Hologic, Inc. (Hologic or the Company) (Nasdaq: HOLX), a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, announced today that the U.S. Food and Drug Administration (FDA) has approved its Cervista HTA (high throughput automation) system for use with the Company's previously approved Cervista human papillomavirus (HPV) HR test. The Company's HPV HR test utilizes Hologic's proprietary Invader technology to detect 14 high risk types of HPV that are associated with cervical cancer and precancerous lesions. The Company's Cervista HTA system automates the DNA extraction and detection steps of the Hologic Cervista HPV HR test allowing users to walk away after loading the instrument and return the next morning to review the test results.
Despite some assumptions to the contrary, young women who receive recommended vaccinations to prevent human papillomavirus (HPV) infection and associated cancers do not engage in more sexually risky behavior. That is the cautious determination of a national study by The Centers for Disease Control & Prevention reported in the American Journal of Preventive Medicine. Lead study author Nicole C. Liddon, Ph.D. advised against drawing too broad a conclusion from the study, while explaining the motivation behind it. "Because of perceived risk that young women would behave recklessly, parents, providers, policy-makers and other STD opponents raised concerns when the FDA first licensed and approved the HPV vaccine in 2006, " said Liddon. "It was clear that we needed to determine whether a relationship existed between being vaccinated against a sexually-transmitted disease and sexual behavior.
Final results of the POBASCAM trial reveal that for women aged 30+, the human papillomavirus (HPV) DNA test is the optimum cervical cancer screening option. The HPV DNA test prevents more cervical cancers than cytology alone, and detects lesions which cause cervical cancer earlier. Study results provide the strongest evidence to date in favor of using this test in national screening programs. The trial is published Online First in The Lancet Oncology. In an associated comment, Hormuzd Katki and Nicolas Wentzensen from the National Cancer Institute, Bethesda, USA, explain: "POBASCAM reinforces findings from cohort studies, clinical trials, and routine clinical practice by providing overwhelming evidence of the benefits of inclusion of HPV testing in screening programs." Although HPV testing is more precise than cytology at identifying precancerous high-grade cervical lesion, whether it provides greater protection in two screening round over 5 years has not been studied.
HPV DNA testing is better than cytology alone in preventing cervical cancer or detecting it early on for women over thirty, researchers reported in The Lancet Oncology. The authors explained, after reporting on the POBASCAM trial, that they now have compelling evidence in favour of routine HPV testing in national screening programs. In an Accompanying Comment, Hormuzd Katki and Nicolas Wentzensen wrote: "POBASCAM reinforces findings from cohort studies, clinical trials, and routine clinical practice by providing overwhelming evidence of the benefits of inclusion of HPV testing in screening programmes" Experts already knew that HPV testing is better than cytology at identifying precancerous high-grade cervical lesions. However, before this study, nobody could be sure which method of testing was best over a 5-year screening interval.
The Government's plan to switch its Human Papilloma Virus (HPV) vaccination from "Cervarix" to Gardasil" from Sep. 2012, has been welcomed by the British Dental Health Foundation. The leading oral health charity believes that the novel vaccine will deliver increased health benefits and prevent genital warts. In 2010, 75, 000 individuals were diagnosed with genital warts, according to the Health Protection Agency. Already, the vaccination program helps save the lives of approximately 400 individuals with cervical cancer each year. In recent years HPV has been increasingly associated to the increase in mouth cancer cases and neck, genital warts, anal and penile cancers. Last week after following advice from experts in the U.S., the British Dental Health Foundation called for the vaccination program to be extended to boys.