The updated guidelines confirm HER2 gene amplification assessed by ISH and protein overexpression assessed by IHC are primary predictors of responsiveness to HER2 therapy.
The expanded clearance includes use of the test to assess a patient's risk of developing diabetes. The assay was cleared to run on the Afinion AS100 Analyzer.
Cigna is the first national private payor to provider coverage for the Decipher tests, which provide a genomic assessment of tumor aggressiveness.
The collaboration will give the company access to UCI research in diagnostic platforms, life science applications, devices, and data analytics.
With the new clearance, DiaSorin's test can be run on genital swabs, and all cutaneous and mucocutaneous swab samples, as well as CSF samples.
The partners will further develop a test to guide clinical care of patients with Plasmodium vivax malaria who may also have G6PD deficiency.
Beckman said that its assay completes the reproductive menu for its Access immunoassay systems and provides better operational efficiency for labs.
Patia will offer the assay, which uses mass spectrometry to measure proteins to predict risk of diabetic kidney disease, as a laboratory-developed test.
The £550,000 award is part of a larger multi-partner grant to develop and implement a point-of-care test to avoid antibiotic-related hearing loss in newborns.
A new company will be established to develop a service platform using blockchain technology for medical services and personalized health management.
A combined assay to screen blood donations for HIV and hepatitis viruses and a test for West Nile virus are now cleared to run on the Procleix Panther system.
In a new guidance, the US regulatory agency encouraged voluntary inclusion of LOINC codes with IVDs as a means to promote data interoperability.
The Belgian cancer center plans to evaluate Natera's ctDNA assay for evaluating response and detecting minimal residual disease in breast cancer patients.
The two-year contract will be used to develop a portable prototype to quickly identify critical infectious pathogens considered threatening to war combatants.
Under a definitive merger agreement, Roche will acquire outstanding shares of Foundation's common stock for $137 per share.
The Fusion module is an in-lab upgrade to Hologic's Panther instrument, which enables labs to extend the testing capabilities of their existing Panther.
The immunofluorescence assays support the detection of anti-double-stranded DNA, which is a marker for systemic lupus erythematosus.
The FDA will consider the companion diagnostic application alongside data for Pfizer's talazoparib in BRCA-mutated advanced breast cancer.
Elizabeth Holmes also stepped down from her position as Theranos CEO on Friday, to be replaced by the company's general counsel David Taylor.
The assay can be used in conjunction with other laboratory and clinical findings to differentiate IBD from irritable bowel syndrome, the firm said.
The UK government aims to create six centers specializing in digital pathology, medical imaging or both, working together through a framework agreement.
With the California licensure, the company’s PCR-based Colvera colorectal cancer monitoring test is available in all US states except New York.
Inspirata plans to leverage Caradigm's software to accelerate the development of Inspirata's cancer big data platform called Cancer Information Data Trust.