Clinical Genomics Announces Expansion of Medicare Coverage of COLVERA® Liquid Biopsy for Colorectal Cancer Molecular Residual Disease and Recurrence Detection

-- Coverage for traditional Medicare beneficiaries now expanded to Medicare Advantage plan members --

BRIDGEWATER, N.J. — October 5, 2021 — Clinical Genomics, a provider of cancer diagnostic solutions, including liquid biopsy tests for molecular residual disease (“MRD”) and recurrence monitoring of colorectal cancer (“CRC”), announced today that Novitas Solutions Inc. has updated its Local Coverage Determination “Biomarkers for Oncology” (L35396) to provide coverage for COLVERA®, billed with current procedural terminology (“CPT”) code 0229U for medically necessary tests performed on or after January 1, 2021. This coverage includes reimbursement for COLVERA tests performed for patients covered by the Centers for Medicare and Medicaid Services (“CMS”) throughout the United States.

Novitas initiated coverage for traditional Medicare beneficiaries on July 1, 2020. This update, implemented via the Local Coverage Article associated with L35396 (A52986), expands coverage to patients with Medicare Advantage plans. CMS provides healthcare coverage for all U.S. citizens over the age of 65, as well as assistance to people with low incomes and disabilities. Tests for patients covered under traditional Medicare and Medicare Advantage make up approximately 60% of all COLVERA tests ordered.

“We are pleased that Novitas has expanded its coverage policy for COLVERA to include beneficiaries who have elected to utilize Medicare Advantage plans. The specific language of the coverage policy provides the most expansive coverage of any Medicare policy related to patients previously diagnosed with CRC, and will improve access to this important liquid biopsy technology,” stated Betsy Hanna, President and CEO of Clinical Genomics. “Survivorship care is critical for patients previously diagnosed and treated for CRC. Our goal is to reduce deaths from CRC by regular recurrence monitoring of these patients with a clinically proven test that is cost effective and readily available to our clinician partners. This coverage expansion to Medicare Advantage plans is an important step for all CRC patients, and we look forward to working with private health plans to secure similar coverage for their members,” concluded Hanna.

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 is the first liquid biospsy assay for CRC monitoring and 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, 20%-30 will experience a recurrence, most within the first two years following 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.

Investor Relations for Clinical Genomics:
Lisa M. Wilson
In-Site Communications, Inc.
T: 212-452-2793

COLVERA is a registered trademark of Clinical Genomics Pty Ltd.