Biocept Announces that Highmark Has Made a Positive Coverage Determination on Target Selector™ Liquid Biopsy

Biocept, Inc, a leading commercial provider of molecular technologies designed to provide physicians with clinically actionable information to improve the outcomes of patients with cancer, announces that Highmark, America's fourth largest Blue Cross Blue Shield affiliate, has made a positive coverage determination that Biocept's Target Selector liquid biopsy assay has been accepted for medical coverage for use in the diagnosis and treatment of patients with non-small cell lung cancer (NSCLC).  The coverage determination follows two years of evaluation performed by the Allegheny Health Network Cancer Institute of Biocept's liquid biopsy assay to more rapidly assess the molecular status of patients with NSCLC, enabling oncologists to select the most appropriate therapy while also reducing the overall cost of care.

Highmark's coverage determination includes testing with Biocept's assay in health insurances across the insurer's footprint, which includes Pennsylvania, Delaware and West Virginia, where it serves 5.6 million members.  The evaluation was managed by Highmark Health's VITAL Innovation Platform, which facilitates real-world testing of early-stage health innovations, producing evidence related to patient experience, care, and cost outcomes to support potential adoption within Highmark Health, as well as acceleration into the broader healthcare community.  Highmark will be the first insurer in its footprint to provide coverage of the test.  In addition, Allegheny Health Network is the first health system to offer the testing in Highmark's footprint, with others to follow.

"The diagnosis, treatment and care of patients with cancer is among Highmark Health's top priorities and a focus of the VITAL Innovation Platform," said Anil C. Singh, MD, Allegheny Health Network (AHN) System Director of Pulmonary/Critical Care/Allergy-Immunology and Sleep Medicine, and medical advisor to VITAL.  "VITAL's evaluation clearly demonstrates the value of using Biocept's liquid biopsy test in making informed, first-line therapy decisions for patients with non-small cell lung cancer.  Additionally, using a simple blood sample reduced the number of invasive tissue biopsies, which can be challenging in patients with advanced NSCLC."  

The Biocept Target Selector platform was used to molecularly profile the liquid biopsies of newly diagnosed, treatment-naïve advanced NSCLC patients, as well as NSCLC patients who were progressing after initial therapy.  These patients also received tissue biopsy as part of the evaluation.

"This project directly supports Highmark's and AHN's mission to provide members and patients with access to the best care that is available, freeing them to be their best," said Gene G. Finley, MD, deputy director of Allegheny Health Network Medical Oncology and lead investigator on the project.  "In order to realize the full potential of targeted therapies, oncologists require timely and accurate molecular characterization of a patient's cancer for selection of the best possible therapy.  Our study indicated that results of Biocept's liquid biopsy provided clinicians with accurate knowledge about their patients' disease, allowing us to implement more effective and better targeted treatment strategies.  This improves the patient experience and lowers healthcare costs."

"The positive results from our collaboration under the VITAL program further solidifies Biocept's role as a leader in the liquid biopsy field and represents an important movement towards improving care for cancer patients," said Michael Nall, Biocept's president and chief executive officer.  "After several years of participating in the VITAL program, the fact that Highmark has made a positive coverage determination is a testament to the value we bring to patients with cancer and to the healthcare system."

Lung cancer is the leading cause of cancer death in the United States.  The American Cancer Society estimates that approximately 135,720 Americans will die from lung cancer in 2020.   The five-year survival rate for advanced NSCLC is less than 10%.  However, 17–27% of NSCLC patients harbor molecular alterations that can be treated with specific FDA-approved targeted therapies.  

Despite the advances of targeted therapies, a large percentage of patients may not undergo molecular profiling due to a number of practical constraints.  Chief among these is the availability of tissue for molecular testing. Lung cancers are often difficult to biopsy because of their location within what is often diseased lung tissue of elderly patients.  Needle biopsy is the most common technique but often does not yield enough tissue for molecular testing.  Performing a second biopsy is a way of remedying this situation, but these procedures can add to risk and cost, making liquid biopsy (peripheral blood) a more feasible specimen type.

SOURCE Biocept, Inc.

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