Focus Diagnostics has announced the FDA 510(k) clearance and CLIA moderate-complexity categorization for its Simplexa Group A Strep Direct Kit....
OPTI Medical Systems, Inc., a subsidiary of IDEXX Laboratories, Inc. announced that it has received the CE mark certification in the European Union for its OPTI SARS-CoV-2 RT-PCR laboratory test kit for the detection of SARS-CoV-2, the virus that causes COVID-19.
Deciphera Pharmaceuticals, Inc. announced that Nature Medicine has published results from a circulating tumor DNA (ctDNA) analysis of the INTRIGUE Phase III study of Qinlock (ripretinib) in GIST patients with mutations in KIT exon 11 and 17/18 only previously treated with imatinib.
Vitagene has announced the availability of 50,000 FDA authorized at home Zero-Contact or Saliva-based COVID-19 test kits for use during the current public emergency to detect COVID-19.
Qiagen announced the immediate launch of its Therascreen PIK3CA RGQ PCR Kit (therascreen PIK3CA Kit) after it received U.S. regulatory...
Kitov Pharmaceuticals has announced that the Phase III, double-blind, placebo-controlled clinical trial for its leading drug candidate, KIT 302 (celecoxib...
Delcath Systems, Inc.announced that the FDA has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for...
BGI Genomics announced that its subsidiary BGI Americas Corporation has received authorization under Interim Order from Health Canada to supply its Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 in the Canadian market.
The FDA has granted 510(k) clearance to InBios� DENV Detect NS1 Elisa Kit, used for detection of the dengue virus...
Virax Biolabs Group Limited an innovative diagnostics company focused on the prevention, detection, and diagnosis of viral diseases, announced that it has entered into an agreement for the distribution of an Avian Influenza A Virus ("AIV") real-time PCR test kit to markets accepting the CE mark, namely the European Union.