The company has requested a hearing and paid a $20,000 fee to delay its delisting determination until Jan. 9, 2025.

The new Cobas 6800/8800 systems 2.0 enhances throughput and run flexibility and enables sample prioritization.

NEW YORK – The US Attorney's Office for the District of New Jersey said Thursday that the owner of a New York-based consulting firm has pleaded guilty to charges related to a $5.3 million COVID-19 ...

The firm also has plans for tests beyond sepsis, including for cardiac events and other conditions that are commonly treated in acute care settings.

The PD-L1 IHC 28-8 PharmDx test is used to provide information on PD-L1 expression as a biomarker for patient response to therapies containing anti-PD-1 antibodies.

The deal involves the implementation into Limbach Group labs of Noul's automated MiLab instrument that uses microscopy and AI-developed algorithms to analyze samples.

The funding will support the development of the AmplifiDx Dx 100 Platform for use with a nucleic acid amplification test for respiratory infections.

NEW YORK – Altona Diagnostics said on Thursday that it has received the European Union's In Vitro Diagnostic Regulation certification for the company's PCR-based tests, and the company plans to launch ...

The US Food and Drug Administration granted clearances to tests for infectious diseases, drug resistances, and chronic diseases, among other clearances.

The firm said its T2 Magnetic Resonance technology for testing whole-blood samples could be paired with fluorescence and other testing methods.

Last week, readers were most interested in a story about efforts by a new organization to get Congress to pass legislation revamping oversight of LDTs.

The company also recently published multiple new clinical validation studies to support its quest for reimbursement.