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GHDX

Genomic Health

$30.34

0.14 (0.46%)

08:04
10/10/16
10/10
08:04
10/10/16
08:04

Genomic Health reports results from eight Oncotype DX presentations at ESMO

Genomic Health announced results from eight Oncotype DX Breast Recurrence Score presentations at the European Society for Medical Oncology 2016 Congress in Copenhagen, Denmark, highlighting superior clinical evidence in identifying which patients with node-negative and node-positive invasive breast cancer should be treated with chemotherapy. Specifically, prospective clinical outcomes in more than 7,400 patients with node-positive invasive breast cancer from two independent studies show excellent survival in women with RS results less than 18. Two independent studies in more than 7,400 patients from the United States and Israel provide further evidence that Oncotype DX accurately predicts outcomes in patients with early-stage, node-positive invasive breast cancer. Specifically, an updated analysis of the National Cancer Institute's Surveillance, Epidemiology, and End Results Registry results from 6,768 patients who were treated based on RS results showed that in 3,919 patients with a RS of less than 18, breast cancer specific survival was excellent. Specifically, it was greater than 97% in patients with micrometastases, one, or two positive lymph nodes. Similarly, results from a prospective study of more than 700 patients tested with Oncotype DX within Clalit Health Services, the largest health maintenance organization in Israel, showed that patients with micrometastases or one to three positive lymph nodes and a RS less than 18, the vast majority (92.9%) of whom were treated with hormonal therapy alone, had very good outcomes with low rates of distant recurrence (3.2%) and excellent breast cancer survival (greater than99%) at five years.

  • 06

    Nov

GHDX Genomic Health
$30.34

0.14 (0.46%)

06/13/16
CANT
06/13/16
NO CHANGE
Target $13
CANT
Buy
Cantor sees 'flawed methodology' with new CMS rates
Cantor Fitzgerald analyst Bryan Brokmeier says shares of Veracyte (VCYT) may be under pressure this morning following Friday's release of a proposed gapfill Medicare reimbursement rate reduction on the company's Afirma GEC. Along with the 30% reduction on Afirma's GEC, the release from the Centers for Medicare and Medicaid Services resets rates on 15 other molecular diagnostic tests, including reductions in CareDx's (CNDA) AlloMap, which is down 74%, Genomic Health's (GHDX) Oncotype Dx Colon, which is down 73%, and Rosetta Genomics' (ROSG) Cancer Origin Test, which is down 57%, Brokmeier tells investors in a research note. The analyst, however, believes the preliminary proposed gapfill rate is based on a "flawed methodology" because it is the median proposed rate submitted by all Medicare Administrative Contractors, including those that have little or no experience administering claims on these tests, Brokmeier contends. He points out that Medicare represents approximately 20% of Afirma GEC test volume for Veracyte. Based on 2015 volume, the 30% Medicare rate reduction for Afirma would reduce total revenues by $3.7M or 7.5%, he adds. The analyst keeps a Buy rating on Veracyte with a $13 price target.
06/20/16
PIPR
06/20/16
NO CHANGE
PIPR
Final PAMA rule better than expected, says Piper Jaffray
Piper Jaffray analyst William Quirk says the final Protecting Access to Medicare Act published Friday by Centers for Medicare & Medicaid Services is better than expected. PAMA is delayed until 2018 from 2017 as expected, Quirk tells investors in a research note. Hospital labs will be required to submit private payer rates to CMS, a positive relative to prior expectations, the analyst notes. He views the decision as beneficial for Quest Diagnostics (DGX) and LabCorp (LH). Further, CMS will require labs to submit only in-network rates and out-of-network "final" rates, which is a positive for specialty labs who have in-network rates at or above Medicare including CareDx (CDNA), Genomic Health (GHDX), Myriad Genetics (MYGN), Oxford Immunotec (OXFD) and Veracyte (VCYT), Quirk writes.
06/21/16
LEER
06/21/16
NO CHANGE
Target $38
LEER
Outperform
Leerink remains confident on Genomic Health revenue acceleration story
Leerink analyst Dan Leonard remains confident that Genomic Health's revenue acceleration could lead to multiple expansion, adding that recent due diligence highlights efforts to drive growth in the core breast franchise. The analyst reiterates an Outperform rating and $38 price target on the shares.
07/07/16
PIPR
07/07/16
NO CHANGE
PIPR
New FDA recommendation positive for lab companies, says Piper Jaffray
Piper Jaffray analyst William Quirk says that the FDA has issued draft guidance to streamline its approval process for next-generation sequencing, or NGS, germline tests, which could be a substitute for a Premarket Notification or 510k. The analyst believes streamlined regulatory approaches for NGS tests are a positive for labs with NGS laboratory-developed tests such as CareDx (CDNA), Quest Diagnostics (DGX), Genomic Health (GHDX), LabCorp (LH), Myriad Genetics (MYGN), Natera (NTRA), Oxford Immunotec (OXFD), Sequenom (SQNM), Trovagene (TROV), and Veracyte (VCYT).

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