NIH delivered new COVID-19 testing technologies to meet US demand
On Jul. 31, 2020, the National Institutes of Health (NIH) announced that it had invested $248.7 million in…
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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…
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The FDA FDA Issued first Emergency Authorization for sample pooling in diagnostic testing
On Jul. 18, 2020, the U.S. Food and Drug Administration (FDA) reissued an emergency use authorization (EUA) to…
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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…
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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…
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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…
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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…
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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…
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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…
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Biotechnology | COVID-19 | Diagnostics | FDA | Infectious Disease | Medical Device | Non-Profit Research
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…
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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 U.S. Food and…
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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…
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Miami University confirmed high quality of IGEA’s COVID-19 rapid test
On May 5, 2020, IGEA Pharma announced that an evaluation by the University of Miami Miller School of…
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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)…
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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) complied with EU CE requirements, completed the EU declaration of…
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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,…
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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…
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WHO reported “no evidence” that recovered COVID-19 patients cannot be reinfected
On Apr. 25, 2020, the World Health Organization (WHO) reported there was currently ‘no evidence’ that people who…
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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…
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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….
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Todos Medical received medical importer status with U.S. FDA
On Apr. 15, 2020, Todos Medical announced the U.S. Food and Drug Administration (FDA) has accepted Todos Medical’s application…
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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…
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Thermo Fisher Scientific received CE Mark for its Diagnostic test to Detect COVID-19
On Mar. 26, 2020, Thermo Fisher Scientific announced it had received the CE mark in the European Union…
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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…
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Biotechnology | COVID-19 | Diagnostics | FDA | Infectious Disease | NIH
Mesa Biotech received Emergency Use Authorization from FDA for 30 minute point of Care molecular COVID-19 test
On Mar. 24, 2020, Mesa Biotech announced it had received Emergency Use Authorization (EUA) from the U.S. Food…
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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…
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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…
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Biotechnology | COVID-19 | Diagnostics | FDA | Medical Device | Oncology
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…
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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…
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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…
