Meridian Bioscience (Nasdaq:VIVO) announced today that the FDA re-authorized the emergency use authorization (EUA) for its COVID-19 test. Cincinnati-based Meridian received EUA from the FDA on Nov. 10, 2021, for its Revogene SARS-CoV-2 assay. Following authorization, it was determined that the original design of the assay would not detect the Omicron variant, leading Meridian to […]
Genomics/Molecular Diagnostics
Hologic’s Q3 earnings exceed expectations despite sales slowdown and chip shortage
Hologic (Nasdaq:HOLX) posted third-quarter results today that beat the consensus forecast on Wall Street and increased its outlook for the rest of the year. Marlborough, Massachusetts–based Hologic reported profits of $228.4 million, or $0.90 per share, on sales of $1 billion for the three months ended June 25, 2022. Compared with Q3 2021, profits decreased […]
BD, CerTest launch monkeypox diagnostic for lab research outside the U.S.
BD (NYSE:BDX) and CerTest Biotec announced today that they made their monkeypox virus diagnostic commercially available. The newly developed molecular polymerase chain reaction (PCR) test for monkeypox has been made available outside of the U.S. for use in research applications by laboratories. Franklin Lakes, New Jersey-based BD and Zaragoza, Spain-based CerTest announced a partnership to […]
LumiraDx prices $75.3M offering
LumiraDx (Nasdaq:LMDX) announced today that it priced an underwritten public offering worth approximately $75.3 million. The London-based next-generation point-of-care (POC) diagnostics company is offering 43 million common shares at a price to the public of $1.75 per share. According to a news release, all shares are being offered by LumiraDx, leading to gross proceeds (before […]
Abbott posts Street-beating Q2, raises 2022 guidance
Abbott (NYSE:ABT) shares are down today despite second-quarter results that topped the consensus forecast. The Abbott Park, Illiniois–based company posted profits of more than $2 billion, or $1.14 per share, on sales of $11.3 billion for the three months ended June 30, 2022, for a 69.7% bottom-line gain on sales growth of 10.1%. Adjusted to […]
Sherlock Biosciences appoints new chief commercial officer
Sherlock Biosciences announced today that it appointed Julie Garlikov as its first chief commercial officer. In her role, Garlikov will serve as a member of the point-of-need molecular diagnostic developer’s executive team and will be responsible for driving commercial strategy for the decentralized diagnostics platform. Garlikov will report to Bryan Dechairo, who serves as president […]
Labcorp launches test for detecting neurodegenerative disease
Labcorp (NYSE:LH) announced today that it launched a test that provides direct evidence of neurodegeneration and neuronal injury. Burlington, North Carolina-based Labcorp designed its neurofilament light chain (NfL) blood test to allow doctors to identify and verify signs of neurodegenerative disease, enabling physicians to provide a more effective and efficient path to diagnosis and treatment […]
Hologic launches new assays for COVID-19, flu, RSV in Europe
Hologic (Nasdaq:HOLX) announced today that it now offers its Panther Fusion SARS-CoV-2/Flu A/B/RSV assay and Novodiag test in Europe. Marlborough, Massachusetts-based Hologic designed its Panther Fusion and Novodiag (RESP-4 molecular diagnostic) tests detect and differentiate four of the most prevalent respiratory viruses that can present with similar clinical symptoms in SARS-CoV-2, influenza A and B […]
Visby Medical raises $135M in expanded Series E
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 […]
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 […]