Skip to main content
Premium Trial:

Request an Annual Quote

Biotheranostics Breast Cancer Test Receives Expanded Medicare Coverage Determination

NEW YORK (GenomeWeb) — Biotheranostics announced today that its Breast Cancer Index (BCI) genomic test has has been issued an expanded local coverage determination (LCD) by Medicare contractor Noridian.

The PCR-based test evaluates the expression of 11 genes to help physicians predict the risk of late disease recurrence and identify which early-stage breast cancer patients are likely to benefit from continuing adjuvant endocrine therapy beyond five years.

In 2014, the BCI received a positive coverage determination from Medicare administrator Palmetto GBA — which runs the Molecular Diagnostic Services Program that establishes Medicare coverage and reimbursement for molecular diagnostics — for its use in early-stage, estrogen receptor (ER)-positive breast cancer patients.

Under the expanded LCD — which will go into effect on April 16 — coverage will include the management of postmenopausal women diagnosed with early-stage, node-negative, non-relapsed, ER and/or progesterone receptor-positive, HER2-negative breast cancer, who are being or will be treated with primary adjuvant endocrine therapy.

"We are pleased that Medicare and Palmetto MolDx have continued to recognize the clinical utility of BCI and the strength of its clinical validation, thus increasing patient and physician access to this important technology," Biotheranostics CSO Catherine Schnabel said in a statement.

About a year ago, San Diego-based Biotheranostics agreed to pay $2 million to settle US Department of Justice allegations that the company improperly billed Medicare for the BCI.

The Scan

Positive Framing of Genetic Studies Can Spark Mistrust Among Underrepresented Groups

Researchers in Human Genetics and Genomics Advances report that how researchers describe genomic studies may alienate potential participants.

Small Study of Gene Editing to Treat Sickle Cell Disease

In a Novartis-sponsored study in the New England Journal of Medicine, researchers found that a CRISPR-Cas9-based treatment targeting promoters of genes encoding fetal hemoglobin could reduce disease symptoms.

Gut Microbiome Changes Appear in Infants Before They Develop Eczema, Study Finds

Researchers report in mSystems that infants experienced an enrichment in Clostridium sensu stricto 1 and Finegoldia and a depletion of Bacteroides before developing eczema.

Acute Myeloid Leukemia Treatment Specificity Enhanced With Stem Cell Editing

A study in Nature suggests epitope editing in donor stem cells prior to bone marrow transplants can stave off toxicity when targeting acute myeloid leukemia with immunotherapy.