Post by icemandios on Mar 20, 2020 12:58:07 GMT
Item 7.01 – Regulation FD Disclosure.
As a result of the COVID-19 pandemic, OraSure Technologies, Inc. has received many questions from customers and researchers about the viability of using its existing medical devices for COVID-19 sample collection. Based on this interest, we are actively engaged with several labs and researchers to demonstrate the effectiveness of our products for this specific use. Recent publications show that the coronavirus can be successfully detected in saliva. However we do not yet have data on samples collected with our devices. We do know that our stabilization solution can accommodate a very broad spectrum of microbiome activity spanning bacteria to viruses.
Although we understand that the current standard for collecting COVID-19 samples is with a nasopharyngeal or oropharyngeal swab, we believe that oral samples collected using devices from our product lines for liquid saliva or oral swab samples could be a suitable alternative. Unlike nasopharyngeal and oropharyngeal swabs which cannot be self-administered, our products are optimized for self-collection.
Moreover, the chemistry in our products stabilizes nucleic acids, including RNA, which is the nucleic acid used by most labs for COVID-19 testing. The usability and form factor of these products are ideal for use in at-home or clinic settings. Should the data support the use of our products for COVID-19 diagnostics, additional avenues of sample collection will be enabled. This includes self-collection, which supports the social distancing guidelines already in place in many communities while reducing the burden on testing sites and healthcare facilities. We expect to receive this data in the near future as this validation requires paired sampling from infected patients.
Aside from potential use cases directly associated with COVID-19, we are also seeing increased demand for our molecular collection products from customers who conduct both saliva and blood-based testing. As it becomes increasingly difficult to collect blood in clinics or healthcare settings, these customers are increasingly relying on the saliva collection alternative, presenting another opportunity for our product lines.
As a result of the COVID-19 pandemic, OraSure Technologies, Inc. has received many questions from customers and researchers about the viability of using its existing medical devices for COVID-19 sample collection. Based on this interest, we are actively engaged with several labs and researchers to demonstrate the effectiveness of our products for this specific use. Recent publications show that the coronavirus can be successfully detected in saliva. However we do not yet have data on samples collected with our devices. We do know that our stabilization solution can accommodate a very broad spectrum of microbiome activity spanning bacteria to viruses.
Although we understand that the current standard for collecting COVID-19 samples is with a nasopharyngeal or oropharyngeal swab, we believe that oral samples collected using devices from our product lines for liquid saliva or oral swab samples could be a suitable alternative. Unlike nasopharyngeal and oropharyngeal swabs which cannot be self-administered, our products are optimized for self-collection.
Moreover, the chemistry in our products stabilizes nucleic acids, including RNA, which is the nucleic acid used by most labs for COVID-19 testing. The usability and form factor of these products are ideal for use in at-home or clinic settings. Should the data support the use of our products for COVID-19 diagnostics, additional avenues of sample collection will be enabled. This includes self-collection, which supports the social distancing guidelines already in place in many communities while reducing the burden on testing sites and healthcare facilities. We expect to receive this data in the near future as this validation requires paired sampling from infected patients.
Aside from potential use cases directly associated with COVID-19, we are also seeing increased demand for our molecular collection products from customers who conduct both saliva and blood-based testing. As it becomes increasingly difficult to collect blood in clinics or healthcare settings, these customers are increasingly relying on the saliva collection alternative, presenting another opportunity for our product lines.
We have also been contacted about R&D work on COVID-19 rapid testing. Specifically, because of our expertise in point-of-care diagnostic devices, we have had discussions with several entities, both domestic and international, regarding the possible development of a rapid point-of-care device to detect coronavirus infection, which could lead to development of rapid, at-home self-tests, having a design and effectiveness similar to our OraQuick® HIV Self-Test. We are continuing to evaluate the best way for us to address this significant unmet need.
[My note: Gottlieb was on CNBC this morning explaining that swabs were going to be a problem. He characterized them as low margin products with few manufacturers as was calling for WWII-like mobilization of manufacturers to increase the supply.
Trump was tested, when asked to give his impression of the process, it said it was not a very nice experience. A swab stuck up your nose to the back of your throat sounds like a recipe for gagging. 
I have anticipated OSUR getting involved for some time now. And home testing is the solution to myriad problems. FWIW