The test MRSA and MSSA directly from blood culture samples in about one hour, compared to between 48 and 72 hours with other methods, the company said.
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.
The NAM, NAS, and Royal Society have formed a commission to develop a framework on the proper use of genome editing, and convened its first meeting in Washington, DC, this week.
Novartis replaced two top executives from its AveXis unit following data manipulation during early testing of its new gene therapy, Reuters reports.
The immune sequencing firm is working on kit-ifying its two existing tests, as well as developing a second clinical test and expanding the label for clonoSeq.
The FDA center of excellence has engaged the technology vendor to incorporate real-world evidence into regulatory decision-making for precision oncology treatments.
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.
US Food and Drug Administration says some data from early testing of Novartis' Zolgensma was manipulated, according to Reuters.
The Wall Street Journal looks into FamilyTreeDNA's handling of genetic genealogy searches by law enforcement.
In a point-counterpoint in the Boston Globe, researchers discuss the potential of gene editing to prevent Lyme disease, but also the pitfalls of doing so.
MIT's Technology Review reports that researchers hope to develop a CRISPR-based pain therapy.
In Science this week: atlas of malaria parasites' gene expression across their life cycles, and more.