The diagnostic can now be used to identify a wider range of patients with stage III or metastatic NSCLC who may benefit from first-line treatment with Keytruda.
The test can be used to rapidly and accurately identify patients suffering from heart attacks, and to help identify low-risk patients who may be safely discharged, the firm said.
How labs — including those that are part of other healthcare systems — offering PGx testing will react to Inova's decision to not engage with the FDA remains to be seen.
The test completes a suite of assays designed to detect pathogens that can cause sepsis using the firm's ePlex system.
Qiagen's test is intended to identify advanced bladder cancer patients with alterations in FGFR3 or FGFR2 genes and who are likely to respond to erdafitinib.
The PCR-based Carba assay is designed to detect and differentiate bacterial gene sequences that are associated with resistance to carbapenem antibiotics.
The American Academy of Family Physicians said that the changes being considered by CMS would increase the financial burden on laboratories.
Pharmacogenetics and legal experts took particular issue with the agency's suggestion that "established" drug/gene relationships are found only in FDA-approved drug labels.
The firm is seeking approval of myChoice HRD as a test that can identify ovarian, fallopian, or peritoneal cancer patients deficient in homologous recombination DNA repair.
The clearance by the Chinese NMPA means the instrument can be used as a clinical diagnostic tool in hospitals, laboratories, and clinics in China.
Bluejay's point-of-care test is designed to measure the presence of human immunoglobulin E in a tear sample, providing results within 10 minutes.
The approval advances Chembio’s commercial agreement with Bio-Manguinhos to develop and supply rapid diagnostic tests for Zika, dengue, and chikungunya.
The firm said that its Vitros XT MicroSlides improve lab turnaround time by delivering simultaneous results for pairs of tests that physicians frequently order.
Designed for small and medium-sized labs, the system offers automated blood typing and screening based on gel card technology with minimum user intervention.
The firm said that it is now working toward obtaining the necessary regulatory classification to allow placement of its platelet testing devices in physician offices.
Beckman Coulter got regulatory clearance for three in vitro diagnostic products, including its DxH 520 hematology analyzer for low-volume clinical labs.
The agency said the MediMap tests are in violation of Federal Food, Drug, and Cosmetic Act because they are intended, in part, for use in disease diagnosis.
The FDA cleared the firm's Coag-Sense PT2 second-generation PT/INR monitoring system for professional use in a CLIA setting and by patients at home.
The test is immunoassay-based and detects multiple targets using the firm's automated testing system called the BioPlex 2200.
The FDA said that the final rule is designed to ensure that manufacturers continue to use appropriate practices for Bacillus detection tests.