FDA further expanded EUA for Thermo Fisher Scientific’s COVID-19 diagnostic tests
On May 12, 2020, Thermo Fisher Scientific announced the FDA has further expanded emergency use authorization (EUA) for…
Todos Medical entered Into exclusive distribution agreement with Gnomegen and received FDA Emergency Use Authorization for COVID-19 qPCR test kits
On May 11, 2020, Todos Medical announced an exclusive distribution agreement with Gnomegen for the distribution of its…
OPTI Medical Systems received FDA Emergency Use Authorization for OPTI SARS-CoV-2 RNA PCR test kit for detection of Virus causing COVID-19
On May 7, 2020, OPTI Medical Systems, an IDEXX Laboratories subsidiary announced the U.S. Food and Drug Administration…
Miami University confirmed high quality of IGEA’s COVID-19 rapid test
On May 6, 2020, IGEA Pharma announced that an evaluation by the University of Miami Miller School of…
PharmaCyte Biotech received medical devices registration and submited pre-EUA application to the FDA for COVID-19 diagnostic kit
On May 6, 2020, PharmaCyte Biotech announced it had received Medical Devices Establishment Registration with the FDAﾒs Center…
Meridian Bioscience partnered with QuantuMDx on COVID-19 assay
On May 6, 2020, Meridian Bioscience announced a collaboration with QuantuMDx on its newly launched SARS-CoV-2 assay for…
DNA Genotek’s ORAcollect RNA kit included in EUA granted to Biocerna SARS-CoV-2 test
On May 4, 2020, DNA Genotek, a subsidiary of OraSure Technologies, announced that its ORAcollect RNA kit (OR-100)…
Medigen Vaccine Biologics SARS-CoV-2 qPCR kit obtained CE Marking and Taiwan MOHW’s approval of specific medical device’s manufacturing
On Apr. 30, 2020, Medigen Vaccine Biologics (MVB) received notice that its SARS-CoV-2 qPCR Kit had complied with…
Medigen Vaccines SARS-CoV-2 qPCR Kit obtained CE Marking and Taiwan MOHW’s approval
On Apr. 30, 2020, Medigen Vaccine Biologics (MVC) announced its SARS-CoV-2 qPCR Kit complied with EU CE requirements,…
Meridian Bioscience simplified COVID-19 sample prep and eliminated dependence on reagents in short supply
On Apr. 27, 2020, Meridian Bioscience announced the launch of a novel enzyme master mix (Inhibitor Tolerant 1-step…
Biotechnology | COVID-19 | Diagnostics | FDA | Therapeutics
Todos Medical announced FDA Emergency Use Authorization allowed for Gnomegen COVID-19 PCR test kits
On Apr. 21, 2020, Todos Medical announced that Gnomegen has received Emergency Use Authorization from the FDA for…
IDEXX made pet test for COVID-19 Virus available to veterinarians
On Apr. 20, 2020, IDEXX Labs announced the availability of the IDEXX SARS-CoV-2 (COVID-19) RealPCR Test for pets….
Todos Medical received medical importer status with U.S. FDA
On Apr. 15, 2020, Todos Medical announced the FDA has accepted Todos Medical’s application for Medical Device Establishment…
Biotechnology | COVID-19 | Diagnostics | FDA
InBios received EUA for its Smart Detect SARS-CoV-2 rRT-PCR Kit for detection of virus causing COVID-19
On Apr. 8, 2020, InBios announced that it had received Emergency Use Authorization (EUA) from the FDA for…
Thermo Fisher Scientific received CE Mark for its diagnostic test todDetect COVID-19
On Mar. 26, 2020, Thermo Fisher Scientific announced it had received the CE mark in the European Union…
COVID-19 | Diagnostics | FDA
FDA provided Emergency Use Authorization to PerkinElmer for COVID-19 testing
On Mar. 24, 2020, PerkinElmer announced the U.S. Food and Drug Administration (FDA) had provided Emergency Use Authorization…
Mesa Biotech received Emergency Use Authorization from FDA for 30 minute point ofcCare molecular COVID-19 test
On Mar. 24, 2020, Mesa Biotech announced it had received Emergency Use Authorization (EUA) from the FDA for…
BioReference Laboratories and City of Detroit provide testing for Coronavirus disease 2019
On Mar. 23, 2020, BioReference Labs, an OPKO Health company, announced a collaboration with the City of Detroit…
Biotechnology | COVID-19 | Diagnostics | FDA
Quidel received Emergency Use Authorization for molecular COVID-19 diagnostic assay
On Mar. 17, 2020, Quidel Corp. announced it had received Emergency Use Authorization (EUA) from the U.S. Food…
Todos Medical announced Coronavirus Nucleic Acid Buccal Testing Kit distribution agreement with 3D BioMed
On Mar. 17, 2020, Todos Medical announced a non-exclusive distribution agreement with 3D Biomedicine Science & Technology, a…
OpGen updated on Curetis Now Offering BGI’s CE-IVD rapid test kit for Coronavirus in Europe
On Mar. 16, 2020, OpGen reported an update on the business of Curetis, the other party to the…
Leading veterinary diagnostic company saw no COVID-19 cases in pets early in Pandemic
On Mar. 13, 2020, IDEXX Laboratories announced the company had seen no positive results in pets to date…
Luminex provided update on SARS-CoV-2 validation testing efforts
On Mar. 13, 2020, Luminex announced that four independent clinical laboratories had validated laboratory developed tests (LDTs) for…
First of 3 diagnostic tests for SARS-CoV-2 coronavirus available from bioMerieux
On Mar. 11, 2020, bioMerieux announced the forthcoming launch of 3 different tests to address the COVID-19 epidemic…
CerTest Biotec and BD announced COVID-19 diagnostic test
On Mar. 10, 2020, BCerTest Biotec, along with BD (Becton, Dickinson and Company) announced that the VIASURE SARS-CoV-2…
UCSD researchers discovered that a type of DNA-repairing enzyme is neutralized by DNA lesions caused by exposure to ultraviolet light
On Aug. 22, 2018, University of California, San Diego (UCSD) researchers with colleagues in Spain and Finland, described…
Genentech announced a definitive agreement to acquire Seragon Pharmaceuticals
On Jul. 1, 2014, Genentech entered into an agreement to acquire Seragon Pharmaceuticals, a privately held biotechnology company…
Thomas Brock and Hudson Freeze receive the Golden Goose Award
On Sept. 19, 2013, Thomas Brock and Hudson Freeze received the Golden Goose Award for their discovery of…
The CDC received FDA approval for a highly sensitive influenza PCR assay
In 2008, the U.S. Centers for Disease Control and Prevention (CDC) received U.S. Food and Drug Administration (FDA)…
Biotechnology | CDC | Diagnostics | Genomics | Infectious Disease | Therapeutics | Vaccine
The CDC responded to U.S. outbreak of mpox, first human Mpox outside of Africa
On Jul. 8, 2003, the U.S. Centers for Disease Control and Prevention (CDC) responded to U.S. outbreak of…