The US Food and Drug Administration (FDA) has granted 510(k) clearance to Switzerland-based diagnostic firm Roche's CINtec Histology test for cervical pre-cancers.
A part of the firm's cervical cancer portfolio, the CINtec Histology is a validated p16 biomarker test designed to confirm the high-grade cervical disease in women who have undergone tissue biopsy.
It provides visual validation of the presence or absence of pre-cancerous lesions when a cervical tissue biopsy is performed during an abnormal cervical cancer screening result.
When used as an adjunct to hematoxylin & eosin (H&E) staining, the test will determine which patient should receive treatment.
Roche Diagnostics chief executive officer Roland Diggelmann said: “The CINtec Histology test will help physicians make informed decisions as to the best course of care for patients with high-grade pre-cancerous cervical disease.
“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 clearance was based on the results from the Cervical Tissue Adjunctive Analysis (CERTAIN) study, ATHENA and PALMS trials which evaluated the effectiveness of Roche cervical cancer portfolio.
The cervical cancer portfolio combines cellular, molecular and tissue-based diagnostic tests to diagnose, screen and manage women.
The portfolio includes the company's cobas HPV test and CINtec PLUS Cytology test, in addition to the CINtec Histology test.
The company noted that the cobas HPV test can be used to screen 12 types of human papillomavirus (HPV) such as HPV16 and HPV18 from one patient sample.
CINtec PLUS Cytology3 test employs dual-biomarker technology to identify p16, Ki-67 and detect transforming HPV infections.