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Biocept wins approval for expanded Medicare coverage for its Target Selector assay to detect cancer biomarkers

Biocept Inc (NASDAQ:BIOC) (FRA:B003) said it has received a positive final Local Coverage Determination (LCD) from the Centers for Medicare & Medicaid Services (CMS) Molecular Diagnostics Program (MolDx), which will expand Medicare coverage for use of Biocept’s Target Selector assay to identify the HER2 biomarker from circulating tumor cells (CTCs). The company said the reimbursement decision expands access to testing that provides critical information used to guide targeted treatment options for patients with breast cancer. “This coverage determination for our Target Selector assay is important for physicians and patients, as it expands access to a test that can provide the opportunity to find answers that may otherwise not be available from traditional approaches,” Biocept CEO Michael Nall said in a statement.   READ: Biocept partners with Quest Diagnostics to provide its Target Selector NGS-based liquid biopsy testing for lung cancer “We are very pleased with this achievement and are excited to be making significant progress on a number of fronts that address critical needs in oncology and support public health efforts,” Nall added. Biocept noted that about 20% of breast cancers are HER2-positive, with metastatic cancers more likely to be HER2-positive and roughly 20% of HER2-positive patients experiencing recurrence each year. Thus, given the efficacy of various anti-HER2 therapies, testing for HER2 is one of the most important sources of information used by oncologists in making treatment decisions for patients with breast cancer, the company said. Biocept’s combined cell-based and cell-free liquid biopsy tests assess actionable cancer biomarkers from a patient’s blood and, uniquely, from cerebrospinal fluid (CSF) as well.  The company also announced that it continues to provide coronavirus (COVID-19) testing services to help manage the impact of COVID-19 in long-term care facilities, schools and other public facilities it serves. Biocept said it has received more than 450,000 samples for SARS-CoV-2 testing since launching this service in June 2020. Biocept is a molecular diagnostics company focused on changing the way physicians examine blood in their patients with cancer. The San Diego-based company sells CEE-Sure blood collection tubes and has developed a patented liquid biopsy technology called Target Selector that detects and isolates cancer biomarkers such as circulating tumor cells (CTCs) and cell-free circulating tumor DNA (ctDNA). Contact Sean at sean@proactiveinvestors.com