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 company recently launched an automated microbiology system in its Marlborough, Massachusetts laboratory using instruments from automation firm COPAN.
Beyond its HostDx Sepsis test, the firm is working on a test to detect and differentiate bacterial from viral infections in patients presenting with fever.
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 two companies will work together to bring the point-of-care pretreatment diagnostic based on the XDX-01 biomarker to market in 2020.
The FDA has granted accelerated approval to Rozlytrek as a treatment for adult and adolescent patients with NTRK fusion-positive cancers.
The merger is aimed at expanding Salveo’s diagnostics capabilities and improving communication with providers and patients.