OraSure, Abbott, CDC,     American Cancer Society

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Editors Note: There’s increasing pressure for the American healthcare system to deliver improved healthcare out- comes in a cost-effective manner. Not surprisingly, laboratory testing is recognized as a high-impact, low-cost way to accomplish both goals. Here’s a sampling of important healthcare initiatives which emphasize lab testing as essential to higher quality healthcare.

FDA APPROVES 20-MINUTE HIV-1 TEST DEVELOPED BY ORASURE TECHNOLOGIES

HAVING GAINED FDA APPROVAL for its point-of-care HIV test, OraSure Technologies, Inc. announced a co-distribution agreement with Abbott Laboratories that covers the United States.

Called OraQuick® , the test requires a finger stick of whole blood. Clinical data submitted to the FDA indicates that the OraQuick HIV test is 99.6% sensitive and 100% specific. It takes 20 minutes to generate a result. Positive tests must be confirmed using other methodology.

Initial use will be in hospitals and larger health clinics. But its ease of use is such that Health and Human Services Secretary Tommy Thompson has urged OraSure to apply to the FDA for a waiver. AIDS advocacy groups support this move because it would allow the test to be used in more settings, such as in mobile testing vans and at HIV counseling centers staffed by social workers.

Health officials want a rapid HIV test that is simple to use and can generate an immediate and accurate result. Currently at least 8,000 people per year are tested for HIV, but never return to get their results. It is also expected to be useful in many point-of-care situations. For example, women who weren’t checked for HIV earlier in their pregnancy could be tested in the delivery room. This could permit newborns of infected mothers to immediately get HIV-blocking medication.

C-REACTIVE PROTEIN TO PLAY GREATER ROLE IN CARDIOLOGY TESTING

SOON MANY AMERICANS may know as much about their C-reactive protein (CRP) levels as they do about their cholesterol levels. As this happens, laboratories around the country will begin to perform more C-reactive protein testing.

New clinical studies provide evidence that even people with low levels of the “bad” cholesterol LDL may be at higher risk of cardiovascular diseases if their C-reactive protein levels are elevated. Some experts believe that as many as 30 million Americans may have normal LDL levels, but elevated C-reactive protein.

Officials at the Centers for Disease Prevention (CDC) and major cardiology associations are in the process of drafting revised clinical protocols that incorporate CRP testing. These new protocols are expected to trigger major changes to how physicians evaluate patients for heart disease. Laboratorians should track this story as it unfolds.

One clinical study which drew attention to CRP’s role in heart disease was the multi-year Women’s Health Study. Results were published recently in the New England Journal of Medicine. Blood samples from 28,000 women were used to evaluate the relationships between C-reactive protein (CRP) and heart disease. CRP scores below one had the lowest risk. Scores above 3 were highest risk.

“Across the board, CRP proved to be a better predictor (of heart disease) than LDL,” stated Paul M. Ridker, M.D., author of the study and Director of the Center for Cardiovascular Disease Prevention at Brigham and Womens’ Hospital in Boston, Massachusetts.

DIABETES GROUPS PUSH MORE USE OF HBA1C IN EDUCATIONAL EFFORT

IT’S A WELL-ESTABLISHED TEST that’s about to gain a higher profile. Several diabetes associations, with funding from a major pharmaceutical company, have launched a public relations campaign to encourage people to do more HbA1C testing.

The campaign is called “The Diabetes A1C Initiative.” It has two primary goals. The first goal is, over a two- month period, to raise awareness about A1C as a measure of blood sugar control. The second goal is “to educate people about the need for, and benefits of, reaching an A1C less than 7%.” This is the target for proper blood glucose control, as recommended by the American Diabetes Association. Aventis Pharmaceuticals is providing funding for the initiative.

As with heart disease, the numbers are affected people are huge. At least 17 million Americans have diabetes. Another 15 million more are considered to be pre-diabetic—with blood sugar levels above normal, but not yet diabetic.

During the next several years, clinical laboratories should expect to see increased interest by patients in learning more about HbA1C testing. Because of the recommendations of health professionals, the volume of HbA1C testing done annually in the United States will probably also increase.

CANCER SOCIETY ISSUES NEW GUIDELINES FOR PAP TESTING

ON NOVEMBER 14, 2002, the American Cancer Society (ACS) issued new guidelines affecting when and how often women should be screened for cervical cancer. These have been published in the November/December 2002 issue of CA A Cancer Journal for Clinicians.

Based on the new recommendations, most women would begin cervical cancer screening later, have an option to stop at a certain age (70 years), and be exempt from screening entirely if they have had a hysterectomy.

“The new guidelines will have a major impact on the number of women who are over-screened and over-treated,” said Mary A. Simmonds, M.D., President of the ACS. “Because most cervical pre- cancers grow slowly, having a test every two to three years will find almost all cervical pre-cancers and cancers while they can be removed or treated successfully.”

ACS also noted that the big issue in cervical cancer screening is not the sensitivity of existing tests, but reaching women who currently are never tested. “The biggest gain in reducing cervical cancer incidence and mortality would be achieved by increasing screening rates among women who have not been screened or who have not been screened regularly,” observed Dr. Simmonds.

The ACS estimates that 13,000 women will develop invasive cervical cancer this year and some 4,100 women will die of the disease. About half the cervical cancers diagnosed annually in the United States are in women who have never been screened.

The new guidelines also recognize that new cervical cancer screening technologies, like liquid preparation Pap smears and HPV testing, can play a role in early detection.

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