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 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 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.
The test will be used to identify which metastatic, castration-resistant prostate cancer patients harbor germline BRCA mutations and will likely benefit from Lynparza.
Filter tips for use with QiaSymphony SP/AS instruments may leak, which could lead to delayed or inaccurate results and cause serious injury or death.
While the FDA has expressed concerns about PGx testing, CEO Erik Hennings said the company has taken measures to limit the risk of consumer harm.
The diagnostic can now be used to identify patients with esophageal squamous cell carcinoma who may benefit from first-line treatment with Keytruda.
The test is designed to detect clinically relevant pathogens and markers of antibiotic resistance from bronchoalveolar lavage specimens.
The letter supporting the LAB Act, which would delay reporting of lab payment data under PAMA, was submitted to the House Energy & Commerce Committee.