Hologic Inc. announces pre-market approval for HPV, cervical cancer tests
BEDFORD, Mass. Hologic Inc., a women’s healthcare company, announced Friday that the Food and Drug Administration has approved its premarket approval applications for tests designed to accurately conclude if a patient has human papillomavirus and/or cervical cancer.
Cervista HPV HR, designed to detect the 14 high-risk types of (HPV) known to cause cervical cancer, is the first HPV DNA test approved by the FDA in more than 10 years. Its approved uses include:
- To screen patients with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results to determine the need for referral to colposcopy.
- Used adjunctively with cervical cytology to screen women 30 years and older to assess the presence or absence of high-risk HPV types.
Cervista HPV 16/18 is the first HPV test approved for genotyping for HPV types 16 and 18, known to be associated with approximately 70% of all cervical cancers in the United States. Its approved uses include:
- In women 30 years and older the test may be used adjunctively with the Cervista HPV HR test in combination with cervical cytology to assess the presence or absence of specific high-risk HPV types.
- Used adjunctively with the Cervista HPV HR test in patients with ASC-US cervical cytology results, to assess the presence or absence of specific high-risk HPV types. The results of this test are not intended to prevent women from proceeding to colposcopy.
“We are extremely excited to enter this market with such a unique and strong portfolio of FDA approved molecular tests for HPV DNA,” said Jack Cumming, Hologic chairman, CEO. “Our state-of-the-art Cervista HPV tests individually and in combination are designed to provide significant advantages over the existing technology and should help solidify our leadership in cervical cancer screening.”
Lack of sleep can increase risk of diabetes, study shows
BUFFALO, N.Y. Insufficient sleep every night can increase the risk of diabetes, a new study shows.
Researchers at the University of Buffalo in New York found that people who sleep less than six hours a night are 4.5 times more likely to have elevated blood sugar than those who get six to eight hours of sleep. A fasting glucose level of more than 100 is known as prediabetes.
The researchers presented their findings at the American Heart Association’s 49th annual Conference on Cardiovascular Disease Epidemiology and Prevention.
The findings were based on data from a six-year follow-up of patients who took part in the Western New York Health Study, conducted between 1996 and 2001. The 91 people who started out with normal fasting glucose levels but later developed pre-diabetes were compared to those who maintained normal glucose. The study participants were placed into three groups: those who slept less than six hours, those who slept more than eight hours and those who slept between six and eight hours.
“This study supports growing evidence of the association of inadequate sleep with adverse health issues,” said study lead author Lisa Rafalson. “Genetic susceptibility is always a possible explanation for this finding, but it is more likely that pathways involving hormones and the nervous system are involved in the impared-sleep [and] fasting glucose association.”
PhRMA: White House Healthcare Summit “offers opportunity for input into reform”
WASHINGTON An organization that represents the drug industry said Thursday that the White House’s healthcare summit in Dearborn, Mich., part of a series that will include several cities, “offers opportunity for input into reform.”
“Through a series of White House health reform summits taking place in Dearborn and other cities across the country over the next two months, a diverse group of stakeholders – including patients, physicians, industry, labor and government – will be openly discussing key elements needed in a comprehensive healthcare reform package,” said Billy Tauzin, president, CEO Pharmaceutical Research and Manufacturers of America. “These discussions are critical to help ensure that healthcare reform remains a top national priority this year and does not fall by the wayside.”