating Tumor DNA for Methylated BCAT1 and IKZF1to Detect Recurrence of Stage II/Stage III Colorectal Cancer (CRC),” Cancer Epidemiology and Prevention Biomarkers (2020); and Symonds, Erin L. et al. “Circulating epigenetic biomarkers for detection of recurrent colorectal cancer,” Cancer 126.7 (2020): 1460-1469.
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