Describing rapid and accurate immunoassay-based technology capable of counting single molecules using digital imaging without magnification
Bedford, Massachusetts, October 25, 2018 (Newswire.com) – Bedford, Massachusetts, October 25, 2018 (Newswire) – First Light Diagnostics (formerly First Light Biosciences), a developer of breakthrough automated diagnostic products for rapid, sensitive, and cost-effective diagnostic tests for life-threatening infections today announced the publication of an article entitled, “A Rapid, Accurate, Single Molecule Counting Method Detects Clostridium difficile Toxin B in Stool Samples” in Nature Scientific Reports, a peer-reviewed, open access, multidisciplinary journal.
The paper presents results demonstrating the performance of First Light’s rapid test for Clostridium difficile infection (CDI) using the company’s novel MultiPath digital imaging technology. C. difficile, the bacterial pathogen that causes this devastating gastrointestinal infection, is responsible for about half of all hospital infections and about 29,000 deaths a year in the US. For these reasons C. difficile tops CDC’s list of most urgent threats.
First Light’s MultiPath CDI test uses ultra-sensitive single-molecule counting to detect the toxins that cause CDI. The newly published results demonstrate the test’s potential to detect the disease-causing toxins at levels about 20-50 times lower than current toxin tests. On a set of 320 clinical stool samples, the MultiPath C. difficile toxin B test showed 97.0% clinical sensitivity (95% CI, 91.4–99.4%); 98.3% specificity (95% CI, 96.8–99.2%); and 98.2% accuracy (95% CI, 96.7–99.0%) compared to the FDA gold standard test.
“We are pleased with the results of our C. difficile study,” said David Macdonald, CEO of First Light Diagnostics. “Currently, there are no tests for this toxin that are rapid, sensitive and specific. Our peer-reviewed research offers compelling evidence that the MultiPath can address this issue.”
About First Light Diagnostics
First Light Diagnostics is developing and preparing to commercialize, innovative diagnostic products for rapid, sensitive and cost-saving detection of life-threatening infections, and combating the spread of antibiotic resistance. Don Straus is the company’s Founder and primary inventor of the company’s core scientific technology. Based on its proprietary MultiPath™ detection technology, First Light’s products combine the clinical performance of the most advanced commercial laboratory tests with speed, cost-effectiveness, and ease-of-use. The tests rapidly detect infections, identify infectious agents, and determine effective targeted antibiotic therapy. This will improve patient outcomes, reduce healthcare costs, and prevent inappropriate use of powerful antibiotics. To learn more, please visit: www.firstlightidx.com
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