The blood test screens individual blood donations for four common species of the parasite Babesia, which can cause anemia and other potentially fatal conditions.
The industry organization issued a letter urging the agency to reconsider recent decisions to demand several laboratories stop offering pharmacogenetic testing.
The test detects 20 common viruses and bacteria that cause upper respiratory infections using the firm's high-throughput, automated MDx-3000 instrument.
An analysis in JAMA Network Open examines regulatory approvals not based on randomized clinical trials.
Janet Woodcock, the director of the Center for Drug Evaluation and Research at the US Food and Drug Administration, says changes are needed for all benefit from biomedical advances.
The group notes the importance of lab CLIA certification, clear test reports, and clinical validity support for test claims in the literature, guidelines, and FDA labels.
The clearance of the Binx io CT/NG test marks a milestone for the Johns Hopkins University group that funds early-stage development of rapid STI testing.
The US Food and Drug Administration has asked questions about Myriad Genetics' GeneSight test, according to Bloomberg.
The FDA has granted accelerated approval to Rozlytrek as a treatment for adult and adolescent patients with NTRK fusion-positive cancers.
Industry players, faced with vague communications from the agency, scramble to decipher regulatory expectations and criticize the agency for trying to control PGx knowledge.
According to Gizmodo, researchers have developed a list of a million nucleic acid-like polymers that could store genetic information.
An opinion piece in the Washington Post argues that golden rice could save the sight and lives of many children.
US National Institutes of Health has issued a new draft data-sharing policy, ScienceInsider reports.
In Cell this week: analysis of immune microenvironment in hepatocellular carcinoma, proteogenomic analysis of clear cell renal cell carcinoma, and more.