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.
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 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.
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.
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 UK government aims to create six centers specializing in digital pathology, medical imaging or both, working together through a framework agreement.
Inspirata plans to leverage Caradigm's software to accelerate the development of Inspirata's cancer big data platform called Cancer Information Data Trust.
