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Biotheranostics Settles False Claims Allegations With DOJ for $2M

NEW YORK (GenomeWeb) – The US Department of Justice said on Thursday that Biotheranostics has agreed to pay $2 million to settle allegations that the company improperly billed Medicare for molecular breast cancer tests. 

The DOJ alleged the San Diego-based company promoted and performed its Breast Cancer Index test on breast cancer patients who had not been in remission for five years and who had not been taking tamoxifen. Biotheranostics then billed the Centers for Medicare & Medicaid Services for the tests, although they were unnecessary for those patients, based on published clinical trial data and clinical practice guidelines, DOJ said.

According to Biotheranostics' website, BCI can determine a breast cancer patient's risk of recurrence beyond five years. Using the original tumor biopsy, it evaluates several genes associated with cell proliferation and the estrogen signaling pathway. The test can predict the likelihood of benefit from extended endocrine therapy, the company said.

The DOJ noted that Biotheranostics did not admit to any wrongdoing in the settlement deal.