Qiagen's test is intended to identify advanced bladder cancer patients with alterations in FGFR3 or FGFR2 genes and who are likely to respond to erdafitinib.
For 2019, the firm's total revenues from commercial operations, licensing, and collaborations are expected to grow to more than €3 million.
Pharmacogenetics and legal experts took particular issue with the agency's suggestion that "established" drug/gene relationships are found only in FDA-approved drug labels.
The firm is seeking approval of myChoice HRD as a test that can identify ovarian, fallopian, or peritoneal cancer patients deficient in homologous recombination DNA repair.
The New York Times reports on Scott Gottlieb's plans as he steps down as commissioner of the US Food and Drug Administration.
The agency said the MediMap tests are in violation of Federal Food, Drug, and Cosmetic Act because they are intended, in part, for use in disease diagnosis.
Studies presented at the AACR meeting demonstrated how the registry can be used to evaluate how cancer patients with rare tumor markers respond to treatments.
Norman Sharpless, the current NCI director, is to serve as acting commissioner of the Food and Drug Administration, the New York Times reports.
The budget calls for $34.4 billion for the NIH in the coming fiscal year, including $492 million in resources made available through the 21st Century Cures Act.
The Washington Post reports that some health advocates worry that Commissioner Scott Gottlieb's departure from the US Food and Drug Administration will stall certain initiatives.
According to New Scientist, GEDmatch changed its terms and conditions over the weekend to opt its users out of law enforcement searches.
The Atlantic looks into time spent pursuing gene leads generated through candidate gene studies.
A twin study uncovers evidence that genes may influence whether someone gets a dog, Martha Stewart reports.
In PNAS this week: Cdx2 cells can help regenerate heart tissue in mice following a heart attack, PIWI-interacting small RNA levels in human cancer, and more.