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.
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.
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.
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.
