You may find more results for this query on our sister sites: GenomeWeb and Precision Oncology News.
If approved, the new rules for IVDs would take effect in 2022.
The FDA cleared the test to enable clinicians to provide better antibiotic treatment to patients with lower respiratory tract infections or sepsis.
One of the applications seeks premarket approval to run the Vitros immunodiagnostic HIV combo assay on the Vitros 3600 system.
Molecular and point-of-care test revenues are showing promising growth in global diagnostics markets, but immunochemistry tests dominate overall.
The initiative may lead to a test that enables clinicians to determine the presence of bacterial infections within 10 minutes.
The guidance recommends microsatellite instability testing or immunohistochemistry be used to detect abnormalities that may lead to Lynch syndrome.
New minimum performance requirements may reduce the number of misdiagnosed influenza infections, according to the FDA.
The company issued preliminary guidance for 2017 of $260 million to $275 million in revenues and adjusted EPS of between $.17 and $.22.
The firm said it is now an in-network provider with the country's fourth-largest health insurer.
The agency also cleared Roche's assay for diagnosing thyroid or pituitary disorders, as well as tests from Beckman Coulter, Immunostics, and BioMérieux.
The IGRA testing market is ballooning as industrialized nations try to curb the spread of tuberculosis, but the assays still fall short in certain settings and patient populations.
The test from Qiagen was able to identify young children with high interferon-gamma levels who later developed active disease.
The test addresses a major challenge of using an immunoassay for diagnosing Zika — the inability to differentiate it from other flaviviruses.
The company has started a clinical validation study for a PSA test running on the Claros 1 platform and expects to file for a PMA later this year.
The expansion is motivated by increasing market demands and the success of current customer immunoassay development projects.
The firm's medical business sales were down due to the timing of orders placed by distributors.
In 2016, the Korea Centers for Disease Control and Prevention selected the assay to screen individuals at risk of infection through close contact with active TB patients.
The test could be useful to up to 2.2 million patients with chronic HBV to determine whether treatment is working and whether it can be stopped.
The firm is developing an electrochemical sensor platform to detect sepsis and other conditions using a single drop of blood and a single-use cartridge.
Singulex's CEO provided an update at the JP Morgan Healthcare conference on the firm's progress in developing its immunodiagnostics platform.