Decision Diagnostics is facing legal action after the company allegedly misled investors about developing a COVID-19 diagnostic. Licgo Partners, Sovereign Partners and Paradigm Capital, all investor companies, sued Decision Diagnostics and CEO Keith Berman in federal court under allegations that Berman had falsely stated that the company was developing an at-home COVID-19 test that was […]
Genomics/Molecular Diagnostics
Feds charge medical testing company with fraud
A federal grand jury has charged the uBiome co-founders with multiple federal crimes, including two fraud charges, money laundering and more. Now bankrupt, uBiome was founded by Zachary Apte, 36, and Jessica Richman, 46, in 2012 as a medical testing company that performed diagnostic analysis on fecal samples. The company offered a direct-to-consumer service called […]
FDA permits marketing of first COVID-19 diagnostic test through premarket review process
The FDA announced that it granted marketing authorization to Biomérieux subsidiary BioFire Diagnostics for its SARS-CoV-2 (COVID-19) test. Although the test already had emergency use authorization (EUA), the new marketing authorization was granted through the de novo premarket review pathway, marking the first SARS-CoV-2 diagnostic permitted to be marketed beyond the public health emergency, according […]
Roche to acquire GenMark Diagnostics for $1.8B
Roche (SWX: RO, ROG) announced that it entered into an agreement to acquire GenMark Diagnostics (NSDQ:GNMK) for $1.8 billion. Basel, Switzerland-based Roche is set to purchase GenMark at $24.05 per share in an all-cash transaction, totaling approximately $1.8 billion on a fully diluted basis. That represents a premium of approximately 43% to GenMark’s unaffected closing […]
FDA reports problems with Roche combo test for COVID-19 and flu
The FDA released an alert warning of false-positive results with Roche’s (SWX: RO, ROG) Cobas SARS-CoV-2 & Influenza A/B nucleic acid diagnostic. Roche’s Cobas COVID-19/flu combo test runs on its Cobas Liat system. According to an FDA release, the false-positives may be related to two issues observed by the company. The company observed that the assay tubes […]
BD partners with ImageMover for COVID-19 test mobile app
Becton Dickinson (NYSE:BDX) announced today that it entered into an agreement with ImageMover to offer a mobile app for COVID-19 testing. Franklin Lakes, N.J.-based Becton Dickinson’s agreement enables the ImageMover software platform to simplify medical data collection and management through a companion mobile app for SARS-CoV-2 antigen testing performed on the BD Veritor Plus system, […]
Ortho Clinical Diagnostics COVID-19 antibody tests wins CE mark
Ortho Clinical Diagnostics (NSDQ:OCDX) announced today that its new Vitros SARS-CoV-2 antibody assays received CE Mark approval. Raritan, N.J.-based Ortho Clinical Diagnostics’ Vitros anti-SARS-CoV-2 total 2 antibody assay and the Vitros anti-SARS-CoV-2 IgG 2 antibody assay both received European approval for the qualitative and semi-quantitative detection of COVID-19 antibodies, according to a news release. Both […]
First OTC molecular test for COVID-19 gains FDA nod
The FDA today issued its first emergency use authorization for a molecular COVID-19 diagnostic test for at-home use without a prescription. The Cue Health COVID-19 Test for Home and Over The Counter (OTC) use is a molecular nucleic acid amplification test designed to detect genetic material from the SARS-CoV-2 virus in the nostrils. The authorized […]
Abbott wins EUA for COVID-19, flu, RSV combo assay
Abbott (NYSE:ABT) announced today that it received FDA emergency use authorization (EUA) for its Alinity m Resp-4-Plex molecular assay. The laboratory PCR diagnostic is designed to detect and differentiate between SARS-CoV-2 (the virus causing COVID-19), influenza A, influenza B and respiratory syncytial virus (RSV) in one test. It already has CE Mark approval and is […]
Abbott COVID-19 serology test gains EUA
Abbott (NYSE:ABT) this week received FDA emergency use authorization (EUA) for its AdviseDx SARS-CoV-2 IgG II diagnostic — providing another tool to detect people’s adaptive immune response to COVID-19. The serology test from Abbott Park, Ill.-based Abbott is indicated for the qualitative and semi-quantitative detection of IgG antibodies to SARS-CoV-2 — the virus causing COVID-19 […]
Eurofins launches direct-to-consumer home COVID-19 PCR test
Eurofins (Paris:ERF.PA) announced today that it received FDA emergency use authorization (EUA) for its direct-to-consumer COVID-19 test. Luxembourg-based Eurofins’ EmpowerDX at-home COVID-19 nasal PCR test collection kit can be sold directly to consumers without a prescription to aid in testing for SARS-CoV-2, the virus causing COVID-19, according to a news release. Currently, the kit is available […]