Veteran Owned Diagnostics Supplier Tapped to Help alleviate COVID-19 Sample Collection Shortages
April 28, 2020
Longhorn Vaccines & Diagnostics, located in Bethesda, Maryland, is a privately-held, veteran-run company that develops products for the molecular testing market. Longhorn is currently actively engaged with the FDA, state governments, hospitals, and labs to ramp up testing capabilities across the U.S. and the globe.
In February, the company was enlisted by the FDA to increase the production of its specialized storage tube product. Longhorn has seen a sharp uptick in tube orders over the last several months.
According to Longhorn’s President Jeff Fischer, “In the past 6 weeks, Longhorn has increased production capability of our patented formulation from 50 liters per week to 1,600 liters per week and will be in place to double that in the next two weeks. The 1,600 liters represent over 1 million sample collection tubes per week.
“We currently have tubes and fill finish capabilities to supply about 400,000 tubes a week. In two weeks, we will have the fill finish capacity to exceed 1 million tubes per week, assuming we can receive supply of the necessary tubes,” he added.
These specialized tubes are Longhorn’s PrimeStore® Molecular Transport Medium (MTM) product, which was developed in 2006 in preparation for a possible H5N1 global pandemic. MTM has classified as a De Novo (a brand new device) Class II product cleared by the FDA that is now being deployed for SARS-Cov-2 testing.
“Class II devices are devices that claim specific capabilities, that if they fail to meet the claimed capabilities can put people at risk. In the IVD field, medical tests for individuals are generally class II devices, require significant data and clinical trials, and are FDA cleared. For Class II products to be sold for clinical use, they must show the FDA that they are “substantially equivalent” to another product that the FDA has already given clearance. Emergency Use Authorizations (EUA) are for Class II devices,” stated Fischer.
Class I devices tend to have a lower risk of failure and failure impact is minor. Most Class I products do not go through FDA review and are considered only registered devices.
According to Longhorn, early struggles with testing in China were due to degraded RNA samples. Longhorn’s PrimeStore MTM has demonstrated the ability to fully inactivate viruses in just seconds, stabilizing RNA/DNA for molecular testing and characterization. Because Longhorn’s MTM inactivates the virus, containment, which is mandated by CDC guidelines, is not necessary, and therefore the nasal and oral swab samples stored via PrimeStore MTM can be tested outside of containment facilities. PrimeStore MTM also eliminates the need for “cold chain” shipping.
“PrimeStore MTM was designed to inactivate the pathogens in the sample, release the nucleic acid and stabilize the nucleic acid for shipping with refrigeration. CDC guidance requires potential SARS-CoV-2 samples not inactivated to be handled in a Biological Safety Cabinet. This slows down the processing of samples and reduces the number of laboratories that can provide testing,” stated Fischer.
“It also makes point-of-care testing more difficult or requires the user to take a risk and handle it outside of guidelines. Additionally, samples are supposed to be maintained at 2-8° from the time of collection until they are tested and frozen if the time is to exceed 72 hours,” he added.
Over the last decade, Longhorn has made significant investments in bringing its technology to the fight against tuberculosis (TB). TB, like SARS-CoV-2, is an infectious disease that requires containment processes. TB also disproportionately impacts underdeveloped countries where containment is challenging and where cold shipping costs can be prohibitive or simply not available. Longhorn’s work on TB has laid the groundwork for the remarkable and important contributions it is currently making to expand coronavirus testing capacity.
Longhorn is another great example of a BioHealth Capital Region company that is stepping up to go above and beyond to help fight the COVID-19 crisis.
While Fischer and his team are proud of their COVID-19 efforts, they’re eager to turn their full attention back to TB testing once they’ve done their part to alleviate the coronavirus testing capacity issue.
“In the last year, we have optimized a commercial TB screening test that allows an individual suspected of having TB or at high risk for TB infection to be tested by a non-invasive oral swab. We launched the kit at the end of October 2019 during the 50th annual Union World Conference on Lung Health in Hyderabad, India. Interest was very high, and we were in discussions with several large countries and key Non-Governmental Organizations about further testing and rollout,” said Fischer.
“We look forward to getting back to this important work, as it has the potential to change millions of lives,” he added.
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