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.
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.
The US Food and Drug Administration granted clearances to tests for infectious diseases, drug resistances, and chronic diseases, among other clearances.
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 firm said its T2 Magnetic Resonance technology for testing whole-blood samples could be paired with fluorescence and other testing methods.
The company also recently published multiple new clinical validation studies to support its quest for reimbursement.
The organization now recommends HPV primary screening every five years starting at age 30 and includes patient-collected HPV screening.
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