23andMe
In Brief This Week: 23andMe, PerkinElmer, SQI Diagnostics, and More
News items for the in vitro diagnostics industry for the week of May 24, 2021.
The new reports link variants in CYP2C19 to the safety and efficacy of two drugs, a commonly prescribed antiplatelet drug and an antidepressant.
OncoCyte Posts $555K in Q3 Revenues, Net Loss Rises
The company beat the consensus Wall Street estimate on the top line but narrowly missed it on the bottom line.Â
Ancestry, 23andMe, DiaSorin, Adaptive Biotechnologies, Others Receive FDA Clearances in August
The FDA granted clearance to consumer genetic testing company Ancestry.com for the over-the-counter use of a health risk test for hereditary thrombophilia.
Stakeholders Scramble to Predict Impact of HHS Move Limiting FDA Ability to Regulate LDTs
The move raises questions about what precisely is an LDT outside of FDA jurisdiction and heightens concerns that poorly validated tests will enter the market and endanger public health.