ORASURE GETS CLIA WAIVER



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Last Updated

01 Feb 2003

Source: Wall Street Journal, January 31, 2003

OraSure Gets CLIA Waiver

DOW JONES NEWSWIRES

WASHINGTON -- OraSure Technologies Inc.'s (OSUR) request to extend approval of its rapid HIV test was granted by the Department of Health and Human Services on Friday, just one day after OraSure made the request.

"It was stunning," said OraSure Chief Executive Mike Gausling.

When the OraQuick Rapid HIV-1 antibody test won approval in November, the government allowed only 38,000 certified laboratories to administer the test.

At the time, HHS Secretary Tommy Thompson urged the company to apply for a waiver that would allow the test to be given in 100,000 locations nationwide including clinics, doctor's offices and counseling centers.

Without this waiver, "this test would be limited to use in laboratory settings where many high-risk people do not go for testing," Thompson said in a news release Friday.

The 20-minute HIV test uses a finger stick device similar to the type used by diabetics to test blood sugar.

The rapid results, the government hopes will encourage more people to find out their HIV status. Each year 8,000 HIV-infected people visit public clinics for tests, but do not return the next week to learn the results. The HHS estimates 225,000 Americans are HIV-positive, but don't know it.

OraSure submitted six, one-inch binders to prove the OraQuick test could be given easily and correctly, said Gausling.

To win the waiver, Gausling said, the company had to show that someone with at least a seventh grade education could follow the product's instructions.

In four locations, OraSure pulled 25 people "literally off the street" to administer multiple tests, Gausling said.

Gausling expects OraSure's sales to grow 25% this year, mainly because of the rapid HIV test. The OraQuick will be distributed by both OraSure and Abbott Laboratories (ABT).