Visby Medical announced today that it added $35 million to an expanded, oversubscribed Series E financing round. San Jose, California–based Visby plans to use the additional investment, which brings its Series E to $135 million in total, to scale production capacity, expand its product menu to include respiratory health tests and anti-microbial resistance panels and […]
Genomics/Molecular Diagnostics
Illumina, Merck launch test for cancer development, progression insights
Illumina (Nasdaq:ILMN) announced today that it launched a new research test, co-developed with Merck (NYSE:MRK). The jointly developed test adds the assessment of a new genomic signature to the already distributed TruSight Oncology 500 assay, enabling researchers to unlock deeper insights about the tumor genome by identifying genetic mutations used in the evaluation of homologous […]
New authorized Roche COVID-19 test can also detect viral loads
Roche announced today that it received FDA emergency use authorization (EUA) for its cobas SARS-CoV-2 Duo diagnostic. Authorization covers the cobas SARS-CoV-2 Duo on the fully automated cobas 6800/8800 systems, expanding Roche’s COVID-19 portfolio and representing the first automated, RT-PCR assay for the in vitro qualitative and quantitative detection of SARS-CoV-2 RNA in nasal and […]
Ibex wins CE mark for AI-powered gastric cancer detection tech
Ibex Medical Analytics announced today that it received CE mark approval for its Galen gastric cancer detection solution. Tel Aviv, Israel-based Ibex uses artificial intelligence (AI) and machine learning technology to power its Galen platform for cancer diagnostics based on hundreds of thousands of image samples scanned from biopsy slides through digital pathology. Galen won […]
BD and CerTest Biotec team up on molecular monkeypox diagnostic test
Becton, Dickinson and Co. and CerTest Biotec announced a partnership to develop a molecular diagnostic test for the monkeypox virus. The CDC is tracking a monkeypox outbreak in the United States and other countries that don’t normally report cases of the infectious virus, which causes a rash and lesions. The virus is mainly shared through […]
Former SCWorx CEO indicted over alleged COVID-19 rapid tests scheme
The U.S. Dept. of Justice announced that Marc Schessel of SCWorx was indicted for charges related to an alleged COVID-19 test scheme. Schessel, the former CEO of the New York-based company, was charged with two counts of securities fraud for his alleged participation in a scheme to mislead investors about SCWorx’s procurement of COVID-19 rapid […]
DoMore Diagnostics wins CE mark for AI algorithm that predicts colorectal cancer outcomes
DoMore Diagnostics announced that it received CE mark approval in Europe for its Histotype Px Colorectal deep learning algorithm. Oslo, Norway-based DoMore designed its Histotype Px Colorectal deep learning algorithm to predict colorectal cancer patient outcomes based on analysis of digital histology images. The company said in a news release that the algorithm, which builds […]
Quidel, Ortho Clinical Diagnostics combine to form in vitro diagnostics company
Quidel (Nasdaq:QDEL) announced today that it completed its $6 billion acquisition of Ortho Clinical Diagnostics (Nasdaq:OCDX). In December 2021, San Diego-based Quidel and Ortho Clinical Diagnostics came to an agreement under which the former would acquire the latter for $24.68 per share of common stock, using a combination of cash and newly issued shares in […]
FDA authorizes Labcorp’s non-prescription COVID-19 test that also detects flu, RSV
The FDA authorized Labcorp’s seasonal respiratory virus RT-PCR DTC test for use without a prescription. Individuals with symptoms of respiratory viral infection consistent with COVID-19 can use the seasonal respiratory virus test that can identify and differentiate multiple respiratory viruses at the same time, which marks the first direct-to-consumer, multi-analyte COVID-19 test authorized by FDA. […]
Lucira Health asks FDA for EUA on molecular at-home COVID/flu test
Lucira Health (Nasdaq: LHDX) today said it has asked the FDA for an emergency use authorization (EUA) for its combination COVID-19 and flu test. Emeryville, California-based Lucira said the at-home test would be available with a prescription to test for SARS-CoV-2, Influenza A and Influenza B. The Nucleic Acid Amplification Test (NAAT) platform has a […]
BD launches automated infectious disease diagnostic platform in the U.S.
BD (NYSE:BDX) announced today that it began the U.S. launch of its new, fully automated, high-throughput diagnostic platform. Franklin Lakes, New Jersey-based BD designed the BD COR MX instrument option, which now has FDA 510(k) clearance, for molecular diagnostics for infectious disease. According to a news release, the first test available on the instrument option […]
