The Dream of the 90s is Alive at CBER

Wednesday, May 16, 2012

Yesterday's press release announcing a unanimous positive decision from an FDA advisory board for the OraQuik at-home HIV diagnostic device made me tear up a bit. It also made me reflect on just how long change can take.

As many people know, I started my regulatory career in the early 90s at the company that invented the OraSure device. It was a little company near Portland, Oregon called Epitope that was eventually purchased by a company in Bethlahem, PA that is now called OraSure. During the years I was with Epitope we were very focused on making a difference to the HIV epidemic.

Keep in mind these were the years of Philadelphia and Angels in America. An HIV diagnosis was considered a death sentence and people were dying in terrifying numbers. Retrovirals were still early in development and everyone was still pretty skeptical about whether viral load testing was important.

By the mid-90s everyone knew someone that had been affected by the disease. The danger felt real and palpable. Somebody had to do something.

Epitope had a mission and the founders of the company had an idea that we thought could help slow the epidemic. We would find a way to test for antibodies in saliva. It would be an easy collection that a doctor or nurse could do. We optimized the existing EIA and Western Blot that were already used on blood. People could get tested in clinics or even on the street corner.

Though I was just a kid at this time, I was swept up in the mission of the company and even as a beginner felt like I was doing the little I could to help in this world.

One of the many challenges was that not everyone agreed that our idea was a good one – particularly FDA. What would happen when the world heard that you could diagnose HIV by saliva? Would that make everyone assume that you get HIV from saliva? Considerable public education work had been done to assure us that HIV was not a disease of casual contact; would that work be undone by the approval of an HIV spit test? What if patients received a result at home – would the suicide rate jump?

Those and many other public health concerns were put up as barriers to approval even as a device that would be used within the healthcare professional. The public health and technical challenges to consider bringing this to people in their homes were simply extraordinary and could not be surmounted at the time. There were times during the approval process that we all felt like giving up or thought we might have to when the funds were running short.

We eventually received FDA approval for the first version of the device in 1994 and one company, Home Access Health Corp, managed to get an approval on a test that allowed at-home blood collection. The sample has to be sent to a lab and the consumer would call for the result which was accompanied by counseling.

The product isn’t approved yet, but FDA typically follows the advice of their advisory committees. If approved, OraSure will fulfill a dream that has been at least 20 years in the making. A simple way to collect a specimen and test for a deadly disease that can be performed in the privacy of your own home.

It turns out Andy Goldstein and the many other scientists at Epitope did have a good idea. It was simply ahead of its time.

I offer my sincere congratulations to everyone involved with OraSure over the years and to FDA for changing with the times. In particular, I congratulate to the current OraSure team who finally succeeded making our dreams come true. This is a great day for all of us.

Tags: FDA, PMA, Politics

Share / Follow



Other Blog Authors

Dylan Reinhardt
Dave Kern
Steve Gutman
Jo-Ann Gonzales

Recent Blogs

Immediately in Effect Guidance In your role as a regulatory professional, chances are you have faced this situation
A First Look at a New Review Paradigm Working the bugs out of new methods for identifying bugs
FDA Announces New EUO Label Draft guidance will lay out new path for devices
Is Apple's Rumored Healthbook a Medical Device? Looking to re-invent the old "Apple a day" saying