Quest Diagnostics (NYSE:DGX) has received an FDA emergency use authorization (EUA) for an at-home diagnostic test for COVID-19. The Secaucus, N.J.-based testing giant said the test kit is for individuals to self-collect a nasal specimen at home or in a healthcare setting when determined to be appropriate by a healthcare provider. It allows an individual to […]
Diagnostics
ArcherDX receives FDA breakthrough device designation for gene sequencing device
ArcherDX recently said it received FDA breakthrough device designation for its next-generation sequencing device. The NGS device is designed as a companion diagnostic to detect neurotrophic receptor tyrosine kinase gene fusions that can lead to the formation and growth of cancer. ArcherDX’s technology uses Multiplex PCR chemistry that captures DNA, RNA or ctDNA from blood […]
Siemens Healthineers to produce 50m antibody tests per month against COVID-19
Siemens Healthineers (ETR: SHL) said today that it has started worldwide shipments of its COVID-19 antibody test, with a goal of producing 50 million tests per month as the pandemic evolves. The German medtech giant also announced that FDA has granted an emergency use authorization for its PCR Fast Track Diagnostics (FTD) SARS-CoV-2 Assay6 test kit. Both […]
Abbott: ID NOW COVID-19 results more accurate with earlier testing
Abbott (NYSE:ABT) said today that its ID NOW COVID-19 test works better on specimens collected soon after patients begin showing symptoms. The test’s performance has drawn fire from federal officials in recent weeks, including a recent FDA warning that the ID NOW test may return false-negative results. The agency granted the test an emergency use authorization […]
Abbott to supply millions of its COVID-19 antibody tests to U.K. government
Abbott (NYSE:ABT) will supply millions of its laboratory-based COVID-19 antibody tests to the U.K.’s National Health Service over the coming months under a contract announced today. The company has already shipped 800,000 of the IgG antibody test to NHS laboratories this week. The news comes on the same day that Abbott said that Health Canada has […]
Mammoth deal with GSK could lead to home COVID-19 test
CRISPR startup Mammoth Biosciences will partner with GlaxoSmithKline’s (NYSE:GSK) consumer healthcare division to develop a home-based diagnostic capable of detecting active SARS-CoV-2, the novel coronavirus that causes COVID-19. The collaboration will use Mammoth Biosciences’ CRISPR-based Detectr platform to design “guide-RNA” that can identify and signal the presence of viral strands obtained through a simple nasal swab, […]
G Medical Innovations ECG Patch receives FDA EUA for use in COVID-19 patients
G Medical Innovations recently announced that it received FDA emergency use authorization for its vital signs monitoring system ECG patch for remote monitoring of patients who are being treated for COVID-19. The patch monitors the QT interval of an ECG in patients to watch for fatal arrhythmias that may occur from treatment drugs. Prolonged QT […]
Bio-Techne, Kantaro Biosciences to produce COVID-19 serology test
Bio-Techne (NSDQ:TECH) and Kantaro Biosciences announced a partnership to manufacture and distribute COVID-19 serology tests. Kantaro, a commercial affiliate of the Mount Sinai Health System in New York, will collaborate with Bio-Techne to develop a test kit based on the Mount Sinai-developed coronavirus test and scale the manufacturing and distribution of those kits. The companies […]
Theranos’ Balwani seeks trial delay, Holmes objects to new charges
Former Theranos president Sunny Balwani has asked a federal judge to postpone his trial on fraud charges until April 2021 and to allow him to renew his passport so he may visit his sick mother in India. Federal prosecutors agreed to the trial postponement, according to a court filing. No indication was given of their […]
Report: PerkinElmer under investigation for Medicare fraud
PerkinElmer (NYSE:PKI) is under federal scrutiny for alleged involvement in a scam to bill Medicare for tens of thousands of unnecessary genetic cancer tests, according to a report by Reuters. The news agency cited three unidentified sources and government documents linking the Waltham, Mass.-based diagnostic and scientific instrument company to the probe. PerkinElmer acknowledged that it has […]
Beckman Coulter awarded expanded contract for sepsis algorithm
Beckman Coulter announced that it received an expanded partnership with BARDA for its expanding COVID-19 medical countermeasure portfolio. BARDA (the Biomedical Advanced Research and Development Authority, part of the U.S. Dept. of Health and Human Services) awarded Beckman Coulter the partnership in collaboration with Dascena, Inc. The collaboration will offer advanced research and development toward […]