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Chembio HIV Tests Could Present OTC Competition For OraSure

This article was originally published in The Tan Sheet

Executive Summary

Chembio Diagnostics intends to pursue OTC status for its SURE CHECK HIV 1/2 and HIV 1/2 STAT-PAK rapid tests, the company said upon announcing FDA approval of the two products May 30

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OraSure Plans To File Over-The-Counter HIV Test Application By Year End

OraSure Technologies says it expects this year to complete a pre-market application for its OraQuick Advance Rapid HIV-1 and -2 over-the-counter saliva test. The product would be the first HIV diagnostic intended for use at home and providing results directly to the user.

Chembio HIV test

Chembio announces a new method for performing its HIV 1/2 STAT-PAK Dipstick test during the International AIDS Conference in Toronto, Canada. The new procedure involves placing the test strip on a flat laminate card like a "standard cassette test, yet without the cost and weight of cassette components," the company states in an Aug. 15 release. Customers can still use the original tube procedure as an alternate testing method. Chembio is moving closer toward OTC HIV tests since it filed a CLIA waiver application in July that allows the firm to market its tests to physician offices, clinics and other public health venues. HIV STAT-PAK Dipstick is not yet FDA-approved. Chembio received approval for its SURE CHECK HIV 1/2 and HIV 1/2 STAT-PAK tests in May 1("The Tan Sheet" June 5, 2006, p. 3)...

OraSure Seeks Regulatory Feedback For Marketing Home-Use HIV Test

OraSure Technologies will seek guidance from FDA's Blood Product's Advisory Committee on making its OraQuick Advance oral fluid HIV test available over the counter for use in the home

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