Senzo, a global life sciences company developing high-accuracy, low-cost, point-of-care diagnostic technologies, today announced a partnership with BARDA, part of the Administration for Strategic Preparedness and Response (ASPR), in the US Department of Health and Human Services (HHS) to assist in bringing Senzo’s Amplified Lateral Flow (ALF) COVID-19 test in achieving U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) to market.
PHILADELPHIA – October 27, 2022 – (Newswire.com)
This contract follows Senzo’s recent announcements about the receipt of ISO 13485:2016 certification, and completing a $2 million Pre-Series A financing led by BioAdvance, to apply the ALF technology to other targets such as Flu A/B, Tuberculosis, HIV, C. diff, Sexual Health, and Hepatitis C.
Senzo’s core innovation is its Amplified Lateral Flow (ALF) technology which significantly increases the sensitivity of traditional-format lateral flow tests while maintaining specificity. The end result is a fast, low-cost, easy-to-use lateral flow test with the same accuracy as a PCR test, the industry’s gold standard test. The ability to incorporate amplification into a lateral flow test has long been a goal for diagnostics test makers but one which has proven difficult to achieve due to the tendency for amplified tests to return false positives. Senzo recently announced results from a blinded, third-party R&D study demonstrating that its Amplified Lateral Flow (ALF) COVID-19 antigen test was 100% accurate in concordance with PCR testing, even in cases with very low viral levels, which could allow for substantially better and earlier detection of virus compared to current lateral flow tests.
“The faster we can accurately diagnose, the sooner we can take action, begin treatment, and the better the patient outcome. Creating a low-cost, user-friendly diagnostic test which delivers PCR accuracy at the point of care, without the need to send a sample to a laboratory, will improve healthcare— it’s that simple. BARDA’s support of our ALF technology will be instrumental in helping us advance our ultimate goal of bringing ALF tests to market,” said Jeremy Stackawitz, CEO of Senzo.
This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50122C00041.
About Senzo:
Senzo is an in vitro diagnostics company developing innovative, accurate, and accessible testing products. Senzo was founded with the vision of utilizing novel technologies focussed on enhanced sensitivity, to create mobile, point-of-care, self-testing products and devices with the ability to accurately, quickly, and cost-effectively conduct testing where healthcare professionals and patients need it most. Senzo is creating game-changing products to bring testing to the patient, eliminating the need for the current slow, expensive central-lab testing paradigms. With insights generated at the point of care, patients can make better decisions faster, and healthcare professionals can identify life-threatening diseases at an earlier stage, improving treatment outcomes and saving lives. www.senzo.com.
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Original Source:
Senzo Receives Funding From the Biomedical Advanced Research and Development Authority (BARDA) to Advance Its PCR-Accurate Lateral Flow COVID-19 Test
