An analysis of several multigene breast cancer recurrence signatures suggests that some tests may be better than others at assessing risk of late distant recurrence.
Although a draft guidance last month recommended against use of molecular tests to guide chemotherapy, the group's finalized decision is subject to price negotiation and other adjustments.
An assessment concluded that Oncotype Dx has not demonstrated a significant enough impact on outcomes or cost effectiveness compared to current practice.
Several of the top molecular diagnostic firms presented at the JP Morgan Healthcare Conference on Monday discussing product portfolios, FDA clearances, and plans for 2018.
The stock prices of 17 of the 25 firms in the 360Dx Index fell month over month with Enzo Biochem and Bio-Rad leading decliners.
The firm believes the IsoPSA technology is superior to competitors, but clinicians argue that a lack of comparative studies could hamper adoption of all these tests.
The investment bank previously had a Neutral rating for the company, and it lowered the price target on Genomic Health's stock to $25 from $28.
Genomic Health will test samples from Janssen prostate cancer drug studies to examine whether its test can predict patient outcomes.
The firm said it raised €80 million to fund an expansion of, and new applications for, the Idylla test menu.
A global licensing agreement provides Genomic Health with exclusive rights to Cleveland Diagnostics' proprietary IsoPSA reagent for prostate cancer testing.