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Orasure Technologies CEO Douglas Michels on efforts to get FDA approval of the first over-the-counter HIV test and make it available to consumers by t...
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And FDA advisory panel voting unanimously.
To back a company called or issuers at home HIV test.
Sending shares of the company soaring the most in three years look at this -- some 20%.
But earlier today it rose more than 30% during the intraday trade joining us now -- a fox first on Fox Business interview.
It's Doug -- he is Orasure Technologies CEO.
And president Doug hugely exciting for your company -- what's the next step they've voted unanimously to recommend that regulators say it's okay to put these.
On the shelves no.
No doctors no needed to get one of these so when do we expect to see these tests on the shelf.
Hi -- Thanks for having me on the show today exciting time for Orasure Technologies.
Yesterday you -- the seventeen and up and vote.
Which is a huge vote of confidence for us and then we certainly expect that that will lead to.
FDA approval our next steps are to work with the FDA to take into consideration.
Any recommendations that were made by the advisory committee adjust our labeling for the product that'll go through the approval process with the FDA.
Our hope is that they'll move quickly on this in -- will have and approval sometime later this summer.
Okay later this summer there's the news sometime later this summer this home over the counter HIV test could be available let's talk a little bit about it.
You're -- use some mouth swab correct and you get the results in just twenty minutes how accurate is it -- That's correct list this product was first approved by the FDA in 2002.
And since that time it's been used by health care professionals.
Across the United States and around the world.
It's it's it's been used.
Highly effectively it's a simple quick accurate easy to use its noninvasive test and obviously the accuracy in the hands of a consumer depends really on.
-- how how good the labeling as how good the instructions for use our.
And this has been demonstrated in in the clinical trials that that we conducted and obviously the advisory committee thought yeah.
The product is actually going to be used very safely and effectively in the hands of consumers well.
-- the the significance of this is that you would be making it easier for people to home test one.
There is still stick my at least for some people attached -- their minds that there worried that something.
That the people might look at them differently what have you so this would make it a lot easier for them to anonymously to -- close look at the numbers.
One point two million Americans are infected with the HIV virus.
How many people out there haven't they don't know -- Well that's that's the big issue here and it's estimated somewhere between twenty and 25% of that one point two million people infected.
Are unaware of -- -- and what's significant about that.
Is that those individuals who were -- -- -- are responsible for fifty to 70%.
Of all the forward transmission.
And that's why it's so important to put another tool.
In the marketplace where those individuals have the opportunity to learn their HIV status.
And then of course we're gonna work real hard to -- -- -- to get connected to care the professional version the price is seventeen dollars fifty cents can you give me a price on what the consumer version will be done.
It is now the retailers ultimately -- will set the set the price at retail and we haven't finalized our pricing yet we'll have more to say about that as we get through this process.
With the FDA we get a little bit -- would be more or less than a professional version.
We expect that it'll be more and and obviously that that's supported by the fact that -- have a 24/7 call center ready to support our consumers.
-- obviously the packaging is a bit more involved and we're gonna be promoting this product heavily to raise awareness.
That there is this additional tool available to help everybody know their HIV status.
Listen huge stock day but more important a huge for the health of Americans.
And at least giving them knowledge and power to test for HIV -- Doug Michaels is the CEO Orasure Technologies.
Congratulations we'll see and we'll wait and see if it gets on the shelves by the summer we come back again.
I'd be delighted thanks so much Liz you bet thank you very much -- a --
