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Palmetto Finalizes LCD Expanding Coverage for Genomic Health Prostate Cancer Test

NEW YORK (GenomeWeb) – Genomic Health announced today that national Medicare contractor Palmetto GBA has issued a favorable final local coverage determination expanding coverage of the company's Oncotype DX prostate cancer test.

Oncotype DX prostate provides a genomic assessment of a tumor's aggressiveness in order to help doctors decide which patients are at low enough risk that they can be more conservatively managed. With Palmetto's decision, the test will be recommended for Medicare coverage in patients with favorable intermediate-risk prostate cancer.

Two years ago, Palmetto issued a final LCD approving coverage of Oncotype Dx prostate, but only in patients with biopsy-confirmed localized disease, as well as a number of other clinical factors indicating low or very low risk of disease. Other requirements set out by that decision included that testing only be performed by physicians enrolled in a Palmetto MolDX-approved Certification and Training Registry program, and that physicians monitor tested patients for disease progression and report any cases of metastasis or prostate cancer deaths in patients who were deemed low risk by the assay.

Genomic Health said that once the latest LCD becomes effective on Oct. 9, roughly 20,000 additional men will have access to the test, adding to the existing 50,000 low-risk patients who have been covered since 2015.

"With this additional Medicare coverage we can now broaden the impact of Oncotype DX, the only genomic test validated to predict both the current risk of adverse pathology and future risk of metastasis and death due to prostate cancer, to men with favorable intermediate-risk prostate cancer as defined by the National Comprehensive Cancer Network," Genomic Health Chief Medical Officer Phil Febbo said in a statement.