Roche and its subsidiary TIB Molbiol on Thursday announced that they have developed a COVID-19 polymerase chain reaction (PCR) test that detects and differentiates the latest variant of concern, XBB.1.5.
Cytovale® announced today that its IntelliSep® test has received U.S. Food and Drug Administration 510(k) clearance to aid in the early detection of sepsis for the approximately 30 million adult patients with signs and symptoms of infection who present to US emergency departments each year.
On January 14, Shenzhen YHLO Biotech Co., Ltd. released the 2022 annual performance forecast.
The US Food and Drug Administration recently granted Emergency Use Authorization for Scope Molecular Laboratory's SARS nCoV-2019 Multiplexed Assay for serial COVID-19 testing.
The US Food and Drug Administration said on Tuesday it has granted Emergency Use Authorization for DiaCarta's monkeypox PCR test.
Jiangsu Huadong Medical Device Industrial and Getein Biotech have signed an agreement to jointly manufacture and sell antigen test kits for Covid-19 and other in vitro diagnostics (IVD) products.
Becton, Dickinson and Company (BD) and CerTest Biotec have announced that their molecular assay for detecting the Mpox virus has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA).
Genomic and diagnostic testing company Prenetics Global said Tuesday that the US Food and Drug Administration has cleared ACTOnco, a comprehensive genomic profiling test for solid tumors.
Precision BioLogic said Thursday it secured US Food and Drug Administration 510(k) premarket clearance for its Cryocheck Chromogenic Factor IX test for managing hemophilia B.
Foundation Medicine said Wednesday its FoundationOne Liquid CDx test has received approval from the US Food and Drug Administration as a companion diagnostic for Genentech's Rozlytrek (entrectinib).
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