Blog Coverage: Genomic Health Announces Favorable LCD on Medicare Coverage for Use of Oncotype DX Genomic Prostate Score
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LONDON, UK / ACCESSWIRE / May 8, 2017 / Active Wall St. blog coverage looks at the headline from Genomic Health, Inc. (NASDAQ: GHDX) as the Company announced on May 04, 2017, that Palmetto GBA, a Medicare Administrative Contractor (MAC) that assesses molecular diagnostic technologies, has issued a draft local coverage determination (LCD) for the Oncotype DX Genomic Prostate Score. The LCD recommends Medicare coverage for use of the test in qualified patients with favorable intermediate-risk prostate cancer across the US. Register with us now for your free membership and blog access at:
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The draft LCD, once finalized will enable an estimated 30,000 additional men to have further access to the test to help them decide between active surveillance and immediate intervention. Medicare has covered 50,000 low-risk patients since 2015, and this draft LCD will eventually bring in the total number of Medicare patients eligible for GPS coverage to 80,000.
Recently, on March 29, 2017, the Company announced the presentation of new results from a large multi-center validation study, which confirmed that Oncotype DX Genomic Prostate Score is a strong independent predictor of metastases at 10 years in prostate cancer patients across all National Comprehensive Cancer Network clinical risk groups. The Company additionally announced that Oncotype DX is the only genomic test to provide physicians with an assessment of both the current state and future risk of their patient's cancer.
Oncotype DX
Oncotype DX GPS is a prostate biopsy based 17 genes RT-PCR assay which represents four molecular pathways, hence providing a biological measure of cancer aggressiveness. The test analyzes the molecular pathways from tumor tissue removed during the biopsy to offer an individual score that, in combination with other clinical factors, further clarifies a man's risk prior to treatment intervention. The assay is used to identify men who are considered candidates for active surveillance, including those with a low NCCN level, and favorable intermediate-risk disease. The test is designed to inform decisions between active monitoring or immediate therapy as an initial management strategy.
Oncotype DX will undergo Medicare's review process, which includes a public comment period, finalization, and notification. Once final, LCDs are subject to annual review by the MACs, while Genomic Health will continue to generate scientific data and publications to demonstrate the enhanced clinical utility of the GPS.
Portfolio Growth
Genomic Health is one of the leading providers of genomic-based diagnostic tests that help optimize cancer care by addressing the overtreatment of the disease. The Company leverages its Oncotype IQ Genomic Intelligence Platform where it applies world-class scientific and commercial expertise and infrastructure to drive actionable results for treatment planning.
The Oncotype IQ portfolio of genomic tests and services currently consists of the Company's flagship line of Oncotype DX gene expression tests that are used to monitor treatment decisions for more than 700,000 cancer patients worldwide. On November 01, 2016, the Company announced that the multigene Oncotype DX test, assessed on prostate needle biopsy tumor tissue is a strong predictor of the development of metastasis and prostate cancer death in patients with early-stage prostate cancer.
Post the announcement, on February 16, 2017, the Company announced the highlights of four studies outlining the test's ability to predict disease aggressiveness and refine risk stratification across National Comprehensive Cancer Network.
Stock Performance
At the closing bell, on Friday, May 05, 2017, the stock closed the trading session at $32.68, marginally falling 0.64% from its previous closing price of $32.89. A total volume of 76.57 thousand shares have exchanged hands. Genomic Health's stock price rallied 16.55% in the last three months, 15.03% in the past six months, and 19.27% in the previous twelve months. Furthermore, since the start of the year, shares of the Company have gained 11.19%. At Friday's closing price, the stock's net capitalization stands at $1.10 billion.
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