The House Oversight Committee heard about how FDA's devices process may be slowing down the medical devices industry.
The test is being used in clinical trials with Pfizer's crizotinib, an anaplastic lymphoma kinase inhibitor.
The company filed for clearance to run the Aptima Combo. 2.0 assay for chlamydia and gonorrhea on the molecular diagnostic platform.
Garvan Institute will evaluate HealthLinx's prostate cancer biomarkers under one deal, while CPC Clinical Research will liaise with the FDA for HealthLinx's OvPlex test under a separate agreement.
The firm has received pre-IDE evaluations from the FDA for BreastGeneDx and is currently looking for partners to help it during the next stage of assay validation.
In a letter to the company, FDA told Celera that it may have to collect additional data on clinical utility to demonstrate the safety and effectiveness of its KIF6 Genotyping Assay.
Magellan will develop and test an integrated cross-platform software interface for microbial identification gathered on Bruker's MALDI Biotyper and combined with results from Magellan's Sensititre platform.
Enigma's testing platform combines fully automated sample extraction with real-time PCR amplification and detection and is designed to achieve results in less than one hour.
The firm is seeking FDA clearance of its products that are used to collect DNA samples from saliva and for isolating and stabilizing DNA for transport and storage.
The German-based company expects to file its test for FFPE within the next few months, and to start a clinical trial for its cytology test by mid-year.
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.