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.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

See Also:

"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.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.