|Roche's Cobas HPV test--Courtesy of Roche|
Roche ($RHHBY) won a contract in the Netherlands to provide its HPV test for primary screening of cervical cancer through the country's national cervical cancer screening program, a milestone for the company more than a year after its scored FDA approval for its diagnostic for frontline HPV testing.
The Swiss diagnostics giant beat out other companies for a 5-year contract with the Netherlands' National Institute for Public Health and Environment (RIVM), supplying its test for the country's HPV-based screening program which is expected to start in the second half of 2016, the company said in a statement. Neither side is revealing financial details.
The Netherlands is the first country to roll out a screening program that uses primary HPV screening instead of a Pap test, and the move could set off a trend as more countries weigh the benefits of HPV testing. HPV testing through the program will allow women to go longer between screening visits and let them self-collect their samples, Roche said in a statement, potentially cutting down on time and money.
"The cobas HPV Test was selected by the RIVM because it is supported by all the necessary evidence and data," Roche Diagnostics COO Roland Diggelmann said in a statement. "We believe countries around the world will be looking toward the Netherlands as a potential model for how to best implement HPV primary screening to prevent cervical cancer. We are excited to have been chosen as their partner."
A contract with the Netherlands helps Roche as it expands the reach for its test. In April 2014, the company snagged FDA approval for its cobas HPV test, making it the first diagnostic approved by the agency for frontline testing in women ages 25 and older. The regulatory win came on the heels of a positive FDA panel review, which found that the test was safe for use in women 25 years and older and that its benefits outweigh its risks.
"We are very pleased that the FDA has approved this test for first-line use in cervical cancer screening," Diggelmann said at the time. "We are committed to working with the medical community and professional organizations to put the necessary clinical practice guidelines in place to encourage providers to incorporate this new screening strategy alternative in their patient protocols."
Roche has traveled a long road with its HPV test, scoring FDA approval in 2011 for its diagnostic to screen patients ages 21 and older with abnormal cervical cytology results and to pinpoint the presence or absence of high-risk HPV genotypes in women ages 30 and older. In June 2013 the company filed a submission for a PMA supplement of its test, including three-year registry data from its ATHENA study which screened more than 47,000 women for cervical disease. Results showed that about one in 8 women with normal Pap cytology who were HPV 16-positive had high-grade cervical disease that Pap tests missed, bolstering Roche's case for frontline HPV testing.
- read Roche's statement
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