FDA approves extended use of Roche’s CINtec PLUS Cytology test

FDA approves extended use of Roche’s CINtec PLUS Cytology test

by Pranali Mehta

Roche Holding AG, one of the leading Swiss multinational healthcare companies, has reportedly announced that it has received approval from the US FDA (Food and Drug Admiration) for the extended use of CINtec® PLUS Cytology test. Based on biomarker technology, it is the first triage test for women whose cervical cancer screening outcomes are positive for high-risk types of HPV (Human Papillomavirus).

As per sources familiar with the knowledge of the matter, additional data from this test aids clinical decisions about which patient will benefit most from immediate follow-up. Laboratories can now efficiently use this test to triage positive outcomes from the cobas® HPV Test run on the fully automated cobas® 6800/8800 Systems.

Speaking on which, Thomas Schinecker, CEO of Roche Diagnostics said that the expanded approval for CINtec PLUS Cytology gives testing laboratories the convenience to triage cobas HPV test outcomes on their choice of cobas® Systems and offer accuracy required to detect HPV infections that could lead to cancer.

Mr. Schinecker added that the biomarker data helps clinicians to clarify the risk of disease, decrease the potential for over or under treatment, and is a pivotal step forward in individualizing a woman’s care.

High-risk human papillomavirus is the main cause of cervical cancer, which is one of the most common cancers women across the globe. The WHO (World Health Organization) has set goals for the nations to proactive steps to eliminate cervical cancer by 2030.

HPV DNA screening efficiently identifies risk for cervical cancer by detecting high-risk human papillomavirus in cervical samples. Although most of the HPV infections resolve naturally, few women who test positive for this virus or who co-testing outcomes are discrepant, may develop or have cancerous cervical lesions. These lesions could lead to cervical cancer if not treated.

Source credit - https://www.globenewswire.com/news-release/2020/09/16/2094233/0/en/Roche-receives-FDA-approval-for-expanded-use-of-the-CINtec-PLUS-Cytology-test-to-aid-clinicians-in-preventing-cervical-cancer.html

Pranali Mehta

A chemical engineer by qualification, Pranali Mehta dutifully walked down the slated path and worked in a chemical firm for a year. Her passion for writing however, pushed her into experimenting with the same as a career. With over three years of experience in content writ Read more...