XPhyto pursued market access in Israel for its COVID-19 PCR Rapid Test
On Apr. 28, 2021, XPhyto announce that it has delivered 2,000 of its rapid 25-minute PCR tests (ﾓCovid-ID…
CerTest Biotec, BD announced addition of saliva to CE Marked VIASURE SARS-CoV-2 Real Time PCR Detection Kit for BD MAX
On Apr. 27, 2021, CerTest Biotec, along with BD announced the VIASURE SARS-CoV-2 (N1 + N2) Real Time…
XPhyto signed German distribution, storage and logistics agreement for 25-minute COVID-19 PCR test
On Apr. 21, 2021, XPhyto announced that it had entered into an agreement with an established German pharmaceutical…
Labcorp launched COVID-19 test kits for small businesses to support return to work safely
On Apr. 20, 2021, LabCorp announced the availability of the Pixel by Labcorpï¾® COVID-19 PCR Test Home Collection…
FDA authorized new high-throughput, automated system for leading COVID-19 test
On Apr. 12, 2021, Thermo Fisher Scientific announced that the U.S. Food and Drug Administration (FDA) had granted…
Thermo Fisher Scientific launched In-Air SARS-CoV-2 surveillance solution
On Mar. 24, 2021, Thermo Fisher Scientific announced the launch of the Thermo Scientific AerosolSense Sampler, a new…
XPhyto announces European approval for 25 minute COVID-19 PCR test
On Mar. 18, 2021, XPhyto and 3a-diagnostics announced the European approval of its point-of-care SARS-CoV-2 (COVID-19) RT-PCR test…
XPhyto partner received ISO Certification for 25-minute COVID-19 RT-PCR test
On Mar. 10, 2021, XPhyto and 3a-diagnostics announced successful EN ISO 13485 certification for the rapid point-of-care, SARS-CoV-2…
Agilent completed CE-IVD registration of qRT-PCR In vitro diagnostic kit for SARS-CoV-2 RNA detection
On Mar. 9, 2021, Agilent Technologies announced the launch of a real-time reverse transcription (qRT) PCR-based diagnostic kit…
XPhyto placed first order for 25-minute COVID-19 RT-PCR tests
On Feb. 24, 2021, XPhyto announced that it has placed the first order for its rapid point-of-care SARS-CoV-2…
XPhyto announced completion of European CE-IVD application for 25-Minute COVID-19 RT-PCR test
On Feb. 16, 2021, XPhyto and 3a-diagnostics announced that all actions and procedures required for its European regulatory…
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…
DNA Genotekﾒs OMNIgeneﾮﾷORAL included in EUA granted to Ambry Genetics for use in COVID-19 RT-PCR saliva test
On Jan. 29, 2021, OraSure Technologies announced its OMNIgeneﾮﾷORAL (OM-505) saliva collection kit, a product of subsidiary DNA…
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…
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…
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)…
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,…
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…
FDA authorized first COVID-19 and flu combination test for use with home-collected samples
On Dec. 4, 2020, the FDA authorized the first diagnostic test for at home collection of patient samples…
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…
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…
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…
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…
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…
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…
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 PKampï¾™ 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….