FDA Approved First DNA Test for Two Types of Human Papillomavirus

The U.S. Food and Drug Administration yesterday approved the first DNA test that identifies the two types of human papillomavirus (HPV) that cause the majority of cervical cancers among women in the United States.

The test, called Cervista HPV 16/18, detects the DNA sequences for HPV type 16 and HPV type 18 in cervical cells. Differentiating these HPV types gives health care professionals more information on a patient’s risk of subsequently developing cervical cancer.

A positive Cervista 16/18 test result indicates whether HPV type 16, 18 or both types are present in the cervical sample.

The FDA also approved yesterday the Cervista HPV HR test, which is the second DNA test that detects essentially all of the high-risk HPV types in cervical cell samples. The Cervista HPV HR test uses a method similar to the Cervista HPV 16/18 test to detect the DNA sequences of these HPV types.

In women age 30 and older or women with borderline cytology, the Cervista HPV 16/18 test can be used together with cytology and the Cervista HPV HR test to assess risk of cervical disease.

“Results from these two tests, when considered with a physician’s assessment of the patient’s history, other risk factors, and professional guidelines, can help physicians better determine risk and could lead to better patient management,” said Daniel G. Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health.

HPV is the most common sexually transmitted infection in the United States. The U.S. Centers for Disease Control and Prevention estimates that more than 6 million Americans become infected with genital HPV each year and that more than half of all sexually active women and men become infected at some time in their lives.

For most women, the body's own defense system clears the virus and infected women do not develop related health problems. However, some HPV types can cause cell abnormalities on the lining of the cervix that later can become malignant. While there are many different types of HPV, types 16 and 18 cause about 70 percent of all cervical cancers.

Cervista HPV 16/18 and Cervista HPV HR are manufactured by Madison, Wis.-based Third Wave Technologies.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page

New Uses for Old-Line Diabetes Monitoring Test: Screening and Diagnosis

A blood test currently used as the gold standard for monitoring people already under care for diabetes may have far wider use in identifying millions with undetected diabetes, a team led by a Johns Hopkins physician suggests.

The hemoglobin A1c test (HbA1c), based on a blood sample, is widely used to keep tabs on how well confirmed diabetics keep their blood sugar, or glucose, in check by showing how much glucose red blood cells have been exposed to for the past 120 days, the average lifespan of these cells.

"The test is a measure of long-term glucose control, but doctors don't typically use it to screen for or diagnose the disease, " says Christopher Saudek, M.D., professor of endocrinology and metabolism at the Johns Hopkins University School of Medicine and director of the Johns Hopkins Comprehensive Diabetes Center. "There's reason to believe it could help identify many of the estimated six million people in the U.S. who have diabetes but don't know it," he adds. The current screening and diagnostic tests measure only the amount of sugar present at the moment that blood sample is taken. Consequently, Saudek says, these tests are accurate only if patients fast for at least 10 hours before the test because glucose concentrations can vary greatly depending on a person's recent meals.

Even then, explains Saudek, the tests miss a significant portion of people who have diabetes or are at high risk to develop the disease since glucose also varies depending on a person's diet and exercise regimen for several days leading up to the blood draw.

"If a patient is scheduled for a physical, he or she may 'tune up' by changing their regimen for a few days and throw off their test results, causing doctors to miss the patient's usual pattern of high blood sugar," he says.

In a consensus statement published in the July Journal of Clinical Endocrinology and Metabolism, Saudek and his colleagues conclude that the HbA1c test should be used as a front-line method for identifying patients with diabetes, especially for those at high risk for the disease. Since the test does not require fasting and isn't affected by short-term changes in diet and exercise, the HbA1c test has significant advantages to current testing methods.

The consensus was reached by a group of diabetologists, pathologists and internists seeking to improve detection methods because of the serious consequences of untreated diabetes for patients and public health. They met recently in Chicago with financial support from Metrika Inc., a major manufacturer of diabetes testing equipment. The panel deliberations and manuscript preparation were made independently of the sponsor, according to its members.

After reviewing relevant published studies and available tests, the national panel recommended that individuals who score at least 6 percent on an HbA1c test may have or be at risk for diabetes and should be tracked with additional glucose or HbA1c tests. Those who score between 6.5 percent or above, if confirmed, should be considered to have diabetes.

"This is a first step towards changing medical practice," notes Saudek, and "could greatly enhance how well we're able to identify people with diabetes."

Others who contributed to the consensus statement include William H. Herman of the University of Michigan School of Medicine, David B. Sacks of Brigham & Women's Hospital and Harvard Medical School, Richard M. Bergenstal of the International Diabetes Center, David Edelman of Durham Veterans Administration Medical Center and Duke University, and Mayer B. Davidson of Charles R. Drew University.