The classification indicates a reasonable probability that the use of, or exposure to, a recalled product will cause serious adverse health consequences or death.
The miniature analyzer, which uses disposable cartridges that include all necessary reagents, is designed to provide results from one drop of blood.
Precision Pathology will develop the CyPath Lung test for early-stage detection of lung cancer as an LDT for commercial sale by the first-quarter of 2019.
Questions posed by CMS about expanding PAMA data collection expose a rift between labs and other industry stakeholders over who should report lab prices.
The firm has begun validating its porphyrin molecule marker test for use with flow cytometry at four sites and anticipates adding four, or more, to complete the validation.
The alliance announced earlier this month merges extensive oncology testing services from NeoGenomics with PPD's global CRO capabilities.
The deal begins commercialization of Emosis' first test for heparin-induced thrombocytopenia in at least 36 countries that recognize CE marking.
IncellDx HPV OncoTect 3Dx system combines the quantification of oncogene mRNA overexpression, proliferation, and aneuploidy in one high-throughput assay, according to the firm.
The company said it also saw record cash collections in the quarter despite challenges caused by regulatory change.
The effort could lead to Metafora's flow cytometry-based assay becoming the standard of care for diagnosing the disease in France.