Cue Health’s connected point-of-care Covid-19 test demonstrated 97.8% agreement compared to Central Lab PCR Testing
On Feb. 11, 2021, Cue Health announced the results of an independent clinical validation study conducted by Mayo…
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DNA Genotek’s OMNIgene®·ORAL included in EUA granted to Ambry Genetics for use in COVID-19 RT-PCR saliva test
On Jan. 29, 2021, OraSure Technologies announced its OMNIgene®·ORAL (OM-505) saliva collection kit, a product of subsidiary DNA…
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OraSure’s OMNIgene-ORAL saliva collection kit selected by Chronomics for use in UK Government travel COVID-19 testing
On Jan. 26, 2021, OraSure Technologies announced that Chronomics had selected the OMNIgene-ORAL (OME-505) saliva collection device as…
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Clinical data showed BD antigen test may be more selective in detecting infectious COVID-19 than molecular tests
On Jan. 25, 2021, BD (Becton, Dickinson) announced the publication of a peer-reviewed study that showed BD’s antigen…
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Mesa Biotech received 510(k) clearance and CLIA waiver for Its Accula Strep A Molecular Point of Care Test
On Jan. 19, 2021, Mesa Biotech announced it had received 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA)…
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Twist Bioscience began shipping of synthetic RNA controls for UK variant strain of SARS-CoV-2
On Jan. 14, 2021, Twist Bioscience announced that it had started shipping its new synthetic RNA reference controls,…
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XPhyto completed successful SARS-COV-2 RT-PCR diagnostic testk kit validation
On Dec. 17, 2020, XPhyto Therapeutics and 3a-diagnostics announced the successful validation of their point-of-care SARS-CoV-2 (COVID-19) RT-PCR…
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FDA authorized first COVID-19 and flu combination test for use with home-collected samples
On Dec. 4, 2020, the U.S. Food and Drug Administration (FDA) authorized the first diagnostic test for at home collection…
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Meridian launched air-dryable RT-qPCR mix with reduced costs for COVID-19 test manufacturers
On Dec. 3, 2020, Meridian Bioscience announced that it had launched an Air-Dryable RT-qPCR Mix, driving innovation in…
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Todos Medical completed installation of lab automation equipment at Wisconsin lab for COVID-19 PCR testing
On Nov. 24, 2020, Todos Medical announced that it has completed the installation of Tecan’ laboratory automated equipment…
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Broad Institute rapid COVID-19 test delivered accurate results with minimal equipment
On Nov. 20, 2020, researchers at the Broad Institute of MIT and Harvard announced they had developed a…
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Todos Medical announced positive initial clinical proof-of-concept data for rapid SARS-CoV-2 3CL protease detection assay
On Nov. 18, 2020, Todos Medical announced positive clinical proof of concept data from its lab-based rapid SARS-CoV-2…
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bioMerieux announced CE marking of ARGENE SARS-CoV-2 diagnostic test to include saliva specimens
On Nov. 16, 2020, bioMerieux announced the expansion of its ARGENE range for the detection of SARS-CoV-2. As…
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Aegis Sciences launched combined test for SARS-CoV-2 and influenza A/B virus
On Nov. 16, 2020, Aegis Sciences announced that it had launched a combined test for SARS-CoV-2 and influenza…
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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…
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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…
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Oxford University began COVID-19 test for individuals without symptoms
On Oct. 29, 2020, the University of Oxford announced a new pilot scheme to assess the use of…
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PerkinElmer COVID-19 test kit receives FDA Emergency Use Authorization for sample pooling
On Oct. 29, 2020, PerkinElmer announced that its New Coronavirus Nucleic Acid Detection Kit received Emergency Use Authorization…
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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…
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PerkinElmer Obtains CE Mark For PKamp Respiratory SARS-CoV-2 RT-PCR Panel
On Oct. 26, 2020, PerkinElmer announced that its PKamp Respiratory SARS-CoV-2 RT-PCR Panel had received clearance to be…
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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….
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Todos Medical announced distribution agreement with Adial Pharma to market Assure/FaStep Covid-19 antibody tests
On Oct. 22, 2020, Todos Medical and Adial Pharmaceuticals announced that the companies have entered into a distribution agreement…
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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 +…
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Thermo Fisher Scientific increased availability of COVID-19 testing with sample collection kit from Everlywell
On Oct. 19, 2020, Thermo Fisher Scientific announced it had received an expansion of its Emergency Use Authorization…
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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…
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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 U.S….
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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…
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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…
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Todos Medical announced commercial launch of COVID-19 qPCR test kits in the U.S.
On Sept. 11, 2020, Todos Medical announced that the U.S. Food and Drug Administration (FDA) has added the…
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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…
