Skip to main content
Premium Trial:

Request an Annual Quote

Prostate Cancer AR-V7 Test From Genomic Health, Epic Sciences Gets Final Medicare LCD

NEW YORK (GenomeWeb) – Epic Sciences and Genomic Health said today that Medicare Administrative Contractor Palmetto GBA has issued a positive final local coverage determination (LCD) for the Oncotype DX AR-V7 Nucleus Detect test, which was developed and continues to be performed by Epic Sciences.

Palmetto released its draft LCD for the test this March. The final determination recommends limited coverage for use of the test throughout the US to help determine which patients with metastatic castrate-resistant prostate cancer may benefit from continued androgen receptor signaling inhibitor therapy — using drugs like enzalutamide, abiraterone, and apalutamide — and which may be better served by chemotherapy.

The assay uses Epic's "No Cell Left Behind" circulating tumor cell analysis platform to identify AR-V7 positivity in CTC nuclei. Genomic Health partnered with Epic in 2016 to bring the assay to market, and launched it commercially this February.

Studies of the test, including a validation published this June in JAMA Oncology, have shown that detection of AR-V7-positive CTCs indicates that a patient will no longer benefit from commonly prescribed AR inhibitor therapies and will have better survival if switched to chemotherapy.

The Scan

Denisovan Girl's Tooth Found in Laos

CNN reports that a tooth found in a cave north of Vientiane likely belonged to a Denisovan girl.

A Lack of Diversity in Trials

A new report from the National Academies of Science, Engineering, and Medicine examines the limited representation of diverse groups among clinical trial participants.

Another Look

A new inquiry is to be held after genetic evidence indicates that Kathleen Folbigg's children may have been at increased risk of sudden death, the Sydney Morning Herald reports.

Nucleic Acids Research Studies on ICARUS, Neighbor-seq, CADDIE

In Nucleic Acids Research this week: resource to analyze and visualize single-cell RNA-seq data, method to examine cellular interactions, and more.