15 November 2020
Updated coverage decision from Novitas Solutions marks major milestone, as Company advances toward full-scale commercialization
BRIDGEWATER, N.J. —November 13, 2020 — Clinical Genomics (“CG” or the “Company”), a provider of cancer diagnostic solutions, including liquid biopsy tests, today announced that Novitas Solutions (“Novitas”), a Medicare Administrative Contractor (“MAC”) processing claims for Medicare, updated its Local Coverage Determination applicable to biomarkers in oncology, including COLVERA, the Company’s liquid biopsy test to detect biomarkers associated with minimal residual disease and recurrence for patients who have been diagnosed and treated for colorectal cancer (“CRC”).
Novitas updated the Local Coverage Determination (“LCD”): Biomarkers for Oncology (L35396) to allow Medicare coverage for COLVERA for medically necessary tests performed on or after July 1, 2020. This determination applies to patients across the United States covered by the Centers for Medicare and Medicaid Services (“CMS”) whose claims for testing are submitted by Clinical Genomics in New Jersey. Medicare beneficiaries currently account for more than 50% of the COLVERA tests ordered by physicians and other licensed clinicians.
Subsequent to the publication of the updated coverage determination, Clinical Genomics has received payment for numerous COLVERA tests that meet appropriate use criteria.
“Receiving Medicare coverage for COLVERA represents a significant milestone for our Company, as we advance toward full commercialization of this important diagnostic. Over the past several years, our employees, both in the U.S. and Australia, in partnership with our academic and physician collaborators, have worked very hard to build the evidence base that supports the clinical validity and utility of COLVERA. We would also like to thank the patients who participated in our clinical trials for their efforts to help us expand access to this potentially life-saving test,” stated Betsy Hanna, CEO of Clinical Genomics.
“This is an important achievement for CG and positions us well to advance our commercial expansion plans, including building awareness of COLVERA’s clinical advantages over the current guidelines recommended standard of care and pursuing reimbursement for patients covered under a wide range of health insurance plans,” concluded Hanna.
COLVERA is a blood test that detects aberrant methylation in two genes, BCAT1 and IKZF1, found at a high frequency (>95%) in colorectal cancer (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 diagnosed with CRC and treated with curative intent who are undergoing follow-up testing to assess the presence of residual or recurrent CRC. COLVERA has been demonstrated in multiple peer-reviewed studies in the U.S. and Australia to offer significantly improved performance compared to 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 prior to use. 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 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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