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 Aptima HPV assay is the last of five diagnostic products filed by Gen-Probe with the US Food and Drug Administration this year.
ArcticDx's macular degeneration prognostic test officially launched as an LDT in the US in September, and the firm is targeting FDA approval to help propel it globally.
The former commissioner of the FDA has returned to the venture capital firm New Enterprise Associates as a special partner on the healthcare investment team.
Astronauts have edited yeast genes on the International Space Station in an experiment designed to show how cells repair themselves in space.
Emory University has found that two of its researchers failed to divulge they had received funds from China, according to the Atlanta Journal-Constitution.
In Science this week: influence of the nuclear genome on human mitochondrial DNA, and more.