HHS' proposed mandatory guidelines for federal workplace drug testing programs include oral fluid as an alternative matrix and allow alternate technologies, such as liquid chromatography-mass spectrometry, for initial drug testing. Among the benefits of oral fluid as an alternative drug testing matrix are its flexibility to meet various drug testing needs in the workplace, ease of collection and reduction of the risk of adulterating a specimen.
First-, second- and third-degree relatives of primary biliary cholangitis patients are at significantly greater risk of developing the disease, according to an Icelandic study in the journal Hepatology. Researchers said development of the disease is likely an interplay between genetic factors and environmental components such as smoking, hormonal factors and urinary tract infections.
Biocept and the University of California at San Diego reached a partnership to conduct a clinical validation study of the company's Target Selector PD-L1 assay in 100 non-small cell lung cancer patients using two antibody clones for programmed death-ligand 1 detection. The Target Selector technology analyzes circulating tumor DNA biomarkers and circulating tumor cell biomarkers from a blood sample, while the PD-L1 assay allows for PD-L1 protein expression detection and monitoring over the course of immuno-oncology treatment.
Foundation Medicine's FoundationOne CDx NGS-based molecular profiling test has obtained approval from the FDA, as well as proposed coverage from the CMS, after it was considered by the agencies under the Parallel Review Program. The test, which allows for the detection of genetic variants in 324 genes and of tumor mutational burden and microsatellite instability in solid tumors, can function as a companion diagnostic to determine which patients with certain mutations are likely to benefit from 15 FDA-approved treatments.
The New York State Department of Health approved Celmatix's Fertilome multigene panel test as a laboratory-developed test. The blood-based assay allows for the analysis of 49 DNA variants in 32 genes linked to polycystic ovarian syndrome, endometriosis and other women's reproductive health conditions.
European regulators gave Vela Diagnostics CE-IVD mark approval for its Sentosa SX Cell-free DNA Kit, which is intended for use in next-generation sequencing and real-time PCR workflows. The kit operates on the Sentosa SX101 instrument and allows for circulating cfDNA extraction from human plasma.
Chembio Diagnostics said it was awarded a contract by the United Nations Children's Fund to supply its point-of-care DPP Zika System, which consists of the Dual Path Platform Zika IgM/IgG Assay and DPP Micro Reader, until Dec. 31, 2019. The $4.9 million contract stipulates a purchase commitment of $1.5 million and potential additional purchases that could be worth up to $3.4 million.
A companion diagnostic development deal was reached by Biocartis and Amgen through which FDA premarket approval will be sought by Biocartis for its Idylla RAS biomarker tests to be used as companion diagnostics for Amgen's metastatic colorectal cancer drug Vectibix. Operational and financial support will be provided by Amgen for the application process; financial terms were undisclosed.