Biotechnology | COVID-19 | Diagnostics | FDA
Wren Laboratories launched saliva-based PCR COVID-19 test
On Nov. 12, 2020, Wren Laboratories announced that it had been granted an emergency use authorization by the…
Mesa Biotech received additional $13 million from HHS to develop 30 minute SARS-CoV-2 & Flu A/Flu B test
On Nov. 6, 2020, Mesa Biotech announced it had been awarded a contract up to $13 million from…
PerkinElmer COVID-19 test kit receives FDA Emergency Use Authorization for sample pooling
On Oct. 29, 2020, PerkinElmer announced that the FDA had issued Emergency Use Authorization (EUA) to allow sample…
PerkinElmer received CE Mark for multi-analyte respiratory panel including COVID-19
On Oct. 26, 2020, PerkinElmer announced that its PKamp Respiratory SARS-CoV-2 RT-PCR Panel had received clearance to be…
Todos Medical announced instrument validation completed at MOTO+PARA Mobile Lab
On Oct. 26, 2020, Todos Medical announced the completion of the instrument validation in its mobile lab division….
Todos Medical announced clinical validation and national CLIA certification for MOTO+PARA mobile labs
On Oct. 26, 2020, Todos Medical announced the completion of clinical validation and CLIA certification for MOTO+PARA’s mobile…
Todos Medical announced distribution agreement with Adial Pharma to market Assure/FaStep Covid-19 antibody tests
On Oct. 22, 2020, Todos Medical announced that it had entered into an exclusive supply agreement with U.S….
CerTest Biotec and BD announced CE Mark for combination COVID-19, Influenza, RSV test
On Oct. 21, 2020, CerTest Biotec, along with BD (Becton, Dickinson), announced that the VIASURE SARS-CoV-2 (N1 +…
Sonic Healthcare enhanced test offerings with launch of multiplex assay for COVID-19 and flu
On Oct. 7, 2020, Sonic Healthcare USA announced that it had launched a multiplex RT-PCR assay that combined…
LabCorp COVID-19 molecular test innovation received FDA authorization
On Oct. 2, 2020, LabCorp announced that it had received an Emergency Use Authorization (EUA) from the FDA…
Eiger announced results of investigator sponsored study in outpatients with mild and uncomplicated COVID-19
On Sept. 28, 2020, Eiger BioPharmaceuticals announced results of an investigator sponsored study of Peginterferon Lambda-1a (Lambda) in…
Todos Medical entered Into COVID-19 PCR testing implementation and equipment financing partnership with AID Genomics
On Sept. 25, 2020, Todos Medical announced that it had entered into an implementation and equipment financing partnership…
MIT and the Broad Institute Developed Rapid test for COVID-19 showed improved sensitivity
On Sept. 17, 2020, researchers announced a CRISPR-based test developed at MIT and the Broad Institute that can…
Todos Medical announced commercial launch of COVID-19 qPCR test kits in the U.S.
On Sept. 11, 2020, Todos Medical announced that the FDA has added the TODOS 2019-nCoV RT-qPCR Detection Kit…
Fosun Pharma announced novel Coronavirus (2019-nCoV) RT-PCR detection Kit included in WHO Emergency Use Listing
On Sept. 10, 2020, Shanghai Fosun Pharmaceutical announced that the Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit self-developed by…
Todos Medical announced $23,760,000 contract for COVID-19 PCR testing equipment & supplies with Wisconsin-based laboratory
On Aug. 31, 2020, Todos Medical announced that it had entered into a sales agreement with a Wisconsin-based…
Todos Medical announced $4,500,000 contract for COVID-19 PCR testing equipment & supplies with New York-based laboratory
On Aug. 27, 2020, Todos Medical announced it had entered into a sales agreement with a New York-based…
OpGen announced CE-IVD Mark and commercial launch in EU of molecular diagnostic with PULB for detection of COVID-19
On Aug. 20, 2020, OpGen announced that its subsidiary Curetis GmbH had obtained the CE mark certification in…
Tecan’s automation technology leveraged by Thermo Fisher to scale-up COVID-19 testing globally
On Aug. 5, 2020, the Tecan Group and Thermo Fisher Scientific announced a collaboration to enable scaled-up COVID-19…
Thermo Fisher Scientific’s COVID-19 response expand with new high-throughput automated testing solution
On Aug. 5, 2020,Thermo Fisher Scientific announced a new highly automated, real-time PCR solution designed to analyze up…
PharmaCyte Biotech received CE Mark for licensed COVID-19 molecular tests
On Jul. 29, 2020, PharmaCyte Biotech announced that the COVID-19 Molecular tests it has licensed from Hai Kang…
The FDA FDA Issued first Emergency Authorization for sample pooling in diagnostic testing
On Jul. 18, 2020, the FDA reissued an emergency use authorization (EUA) to Quest Diagnostics to authorize its…
OPKO Health’s BioReference Laboratories reports results of COVID-19 testing for almost one quarter of a million nursing home employees
On Jul. 1, 2020, OPKO Health announced the results of COVID-19 molecular PCR and antibody tests for nursing…
OraSure’s Oragene-Dx included in EUA allowing at-home saliva collection for use with Phosphorus SARS-CoV-2 test
On Jun. 8, 2020, OraSure Technologies announced that Phosphorus Diagnostics, a leader in diagnostic and bioinformatic solutions for…
Abbott released interim clinical study data on ID NOW COVID-19 rapid test showing strong agreement to lab-based molecular PCR tests
On May 21, 2020, Abbott announced an interim analysis of an ongoing multi-site clinical study in urgent care…
Abivax reported ABX464 inhibits replication of SARS-CoV-2 (COVID-19) in reconstituted human respiratory epithelium model
On May 14, 2020 Abivax announced that ABX464 inhibits replication of SARS-CoV-2 in an in vitro reconstituted human…
ABX464 inhibits replication of SARS-CoV-2 (COVID-19) in reconstituted human respiratory epithelium model
On May 14, 2020 Abivax announced that ABX464 inhibited replication of SARS-CoV-2 in an in vitro reconstituted human…
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…