Skip to main content
Premium Trial:

Request an Annual Quote

Roche HPV Test Awarded World Health Organization Prequalification

NEW YORK – Roche announced on Tuesday that it has been awarded World Health Organization Prequalification for an assay to detect human papillomavirus, a leading cause of cervical cancer.

More than 340,000 people globally died of cervical cancer in 2020 and 90 percent of these deaths occurred in low- and middle-income countries, according to the WHO

WHO prequalification expands the availability of the Roche Cobas HPV test in countries that use the WHO prequalification list in making purchasing and implementation decisions, potentially enabling more LMICs to use the test as part of their national cancer screening programs.

"The elimination of cervical cancer is within reach," said Roche Diagnostics CEO Matt Sause. "Roche is committed to working with governments, nonprofit organizations, and funders to help build sustainable cervical cancer elimination programs so that women, no matter where in the world they live, no longer die from this preventable disease."

Prequalification combined with Roche's recently launched CE-marked HPV-self sampling solution further expands access to HPV screening in countries with limited healthcare resources, Sause also said.

The Roche Cobas HPV test detects the high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. It is indicated for use for routine cervical cancer screening, including HPV primary screening, co-testing with cytology, and for triage of women with abnormal cytology to assess the risk for cervical precancer and cancer.

The Cobas HPV test is also part of the Roche Global Access Program, which aims to improve access to cost-effective resources and contribute to the elimination of diseases in the regions with the greatest need.

The Scan

Positive Framing of Genetic Studies Can Spark Mistrust Among Underrepresented Groups

Researchers in Human Genetics and Genomics Advances report that how researchers describe genomic studies may alienate potential participants.

Small Study of Gene Editing to Treat Sickle Cell Disease

In a Novartis-sponsored study in the New England Journal of Medicine, researchers found that a CRISPR-Cas9-based treatment targeting promoters of genes encoding fetal hemoglobin could reduce disease symptoms.

Gut Microbiome Changes Appear in Infants Before They Develop Eczema, Study Finds

Researchers report in mSystems that infants experienced an enrichment in Clostridium sensu stricto 1 and Finegoldia and a depletion of Bacteroides before developing eczema.

Acute Myeloid Leukemia Treatment Specificity Enhanced With Stem Cell Editing

A study in Nature suggests epitope editing in donor stem cells prior to bone marrow transplants can stave off toxicity when targeting acute myeloid leukemia with immunotherapy.