Roche’s histology test gets FDA clearance
April 19, 2017—Roche has received 510(k) clearance from the FDA for the CINtec Histology test. This test, when used in conjunction with hematoxylin and eosin staining, is the only clinically validated p16 biomarker test that helps pathologists determine which women should receive treatment for cervical precancer, the company says.
“The CINtec Histology test will help physicians make informed decisions as to the best course of care for patients with high-grade precancerous cervical disease,” Roland Diggelmann, CEO of Roche Diagnostics, said in a company statement. “By improving the consistency of diagnosis across pathologists, it can help ensure the right patients are receiving the best possible treatment for this highly preventable disease.”
The CINtec Histology test is designed to provide conclusive visual confirmation of the presence or absence of precancerous lesions. It is part of the Roche Cervical Cancer Portfolio and is fully automated on the Ventana BenchMark IHC/ISH instruments.