Positive data published in the International Journal of Tuberculosis and Lung Disease demonstrate use of PrimeStore Molecular Transport Medium can increase access to tuberculosis testing and reduce time to diagnosis and life-saving treatment.
Bethesda, MD and Gaithersburg, MD, August 22, 2023 – Longhorn Vaccines and Diagnostics LLC, a One Health company developing vaccines and diagnostic tools for global public health and zoonosis concerns, announced today new data validating the company’s core diagnostic product, PrimeStore® Molecular Transport Medium (MTM), and its potential to increase access to Mycobacterium tuberculosis (TB) testing for children in remote and underserved areas and reduce time to diagnosis and initiation of life-saving treatment . The data were published in a recent edition of the peer-reviewed International Journal of Tuberculosis and Lung Disease (IJTLD).
Globally, an estimated one million children develop TB annually, mostly in low-income countries. Testing is essential to early interventional treatment, so the use of stool swabs in molecular transport media was examined as a non-invasive, cost-effective and safe testing method. The study, titled “Use of stool swabs in molecular transport media increases access to Xpert Ultra testing for TB in children,” found:
- Stool samples collected using Longhorn’s PS-MTM gave results highly concordant with results using the World Health Organization-endorsed Simple-One-Step (SOS) stool method and the gold standard gastric aspirate (GA) which requires an invasive collection procedure.
- PS-MTM inactivates TB and stabilizes DNA without refrigerated sample transport, which eliminates the need for cold-chain transport and storage. Samples collected by other methods degrade quickly, especially at elevated temperatures.
- Use of PS-MTM for stool has the potential to increase access to TB diagnoses and improved outcomes for children in areas without a sophisticated healthcare infrastructure, such as Zambia, where the study was conducted.
“This study further validates just how valuable the PrimeStore MTM diagnostic approach is at identifying TB and other seasonal, endemic and pandemic diseases,” said Longhorn Vaccines & Diagnostics CEO Gerald W. Fischer, MD. “The traditional method of testing children for TB involves collecting sputum, which is considered invasive. Non-invasive, accurate, efficient and accessible diagnostic testing is the key to mitigating the impact and spread of disease globally. In a region that may not have a robust healthcare system, the capability to collect a sample and transport it to a lab is revolutionary, as often the point of collection and a lab may be a great distance from one another.”
A total of 114 children, ages 0-5, with signs and symptoms of TB provided both a stool and GA sample. Stool was processed via XpertV® MTB/RIF Ultra (Ultra) testing by two methods: the SOS method using 1 g of stool and the PS-MTM method using 150 mg of stool on a swab. Ultra results using the PS-MTM method were highly concordant with results using the SOS method (113/114 results were in agreement), and with the gold standard GA.
To access the IJTLD article, visit https://www.ingentaconnect.com/content/iuatld/ijtld/2023/00000027/00000008/art00006;jsessionid=1tbogpk8bbf67.x-ic-live-02#expand/collapse.
For more information about Longhorn, visit www.LHNVD.com.
About Longhorn Vaccines and Diagnostics LLC
Longhorn Vaccines and Diagnostics LLC is a One Health company based in Maryland that is developing vaccines and diagnostic tools for worldwide public health concerns and to prevent future pandemics. Since its inception in 2006, Longhorn has focused on developing vaccines and diagnostic tools that can impact a pandemic on a global scale and at all socio-economic levels. Since pandemics flow between humans and animals, Longhorn caters to both in order to surveil, diagnose, prevent and treat the next infectious disease.
Longhorn’s core product, PrimeStore® Molecular Transport Medium (MTM), is a patented, FDA cleared, 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 virus 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.
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