Maryland’s Longhorn Vaccines & Diagnostics Set to Launch New Product that Could Revolutionize Molecular Testing

Longhorn Vaccines & Diagnostics, which has offices in Bethesda, Maryland, and San Antonio, Texas, has been at the forefront of the battle against COVID-19. And now, the innovative company has released its latest product, PrimeStore Analyte Transport Media (ATM)Ⓡ, which could revolutionize antigen and molecular testing by completely eliminating the need for RNA and DNA extraction.

In the midst of the company’s remarkable COVID-19 push, where it has sold and distributed approximately 30,000,000 sample collection tubes containing its PrimeStore MTMⓇ product, the company released PrimeStore ATM for purchase in late August 2020 and anticipates filing for U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) in September 2020. 

PrimeStore ATM is a virucidal, bacteriostatic, Guanidine-free sample collection device optimized for molecular testing while providing highly sensitive antigen testing capabilities. The product is validated for influenza qPCR (quantitative polymerase chain reaction) and antigen testing and is the first-of-its-kind extraction-less qPCR sample collection device.

Dr. Luke T. Daum, Longhorn’s Scientific Co-founder, Executive Vice President, and Chief Science Officer, invented PrimeStore ATM and has spearheaded efforts to launch the new product.

“I invented the new product about three years ago to improve and enhance rapid antigen tests for respiratory pathogens…this is a decontaminating blend that destroys lipid-lipid and lipid-protein interactions and yet it preserves protein-protein interactions,” stated Daum. “I wanted ATM to improve antigen testing but we also wanted it to be used as a molecular media. PrimeStore ATM is extremely compatible with Thermo Fisher Scientific’s Magmax System and the Kingfisher platform and improves signal detection compared to other collection media out there.”

“What we’ve found is that a lot of people are using the Magmax chemistry on the Kingfisher platform or other platforms to process COVID-19 samples,” shared Daum. “That was very exciting, but it’s not the most exciting thing we found.”

“What we’ve also found is that with PrimeStore ATM you can do extraction-less PCR, which is the ‘holy grail’ of molecular diagnostics. You can collect a nasopharyngeal swab, stick it in a tube with PrimeStore ATM, vortex the tube and put the sample directly into the machine, skipping the entire middle step of nucleic acid extraction,” shared Daum.

Daum explained that one reason extraction-less PCR is important is that extraction kits and chemistries have been in short supply since the pandemic broke out. Many of the extraction components are sourced from China and other countries and continue to be in short supply. Other benefits of extraction-less PCR are reduced costs and a faster testing process with comparable accuracy. Longhorn has tested PrimeStorm ATM’s extraction-free process against PCR with extraction and PrimeStore ATM has proven equally effective.

EUA from the FDA could pave the way for more companies to use PrimeStore ATM. So far, Longhorn has produced 1,500 liters of PrimeStore ATM and has formed and filled approximately 750K tubes of the medium for sale to labs and other groups that are seeking to validate the product in their respective diagnostic pipelines.  

The coronavirus pandemic has created an unexpected opportunity for Longhorn to not only do tremendous good, but to also find greater success and grow. Longhorn and its team were ready to meet the moment of crisis only because of the company’s long history of diagnostic innovation forged over more than a decade.        

Longhorn is led by world-renown infectious disease researcher Dr. Gerald W. Fischer; his marine-veteran son Jeffrey Fischer is the company’s President. The Fischers are located in the Bethesda, Maryland office. Daum established the San Antonio, Texas office some 13 years ago, after deciding to give up his high-level military position within the U.S. Air Force.

“I earned my PhD through characterization of the influenza genome from soldiers and the  dependents of soldiers around the world. Gerry Fischer visited my lab and I gave him a tour and he slipped me a card and told me to give him a call,” stated Daum. “He eventually talked me into leaving my high-level GS position to start Longhorn. I rolled the dice and it’s worked out great.”

“It was during my experience in the military that I saw how samples were handled in these antiquated viral transport media that were designed to preserve the virus so it could be cultured. Molecular diagnostics changed all that with the evolution of qPCR testing that could give us diagnostic results in a matter of hours. I recognized that while qPCR was advancing and new platforms were coming out, no one was thinking about sample collection,” shared Daum.

While in his lab, Daum saw that thousands of samples that came into his lab often had to be rejected because the cold storage dry ice had melted. In addition, these media were never developed specifically for qPCR and therefore caused problems during testing. 

“I left the military and started looking at viral transport media and what we can do to improve diagnostic testing in the qPCR world,” Daum stated. 

Eventually, Daum and the Longhorn team developed its first product, PrimeStore MTM.  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 while preserving the integrity of RNA/DNA in transit.

PrimeStore MTM helps speed up SARS-CoV-2 testing by simplifying the process and protecting samples from getting compromised and degraded in transit, which was a major bottleneck in the coronavirus testing process in the early phases of the pandemic.

BioBuzz has been following the small, veteran-owned company as it has pivoted from its core multi-drug resistant (MDR) tuberculosis (TB) testing-focus to providing desperately needed COVID-19 diagnostic testing supply kits. PrimeStore MTM was initially FDA cleared for respiratory samples suspected of containing flu or TB and became the first FDA-cleared COVID-19 sample collection kit.

In February 2020, the U.S. Food & Drug Administration (FDA) enlisted Longhorn to increase the production of its PrimeStore MTM product, which was developed in 2006 in preparation for a possible H5N1 global pandemic. In June 2020 USA Today ran a story listing the top companies receiving COVID-19 government contracts. Longhorn landed at #25 on USA Today’s list. 

The company had won, at the time of the USA Today story, $225.8M in government contracts for COVID-19-related work. Since March 2020, when COVID-19 became a stark reality for the globe and the U.S., the company, in partnership with Stanbio EKF and Cenetron, has manufactured approximately 75,000 liters of PrimeStore MTM and has sold and distributed 30,000,000 collection tubes.

“It’s been a total whirlwind. We haven’t had any chance to settle down. My life has revolved around getting our kitting teams and our formulation chemists all the supplies and raw reagents they need to fill tubes,” stated Daum.
With all eyes on BioHealth Capital Region (BHCR) companies developing COVID-19 vaccine candidates, Longhorn Vaccines & Diagnostics’ remarkable year has flown under the radar. With PrimeStore MTM empowering faster and more efficient COVID-19 sample testing, and PrimeStore ATM potentially revolutionizing antigen and PCR testing, years of hard work, perseverance, and innovation are coming to fruition at just the right time for the public and Longhorn’s dedicated, close-knit team.

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