And if the test would work to tell if a guy is hot for a girl, a guy is hot for a guy and a girl is hot for a girl, that would cover all the bases. Orasure would not even need a marketing dept. Word of mouth would do it.
What's telling to me is that Orasure has developed in such a very short time a rapid screening test for Ebola, using blood and saliva, had it successfully used in the field, already received revenues, and is on a fast track for FDA approval. If you add in the other announcements, it looks like the company will be shipping product for commercial use in the next few months. When Michels said at the last conference call that the company would be profitable this year, I think he probably had the news about the Ebola screening test in his back pocket. Now, if management can only perform.
I must say, Orasure is much further along with this Ebola screening test than I imagined. That said, we'll just have to see if Michels' bold predictions bear fruit or not. You may be right. Or, this time, things will be different. Where have I heard that before?
More from same article :
in addition to being used in a health-care facility, the OraQuick test for Ebola can also be performed in the field, which could greatly reduce the lag in getting results. Current Ebola tests, which rely on blood drawn from a person, can take several hours to produce results. But the outcome can sometimes take days because of the time it takes to transport the sample to a lab.
OraQuick also doesn't require refrigeration of samples, which most of the lab-based tests demand, and which is a challenge in poor countries, Michels said.
The OraQuick test may also end up being used on people who have died to determine if Ebola killed them. That application "could be very beneficial" to countries like ones in West Africa where there are traditions of laying hands on the dead to prepare them for burial, Michels said. That practice that has been blamed for increasing the spread of Ebola there because even after death, bodies are highly infectious to those around them.
OraSure expects the FDA to grant the company emergency authorization "in the next month or two" to begin selling the OraQuick Ebola test to governmental organizations that have been fighting the virus as well as to international aid agencies, Michels said. Such authorization would allow the test to be used overseas. Corgenix's ReEBOV received such authorization in March.
Afterward, OraSure will seek FDA approval for sale of the test in the U.S. to doctors or hospitals.
Michels declined to say how much the Ebola test would cost. But OraSure's HIV test, which uses the same technology, sells for $12 per use to health professionals.
Earlier in the year, the Company announced that it had completed the design of a prototype device that appears to deliver analytical performance similar to laboratory PCR tests when evaluated on stored samples from infected patients. During the first quarter of 2015, the Company also recognized revenues from the initial sales of this product to the Centers for Disease Control and Prevention for investigational use in Africa. The data generated from this field testing, along with other clinical and non-clinical studies being performed, is expected to be used in an application to obtain Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) during the next several months.
Hey....Check out today's news. Looks like Doug is onto something.
Here in S.C. not N.C. Not retired. Have a great day!
Here's more detail..
OraSure Technologies, Inc. (OSUR), a leader in point of care diagnostic tests and specimen collection devices, announced today that it has been awarded a contract for up to $10.4 million in total funding from the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response's Biomedical Advanced Research and Development Authority (BARDA) related to the Company's OraQuick(R) Ebola Rapid Antigen Test. The three-year, multi-phased contract includes an initial commitment of $1.8 million and options for up to an additional $8.6 million to fund certain clinical and regulatory activities.
The Company's rapid Ebola test utilizes the OraQuick(R) technology platform which is the same proven technology used in the Company's rapid HIV and HCV test kits.
Uranium Energy Corp is pleased to announce that it has received $3.08 million in cash proceeds from the sale of uranium from inventory. This sale was completed subsequent to the Company's fiscal third quarter ended April 30, 2015, and will be reported in the Company's year-end results for the fiscal year ending July 31, 2015. The sale price of $38.50/lb. is 8.5% higher than the current spot price.
Don't disagree. The FDA often throws up roadblocks too. I would have thought saliva version approval would be a done deal by now.
One of the things holding this stock back,IMO, is the reality that Orasure's Rapid HCV Test is only approved in the U.S. for use on fingerstick and whole blood; not for oral use. On the other hand, the test has CE approval in Europe for oral use. Until the company is able to gain oral use approval in the U.S., the upside on this stock is limited, again in my opinion. When I asked Customer Service at Orasure what the timeline might be for oral approval, the response was "we are working on it."