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Biocept HER2 Assay Gains Coverage Under Medicare Local Coverage Determination for CTC Tests

NEW YORK – Biocept said Wednesday that it has received expanded Medicare coverage for the use of its Target Selector assay to identify HER2-positive circulating tumor cells under a final local coverage determination by the Centers for Medicare and Medicaid Services' Molecular Diagnostics Program providing limited coverage for the use of circulating tumor cell assays.

Effective July 4, 2021, the LCD is not specific to any test technology or brand. It outlines a limited coverage policy for assays that detect biomarkers from circulating tumor cells in instances that meet certain criteria, including use in cancer types with established biomarker testing, as recommended by professional society or national guidelines.

Appropriate uses include diagnosis, risk stratification, prediction, or monitoring of therapy response, where these actions have recognized clinical utility. For coverage, a patient must be either newly diagnosed and not previously tested, or there must be an established rationale for retesting such as demonstrated disease progression or suspicion of treatment resistance.

To be covered, CTC test technologies must have successfully completed a comprehensive technical assessment ensuring analytical validity that is equivalent or superior to tissue-based testing or another already-accepted test for the same biomarker for the same intended use.

In addition to these criteria, CTC testing is only covered under the LCD in instances where tissue-based testing for the biomarker in question is infeasible, repeat biopsy is medically contraindicated, or tissue testing will not provide sufficient information for subsequent medical management, for example, in cases where HER2 overexpression is negative in a tissue biopsy but may be positive in CTCs, due to tumor heterogeneity.

Biocept said its CTC HER2 test has passed the CMS technology review. As such it should be covered for cases that meet the cited criteria, as HER2 is a mainstay of precision oncology and is mandated by professional guidelines for all patients with new primary or newly metastatic breast cancer. Traditionally, testing is performed on tissue samples, but there can be cases where adequate biopsy material is not available and/or repeat sampling is not possible.

"Metastatic tumors often show genetic changes that are associated with disease progression and frequently have features of HER2 gene amplification that are not present in the primary tumor. Target Selector’s ability to both detect and characterize the tumor cells provides critical information to help identify patients who may benefit from advanced targeted therapies, with the potential to significantly improve patient outcomes," Michael Dugan, Biocept’s chief medical officer, said in statement.