NEW YORK – MAWD Laboratories' PCR-based COVID-19 test has received Emergency Use Authorization from the US Food and Drug Administration, according to a notice from the agency posted last week. The ...

Quest Diagnostics named Adrienne Brott its SVP and chief quality and regulatory affairs officer. She will oversee the firm's quality and regulatory strategy, as well as its efforts complying with US ...

NEW YORK – With the US Food and Drug Administration (FDA) likely in coming weeks to release its final rule on regulation of laboratory-developed tests (LDTs), Congress has indicated interest in once ...

NEW YORK — Following extraordinary demand for rapid COVID-19 antigen testing in 2021, Siemens Healthineers reported on Wednesday that the company's fiscal third quarter COVID-19 testing revenue ...

NEW YORK – Virax Biolabs announced on Thursday that it has signed a deal with Cosmos Holdings to distribute Virax's monkeypox PCR tests in Europe. Under the agreement, Cosmos will have exclusive ...

NEW YORK — Dutch molecular diagnostics firm Genome Diagnostics said on Friday that it has received a European Union Quality Management System Certificate under the new In Vitro Diagnostic Medical ...

NEW YORK – With support from the US National Institutes of Health, the Association of Public Health Laboratories is developing infrastructure to collect and distribute results from home COVID-19 tests ...

NEW YORK – Vela Diagnostics said Monday that Japanese clinical testing company SRL will distribute Vela's HIV-1 drug resistance mutation assay kit in Japan. Under the deal, Singapore-based Vela will ...

NEW YORK – Visby Medical announced on Friday that it will execute a $25.5 million contract option with the Office of the Assistant Secretary for Preparedness and Response in the US Department of ...

NEW YORK — Hyris said on Friday that it has received CE-IVD marking for its T-Cell Test for tracking and monitoring T-cell immunity to SARS-CoV-2. The qPCR-based test, which was developed by Mount ...

NEW YORK – This fall the Biden administration released its 2022 Biodefense Strategy and Implementation Plan, laying out its goals for responding to future pandemics and other biological threats. The ...

NEW YORK – In the three years since the start of the COVID-19 pandemic, SARS-CoV-2 testing has garnered the lion's share of attention from the diagnostic industry. But as the demand for and revenues ...