- Source : Business Wire
- Date : 2021-07-07
- Event type : Marketed
- Companies : Longhorn Vaccines and Diagnostics LLC, Roche
New Study in the Journal of Applied Laboratory Medicine Supports the Advantages of Longhorn's PrimeStore MTM With the Roche Cobas Liat System for SARS-CoV-2 and Influenza Detection
Study validates PrimeStore Molecular Transport Medium® for use with respiratory collection of clinical oral and nasopharyngeal swabs on Roche's point-of-care cobas® Liat® System
BETHESDA, Md.--(BUSINESS WIRE)--Longhorn Vaccines & Diagnostics, a privately held biotechnology company developing molecular-based collection and testing reagents, today announced milestone study results in The Journal of Applied Laboratory Medicine from the American Association for Clinical Chemistry (Oxford Academia). The research article, “Rapid and Safe Detection of SARS-CoV-2 and Influenza Virus RNA Using Onsite qPCR Diagnostic Testing from Clinical Specimens Collected in Molecular Transport Medium,” is the first published study to bridge the PrimeStore Molecular Transport Medium® (MTM), an FDA cleared collection device, with Roche's cobas Liat®, a point-of-care FDA approved diagnostic system for simultaneous detection of SARS-CoV-2 (COVID-19) and influenza A/B viruses.
For SARS-CoV-2 and influenza A/B viruses, the necessity for safe sample testing, which includes RNA/DNA inactivation, is important to preserve the dignity of each sample and to ensure lab technicians are handling secure transport tools. Since clinical swabs are inactivated and RNA/DNA is preserved in PrimeStore MTM®, processing and running patient samples on the Roche Liat® System provides a safe alternative to commercial viral/universal transport medium, particularly at urgent care clinics and doctor's offices for near-patient care.
“In this study, we demonstrated that clinical Nasal Pharyngeal and oral swabs, collected via PrimeStore MTM® and tested by standard qPCR using CDC tests, were equivalent to those assessed by Roche's Liat System,” said Luke T. Daum, Ph.D., Chief Scientific Officer of Longhorn and lead author on the paper. “Safely inactivating microbes in PrimeStore MTM® vials is important for physicians and healthcare staff who routinely handle, uncap, and transfer patient samples into Liat® cartridges prior to testing.”
Gerald W. Fischer, M.D., Chief Medical Officer of Longhorn added: “Since the clinical presentation of influenza and COVID-19 can be very similar, it is important that health care providers have highly accurate on-site testing platforms like the Roche Liat® to determine the cause of illness and be able to provide rapid and appropriate treatment. Inactivating the sample at collection provides an added safety layer to the healthcare team.”
To read the full study, access the research on The Journal of Applied Laboratory Medicine: https://academic.oup.com/jalm/advance-article/doi/10.1093/jalm/jfab073/6307725?guestAccessKey=2e4f306d-e10c-4c15-8b2f-b6cf81977ba6
About PrimeStore MTM
PrimeStore MTM (Molecule Transport Medium) was the first microbial nucleic acid storage and transport device cleared by the U.S. Food and Drug Administration (U.S. FDA). It is indicated to rapidly inactivate viruses (including Influenza), bacteria (including Mycobacterium tuberculosis) and high consequence veterinary pathogens (including ASFv, CSFv, FMDv, HPAI, NDv) within the sample and stabilize the RNA and DNA to provide safer and more efficient workflow for molecular testing and sequencing.
PrimeStore MTM alleviates the challenge of collecting a quality sample and transporting it in a safe and timely manner to any laboratory that can effectively test that sample using modern molecular platforms. Researchers worldwide have used the device successfully, including in remote regions of Nepal, India, China, South Africa, Peru, Pakistan, Papua New Guinea, and Ukraine, as well as densely populated cities such as Mumbai, Pretoria, Macau and Singapore.
PrimeStore MTM has multiple issued patents in the United States and worldwide.
About Longhorn Vaccines and Diagnostics
Longhorn Vaccines & Diagnostics is an innovative molecular tool, assay and vaccine development company focused on serving unmet critical needs in both developed and developing nations. Longhorn's core product, PrimeStore® Molecular Transport Medium (MTM), is a patented, FDA approved, state-of-the-art ambient temperature molecular diagnostic collection and transport device that can help governments, global health organizations and drug manufacturers improve the diagnosis and treatment of highly infectious diseases such as Influenza, SARS-CoV-2, and Mycobacterium tuberculosis (TB). Unlike standard devices for collecting and transporting TB samples, PrimeStore® MTM is the first molecular transport device that can safely deactivate pathogens and stabilize RNA and DNA, allowing enhanced point of care and ambient temperature transport for laboratory based molecular testing and characterization. Longhorn is based in Bethesda, Maryland with a diagnostic research and development facility in San Antonio, TX.