FDA adds fingerstick sample to roster of COVID EUAs
The FDA has issued an emergency use authorization (EUA) for the first serology test for the SARS-CoV-2 virus that uses a self-collected fingerstick blood sample. The test requires a prescription and the sample must be sent to a lab for processing, but the EUA allows the sample to be processed after the blood sample has dried. The EUA was issued April 6 to Symbiotica Inc., of Vacaville, Calif., which runs the CLIA-certified lab that will process the samples. The sample can be self-collected by users at least 18 years of age, but those younger than that age must have the sample collected by an adult. The company entered into a June 2020 agreement with Intelelabs to develop a test based on an at-home serology test kit.
NICE: Sonata system not backed by head-to-head studies
The U.K. National Institute for Health and Care Excellence (NICE) said the Sonata system by Gynesonics Inc., of Redwood City, Calif., is not backed by evidence for long-term clinical outcomes compared to the standard of care for imaging and treatment of symptomatic uterine fibroids. The device, previously known as the Vizablate, is backed by three prospective single-arm studies that included more than 1,300 patients with uterine fibroids, but those data do not include women who may still be planning to have children. The per-procedure cost is estimated at roughly £2,800 (US$3,870) on an outpatient basis, while inpatient treatment cost runs to £3,400. The average cost of myomectomy (open or laparoscope) or hysterectomy was pegged at more than £3,600. The Sonata avoids the need for general anesthesia, and may hasten a more rapid return to normal activity compared to standard of care. The device is currently used at three centers in the National Health System.