FDA Grants Emergency Use for Vela Zika Dx
The FDA issued an Emergency Use Authorization on Sept. 23 for Vela Diagnostics’ Sentosa real-time PCR diagnostic test for detecting the Zika virus.
The Sentosa SA ZIKV RT-PCR Test is a real-time reverse transcription polymerase chain reaction assay for the qualitative detection of RNA from Zika virus in human serum, EDTA plasma, urine and other authorized specimen types.
The Sentosa is the eleventh Zika diagnostic granted emergency use authorization. Read the EUA here: www.fdanews.com/09-27-16-EUA.pdf.
FDA Approves Abbott’s Freestyle Libre Pro
The FDA has approved Abbott’s glucose monitoring system, the FreeStyle Libre Pro device for diabetes.
The device is designed to provide healthcare professionals a visual snapshot of glucose data, which gives a simplified overview of glucose levels and its fluctuating patterns.
Abbott’s FreeStyle Libre Pro system will be available to U.S. healthcare professionals in a few weeks.
FDA Clears Medtronic DBS Software
Medtronic has received FDA marketing clearance for its StealthStation software, which works with Medtronic’s O-arm imaging system to integrate stages of operative plan-imaging during deep-brain stimulation therapy.
Medtronic said the StealthStation software has been used in more than 2.25 million procedures over the last 25 years.
FDA Greenlights Glaucoma Test Device
Eye-device manufacturer Heidelberg Engineering has received marketing clearance for its glaucoma testing device.
New technology in the device allows the module to create an anatomic map unique to each patient’s eye using two fixed, structural landmarks: the center of the fovea and the center of Bruch’s membrane opening.
Quidel Receives Clearance for Influenza Assay
Quidel has received marketing clearance from the FDA for its Solana Influenza A+B assay.
It is designed to detect nucleic acids isolated from nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection.
The diagnostic device is intended for use only with the Solana instrument. The device produces results in under an hour.
Trial Shows Precision Medicine Benefits
A prospective clinical trial showed that establishing a molecular portrait of a cancer patient can improve survival by identifying targetable mutations.
Results showed that 33 percent had improved progression-free survival following a comprehensive genomic analysis, and 62 percent of patients demonstrated disease control, according to researchers at the Gustave Roussy Cancer Campus, which performed the trial. The trial enrolled 1,110 patients with various solid tumors between November 2011 and March 2016, and excluded patients with well-established actionable drug targets.
You can cut it off at “March 2016” if necessary.