Genedrive
Top Five Articles on 360Dx Last Week: 510(k) Draft Guidance; EDGC's Early Cancer Testing Plans; More
Last week, readers were most interested in a story about new draft guidance issued by the FDA covering 510(k) clearances.
Genedrive Point-of-Care PGx Test for Stroke Patients Nabs UKCA Mark
The test can determine which stroke patients may respond to clopidogrel treatment in about one hour.
NICE Recommends Genedrive Test in Draft Guidance to Prevent Hearing Loss in Newborns
NICE recommended that Genedrive's MT-RNR1 ID Kit should be adopted by the NHS for the prevention of antibiotic-induced hearing loss.
The institute recently decided to create a new way to evaluate new tests, called the Early Value Assessment program, which has a six-month turnaround time.
UK's NICE to Accelerate Assessment of Genedrive Test
NICE plans to assess Genedrive's MT-RNR1 test for antibiotics-induced hearing loss in infants via a new program.
May 22, 2020
Genedrive Receives CE Mark for SARS-CoV-2 PCR Kit
Nov 21, 2019
Genedrive Receives CE Mark for Hearing Loss Assay
Aug 23, 2019
Jun 19, 2018