Two New Tests For Aids Virus Approved By Fda One To Show How Fast Patients Will Get Sick

Americans got two new tests for the AIDS virus Monday: one to more easily detect infection and the other to predict how fast patients with the deadly disease will sicken.

The Food and Drug Administration called Epitope Inc.’s Orasure the first oral test that appears as reliable as the standard blood test to diagnose the HIV virus that causes AIDS.

Orasure uses a treated cotton pad to scrape a tissue sample from between the gum and cheek. The sample is tested for antibodies to HIV, and doctors predicted wide use by people at risk for HIV but who shunned blood tests.

Patients who already know they’re infected can find out just how much HIV is floating in their blood with Hoffman-La Roche’s Amplicor test, also approved Monday.

But the question is whether patients will want this test, said Dr. Curtis Scribner, FDA’s deputy director of blood research. Studies do show that patients with high HIV blood levels are more likely to sicken fast - but nobody knows if drugs that lower those blood levels significantly reduce the risk of death or even if changes in HIV amounts signal it’s time to change treatments, he said.

“We are at the cutting edge of science and medicine right here,” Scribner said. “We just have not answered those questions yet.”

Still, Roche will offer baseline Amplicor testing for free to any HIV-infected patient for 60 days starting June 17. Later, the test will cost $150 to $200.

Doctors now gauge AIDS progression by measuring levels of an immune cell called CD4 that is a main target of HIV. But some people have no AIDS symptoms despite very low CD4 levels.

Meanwhile, the first generation of Orasure was approved in 1994, but it used a less sensitive method to screen for HIV antibodies, called the ELISA test.

People who tested positive then had to undergo a more sensitive blood test, called the Western blot, to be sure they had the deadly virus.

But on Monday, the FDA approved a new version of Orasure that allows Western blot testing of the oral sample instead of blood.

Clinical trials showed the Orasure Western blot test was 99.9 percent as accurate as the traditional blood test.

“It’s exactly the same,” said FDA’s Scribner. “Many people don’t like to get stuck for a blood sample, so in this case they could use an oral fluid sample.”