The "drug-tolerant assay" found that only very early TNF levels offered treatment response clues in RA patients treated with the TNF inhibitor adalimumab.
Under new ownership, the immunology and allergy testing laboratory is looking to raise its profile in the US and overseas.
A molecular assay used in combination with patient-collected samples had similar accuracy to testing with clinician collected samples.
The firm's Life Sciences segment grew 10 percent year over year during the quarter while its Diagnostics segment was up 4 percent.
According to researchers, measurement of serum neurofilament light chain levels could aid in early diagnosis and monitoring of the progression of disease.
Researchers combined a new and established biomarker to detect nearly 70 percent of pancreatic cancers with a less than 5 percent false-positive rate.
The immunoassay is designed to detect syphilis treponemal antibodies in primary and secondary syphilis from a single drop of fingerstick blood.
The firm lowered topline and non-GAAP earnings per share guidance for fiscal 2019.
Sienna's in vitro diagnostic is designed to detect the hTERT component of telomerase, a biomarker that aids in the diagnosis of bladder cancer.
The developers are exploring clinical applications with a view to making a platform available in a few years for testing at the point of care and in remote settings.
The guidance advises sponsors to work with the agency to create a development plan for the drug and test early on so they are reviewed and launched around the same time.
Abbott said that the Japanese Red Cross Society selected it as the exclusive supplier of blood and plasma screening serological instrumentation, tests, and consumables.
Roche plans to establish a CAP/CLIA-certified protocol for the assay and PhoenixMD will further refine its precision for identifying patients who may benefit from its RSK2 inhibitor.
The financing will go toward continued development of its MultiPath technology to rapidly identify hospital infections and determine their antibiotic susceptibility.
AllerGenis has the non-exclusive right to use the xMAP technology to develop, market, and sell a precision food allergy diagnostic assay.
GenMark got clearance for an assay to detect fungal pathogens from blood cultures of patients with suspected bloodstream infections, and it received clearance for a bacterial assay.
The decision makes OVA1 available to Cigna's 15 million covered customers and brings the total number of lives covered for the test to 167 million.
QuantiFeron-TB Gold Plus features antigens that measure the cell-mediated immune response to TB infection from both CD4 and CD8 T cells.
The company will provide 1 million rapid diagnostic tests, $750,000, and technical expertise as part of an effort in Odisha to eliminate the disease.
Among the updates provided Wednesday, Quidel's CEO noted the firm's growing presence in point-of-care markets, while PerkinElmer discussed plans for its Vanadis test.