FDA Clears Genomic Assay
The FDA approved an investigational device exemption for Ignyta’s Trailblaze Pharos assay for use in identifying patients, including those who are treatment-naïve, with solid tumors with NTRK1/2/3, ROS1, or ALK gene rearrangements leading to fusion proteins.
The RNA-based companion diagnostic will be used to determine enrollment eligibility for the STARTRK-2 trial, a global Phase II study evaluating entrectinib in multiple tumors. A laboratory-developed test version was previously used to identify non-treatment-naïve patients who might be eligible for the study.
NICE Gives Nod to HeartFlow Platform
The UK’s price watchdog is backing coverage for HeartFlow’s cardiac imaging platform, which is intended to treat patients with onset chest pain of suspected cardiac origin and a risk for coronary artery disease.
UK’s National Institute of Health and Care Excellence found the device to be cost and clinically effective, noting its diagnostic accuracy and capacity to save patients money on costlier procedures. HeartFlow uses standard coronary computed tomography angiography image data to estimate fractional flow reserve.
Cianna Medical’s Radar Device Cleared
Aliso Viejo, Calif.-based Cianna Medical has secured FDA 510(k) premarket clearance for its radar localization device Savi Scout.
The clearance allows reflectors to be placed at the site of lumpectomy up to 30 days before the surgical procedure.
The device uses infrared light and micro-impulse signals to locate reflectors and assist surgeons with finding target tissue in lumpectomies.
FDA Grants de novo for Concussion Devices
Under a de novo request for classification, the FDA has determined that ImPACT’s concussion devices are substantially equivalent and will be classified as Class II devices under “computerized cognitive assessment aid for concussion.”
The ImPACT is a neurocognitive test batter that measures neurocognitive functioning for managing concussions. The ImPACT pediatric provides similar measurements in children ages 5 to 11.
FDA Alerts Lab Staff on Mass Spectrometers
The FDA is alerting lab staff and healthcare professionals about a software defect in Sciex mass spectrometers. The defect may cause the devices to incorrectly assign results to samples analyzed.
Sciex notified the FDA that, under certain conditions, the defect in the Analyst Software Versions 1.6.1 and 1.6.2, and MultiQuant Software Versions 3.0, 3.0.1, and 3.0.2. may lead the devices to display results that do not match the specimens tested.
Court Invalidates Merck NuvaRing Patent
A federal judge ruled that Merck’s patent for its contraceptive NuvaRing is invalid due to obviousness.
U.S. District Judge Gregory Sleet for the District of Delaware cited a 1995 patent application that disclosed the composition of the two-compartment vaginal ring in his opinion.
Merck has appealed the decision to the U.S. Court of Appeals for the Federal Circuit.