Akonni has received clearance for a molecular diagnostic instrument and a saliva-based pharmacogenomics test for warfarin metabolism.
PATH is using the tool to benchmark RDTs for several diagnostic companies and help them understand if their products are meeting competitive performance standards.
In a tie-up with an asbestos workers' trade union, Owlstone Medical aims to analyze chemicals in the breath of people with historical exposure to asbestos.
The test, called EZ Detect, is a flushable pad that detects the presence of fecal occult blood when dropped into a toilet following a bowel movement.
The study showed that the Zeesan test kit and qPCR instrument could be used for near-patient HPV typing of 94 samples in 2.5 hours.
The resulting company will retain the Lumos name and focus on the international launch of RPS' FebriDx test for febrile acute respiratory infections.
The self-administered test is designed to detect human chorionic gonadotropin levels in women as early as six days before a first missed period.
The company received support from a Johns Hopkins University center focused on point-of-care device development for sexually transmitted infections.
The firms anticipate discovering and validating a biomarker signature, or signatures, for earlier detection of pulmonary hypertension and its subtypes.
After conducting a head-to-head comparison with competing instruments, clinicians selected the Abbott iStat instrument to monitor blood clotting during surgical interventions.
The firm is developing a multipanel test and an antibiotic resistance panel to augment its recently CE marked chlamydia and gonorrhea assay.
The firm reported declines in revenues from its molecular collections systems, genomics products, and infectious disease tests, but still beat analyst estimates.
The direct-to-consumer at-home health testing firm intends to use the funds to expands its platform development and supply logistics in North America.
The firm said it has multiple point-of-care tests available in Brazil and anticipates soon fulfilling an order for its dengue, chikungunya, and Zika tests.
Cincinnati, Ohio-based Meridian will acquire Quebec City-based GenePOC for $120 million, and hopes to quickly convert customers to a PCR-based instrument.
The firm said that its nucleic acid amplification test provides viral load measurements of HIV type 1 groups M/N and O, and HIV-2 within 70 minutes
The company missed the consensus Wall Street estimates on both the top and bottom lines, while its R&D spending and SG&A costs grew significantly.
The firm said that its point-of-care test delivers laboratory-quality results in about 30 minutes and could be used in the home and other settings.
Abbott's test is designed to detect two proteins — GFAP and UCH-L1 — that are released from the brain into the bloodstream following brain injury.
Researchers in Nigeria are developing a handheld diagnostic device for identifying high-risk colorectal cancer patients in low-resource environments.