The Secret to OraQuick’s FDA Approval

When Orasure received FDA approval for its home-use HIV diagnostic kit earlier this year the medical device industry and Wall Street took notice— with good reason.

The OraQuick In-Home HIV Test represents a critical advance in take-home diagnostics. “It’s the only at-home clinical disease diagnostic on the market," Kathleen Zemlachenko explained to me at AACC's 2012 Annual Meeting, which took place at the LA Convention Center, July 15-19. “Nobody else has anything like it,” said Zemlachenko who is director of marketing at the diagnostic firm.

“The packaging was really key to FDA approval,” —Kathleen Zemlachenko

Approval of the rapid assay device has spelled rapid success for the firm. Within two days of FDA approval, Bloomberg reported that the company had gained 10% value. On July 9, the firm announced proposed public offering of its common stock and on July 12 Canaccord/Genuity named the firm among its favorite stock purchases.

The OraQuick test detects antibodies to HIV-1 and HIV-2 in 20–40 minutes using a swab of the upper and lower gums—previous “at-home” diagnostics for HIV required a finger prick blood sample that was mailed to a laboratory. Orasure’s HIV diagnostic assays have been on the market for 10 years, but this is the first time a product has been designed specifically for at-home use. “We have overwhelming data that show patients are more willing to take an oral test, and more likely to accept the rapid test is over any other [assays] on the market,” Zemlachenko said.

There is no doubt that the technology of the device is a key advance. But the crucial ingredient to making the HIV rapid test available in the home was the company’s masterful packaging design. “The packaging was really key to FDA approval,” Zemlachenko explained. She said that the company went through at least three versions of packaging before they arrived at the final version.

The final version of the Oraquick is rather marvelous. Inside an unassuming box is a thermoformed clamshell package. It contains a flipbook that guides the reader through the testing package, several pamphlets, and 2 foil-wrapped pieces containing the diagnostic. The patient never leaves the package behind during test taking. Thermoformed shelves on the inner lid of the main package hold the diagnostic oral swab upright while the assay runs.

The flipbook provides step-by-step instructions, even including a flap that the user places over the test while it is running. Zemlachenko said that the flap keeps test takers from agnozing over the test while it processes. To help patients keep busy the company also provided educational pamphlets.

After about 20 minutes have passed, the user is instructed to fold back the flap to reveal the results of the assay. Each page of the flipbook and educational literature provides a 24-hour 7-day-a-week helpline.

OraQuick will be on the market by October 2012 and will retail for less than $40, according to Forbes. Zemlachenko said the company has been able to show a 99.94% rate of reliability.

Heather Thompson is editor-in-chief of MD+DI.