News : clinical

BD Onclarity HPV Assay
The BD self-collection claim for HPV screening has been CE-marked. The new claim allows laboratories and facilities to process self-collected samples via a BD diluent tube using the BD Onclarity™ HPV Assay on either the BD Viper™ LT or the BD COR™ System. more...
Recombinant viral antigen collecting including coronavirus
Sino Biological has developed the world's largest recombinant viral antigen collection, ProVir™, which features an exclusive coronavirus catalog, a comprehensive collection of influenza antigens, and many other hard-to-find viral proteins such as Zika, RSV, Ebola, and Cytomegalovirus. more...
DiaSorin Liason Family Platforms
DiaSorin launches new LIAISON® Murex Anti-HEV IgG & IgM assay for diagnosis of Hepatitis E. This test is the first CLIA fully automated high-throughput solution for the diagnosis of HEV and is available in countries accepting the CE Mark for use on the LIAISON® family platforms. more...
FDA-EUA COVID-19 antigen test for professional and home-test use
The US FDA has granted emergency use authorization to OraSure Technologies to sell its three InteliSwab™ COVID-19 Rapid Tests; for OTC, professional and home-test use. The test requires just one-minute hands on-time and provides a result in 30 minutes. more...
FluoroCycler XT - High performance PCR system for innovative mid-plex LiquidArray assays
Bruker has launched the FluoroType SARS-CoV-2 varID Q assay – a quantitative LiquidArray® mid-plex PCR panel: an assay that detects several important mutations to differentiate many major viral variants routinely on all SARS-CoV-2 positive samples. more...
NGS Panel for SARS-CoV-2 Variants
Thermo Fisher Scientific has launched a new NGS panel for the detection of new and known SARS-CoV-2 variants. The assay is already in use by the International Travel Testing Programme and has played a significant role in discovering emerging VOCs entering the UK. more...
Testing and Passport system launched in Indonesia
Achiko has launched a COVID-19 test booking and passport app in Indonesia, that allows users to book a test, and if negative, receive a green certificate allowing them into busy indoor public areas.   more...
Lepu Medical Publish Statement on FDA Recall
Lepu Medical has issued a statement in response to the recent FDA Class I recall notice of Lepu's COVID-19 antigen and antibody test kits.  more...
Synlab contract testing lab for COVID-19
SYNLAB has been entrusted by UEFA to continue providing PCR-testing for EURO 2020, and for the upcoming football season.  more...
CE-marked COVID-19 Antigen Test
Roche has received CE-marking for its SARS-CoV-2 Antigen Self Test Nasal for rapid self-testing of COVID-19 product. The test provides results in 15 minutes and can be performed in the comfort of your home without any supervision. more...
Kantaro COVID-19 IgG Test
Health Canada has approved the COVID-SeroKlir IgG test from Kantaro Biosciences. The test, which already has FDA-EUA, detects both the presence and precise level of neutralizing IgG antibodies with 98.8% sensitivity and 99.6% specificity and is available immediately.  more...
WHO Naming System for SARS-CoV-2 Variants
The World Health Organization has created a new naming system for SARS-CoV-2 variants of interest (VOI) and variants of concern (VOC). The system will use the letters alpha, beta, and gamma from the Greek alphabet. more...
WHO and Swiss Pathogen Sharing Project
The World Health Organization has set up a biobank facility in Switzerland to store SARS-CoV-2 genomes and enable countries to share biological materials through a central location. The BioHub will expand to other pathogens in the future, other than SARS-CoV-2.  more...
Point-of-care test for SARS-CoV-2 with Low Limit of Detection and FDA-EUA
Qorvo Biotechnologies has entered the SARS-CoV-2 diagnostics market with a point-of-care assay that uses a Bulk Acoustic Wave (BAW) immunosensor detection platform. The test has been granted EUA from the US FDA. more...
FDA warning on Lepu Medical Rapid SARS-CoV-2 Test
The US FDA has issued a warning to the public not to use the Lepu Medical Rapid Antigen Test for SARS-CoV-2. The manufacturer has recalled approx 9 million antibody tests and 250,000 antigen tests.  more...
Coronavirus Literature
Researchers at Stanford University have established a daily-updated AI-powered resource for research literature on SARS-CoV-2, SARS-CoV, and MERS-CoV. The site categorizes the literature into article types and topics such as diagnostics, disease forecasting, and long-COVID. more...
Air sampler for SARS-CoV-2 COVID 19
Smiths Detection has announced that its BioFlash® Biological Identifier has been used successfully in real-world settings at a college campus in Maryland, US. The detector's positive result led to identifying three positive individuals and was also used to deem an area safe to return. more...
Zero-contact medical station for COVID-19 Testing
Brain Navi Biotechnology Co., Ltd has launched a “zero-contact” medical station in hospitals across Taiwan that fully protects medical staff and patients from the cross-infection of “highly contagious diseases,” including COVID-19. more...
POC Combined Flu and SARS Test FDA-EUA
The BD Veritor™ System for the rapid detection of SARS-CoV-2 and Flu A+B has received FDA-EUA and will be launched this summer for the 2021-2022 flu season. The test runs on the handheld BD Veritor™ Plus System and returns a result in about 15 minutes. more...
License CRISPR test for COVID-19
The 221b Foundation, established by Sherlock Biosciences, has announced it has granted several organizations a license to develop and distribute their own COVID-19 tests based on proprietary SHERLOCK technology, with the technology now been used in several continents.  more...
Lateral flow membranes for rapid COVID-19 tests
Merck is expanding its lateral flow membrane manufacturing site in response to global demand for COVID-19 tests. The lateral flow membrane is the key component in rapid diagnostic antigen tests, typically used in tests for infectious diseases like dengue fever, ebola and malaria, and COVID-19. more...
Flu and COVID-19 Vaccine Combo in Pipeline
Novavax has announced positive preclinical data for their combination influenza and COVID-19 vaccine candidate. The combination vaccine elicited robust responses to both influenza A and B and protected against the SARS-CoV-2 virus. more...
Biosurveilance tool for zoonotic disease spillover
Scientists at EcoHealth Alliance, alongside partners at the University of California, Davis and the global PREDICT Consortium, have developed a fully interactive tool that assigns a zoonotic risk score for wildlife-origin viruses, like SARS-CoV-2, Ebola, and endless other newly discovered viruses. more...
Test for West Nile Virus
Pro-Lab Diagnostic’s Pro-AmpRT West Nile Virus Detection Assay has been evaluated for detection of WNV in mosquitoes and birds by the CDC, as well as vector control and public health laboratories. Results available in two hours and have a 100% match with PCR. more...
ViroCell make viral vectors for ATMP clincial trails
ViroCell Biologics aims to be the design and GMP-compliant viral vector creator of choice for corporate and academic cell and gene therapy innovators preparing for and in early-stage clinical trials. ViroCell specializes in batch sizes between 1L to 50L. more...
More virulent pandemic viruses
Lawsuit relates to the approval and issuance of NIH contracts and grants that fund research projects involving controversial gain of function/gain of threat studies with dangerous, so-called "enhanced potential pandemic pathogens." more...
SARS-CoV-2 COVID-19 Variants RT-PCR Test
For research use only (RUO), Bio-rad's SARS-CoV-2 Variant RT-PCR Assays can detect SARS-CoV-2 variants of concern, including P.1, B.1.351, and B.1.1.7, by distinguishing specific mutations in SARS-CoV-2 using RT-PCR often prior to a NGS workflow for confirmation. more...
Recombinant Flu Antigens for vaccines
Sino Biological offers recombinant Flu antigen products under its ProVir® viral antigen collection. The product line covers Hemagglutinin (HA), Neuraminidase (NA), and Nucleoprotein (NP) proteins, from all WHO-recommended vaccine strains in recent years. more...
Molecularly imprinted polymers or synthetic antibodies for rapid antigen tests
The MIP Diagnostics COVID-19 nanoMIP is a synthetic alternative to antibodies that offers ultra-high sensitivity for COVID-19 antigen detecting sensors. Following thorough testing, the nanoMIP has shown an extremely low limit of detection of 5 fg/ml to the RBD spike protein in a sensor device. more...
SARS-CoV-2 RT-qPCR test for Variants
SpeeDx Pty. Ltd. has received CE-IVD marking for its PlexPCR® SARS-CoV-2  assay – a 2-gene test. The high-throughput test is compatible with 96- or 384-well qPCR systems and liquid handling robotics to support a streamlined laboratory workflow and accelerate time to result. more...