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Print Edition StoriesFriday, March 13, 2009
Hologic wins FDA OK for two new HPV tests
By Mass High Tech staff
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Medical imaging equipment maker Hologic Inc. has won approval for two of its testing procedures from the U.S. Food and Drug Administration (FDA), representing a couple of firsts for the company.
The Bedford-based Hologic (Nasdaq: HOLX) said the FDA had given it premarket approval for both the Cervista human papillomavirus (HPV) high risk and the Cervista HPV 16 and 18 tests. The Cervista HPV high-risk test detects the 14 high-risk types of human papillomavirus that cause cervical cancer. Hologic claimed this is the first HPV DNA test approved by the FDA in more than 10 years. More specifically, the test is used to screen patients with atypical squamous cells of undetermined significance to decide on the need for referral to colposcopy, a followup for abnormal Pap smears.
On the other hand, Cervista HPV 16 and 18 is the first such test approved for genotyping. These HPV 16 and 18 types are associated with approximately 70 percent of all cervical cancers in the United States. It will be used in women 30 years and older with the Cervista HPV HR test with cervical cytology to determine the presence or absence of specific high-risk HPV types, the company said.
Hologic manufactures diagnostics and surgical products, as well as medical imaging systems designed specifically for women. Hologic’s units concentrate on breast health, diagnostics, GYN surgical and skeletal health
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