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The US Food and Drug Administration has asked questions about Myriad Genetics' GeneSight test, according to Bloomberg.
The firm reported total revenues of $215.4 million, up from $193.9 million in fiscal Q4 2018, but below the consensus Wall Street estimate of $221.0 million.
The test will be used to identify which metastatic, castration-resistant prostate cancer patients harbor germline BRCA mutations and will likely benefit from Lynparza.
The firm said that UHC will cover the test for patients with major depressive disorder or anxiety who have failed to respond to one or more treatments.
The company decided to settle the complaint in order to avoid "lengthy and distracting litigation," but denies any wrongdoing.
Five hundred pharmacies will provide information about pharmacogenetic testing to members who have failed one or more antidepressant treatments.
The investment firm also reduced its price target to $30 per share from $37 citing "lower overall conviction" that Myriad would meet its revenue projections.
Authors concluded that all three assays — Oncotype DX, EndoPredict, and Prosigna — met Canadian thresholds for cost-effectiveness and urged caution in considering the findings.
The drug is for first-line maintenance therapy after BRCA-mutated advanced ovarian cancer patients respond to platinum chemo and the test will identify those with BRCA mutations.
Keytruda and Ibrance demonstrate activity in molecularly defined populations, while a new cohort will explore Gilotrif in tumors with NRG1 fusions.
New analyses indicate the P.1 variant found in Brazil may be able to infect people who have already had COVID-19, the New York Times reports.
According to CNBC, Novavax's CEO says its vaccine could be authorized in the US as early as May.
The US National Institutes of Health has a new initiative to address structural racism in biomedical research.
In PNAS this week: GWAS of TLV-1-associated myelopathy/tropical spastic paraparesis, analysis of twins with hypertrophic cardiomyopathy, and more.