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Subject: FDA

First Light Diagnostics Receives FDA Clearance for its Rapid Clostridiodes difficile Test on the MultiPath® Analyzer

CHELMSFORD, Mass., July 20, 2021 /PRNewswire/ -- First Light Diagnostics is developing and commercializing breakthrough automated diagnostic products for rapidly detecting infections and determining optimal treatment. The company announced today that the US Food and Drug Administration (FDA) has cleared its SensiToxtm C. difficile Toxin Test along with its proprietary MultiPath Analyzer to be marketed in the US.

C.difficile causes more life-threatening hospital infections than any other pathogen and is considered by the CDC to be an urgent antibiotic resistance threat. Each year, approximately 250,000 C. difficile infections and 12,500 deaths cost the US healthcare system about $1B. Currently, both nucleic acid amplification tests and enzyme immunoassays are used to diagnose C. difficile infections. Nucleic acid amplification tests are very sensitive but lack specificity. Enzyme immunoassays, designed to detect toxins produced by C. difficile, are specific but cannot detect low levels of toxin. Because of these limitations, neither test method alone is accurate for the diagnosis of C. difficile infection. First Light aims to improve diagnosis of C. difficile by commercializing an accurate test that is both sensitive and specific.

The SensiTox C. difficile Toxin Test uses the Company's proprietary MultiPath technology for single molecule counting to ultrasensitively detect toxins and biomarkers at much lower levels than most rapid tests on the market. The SensiTox C. difficile Toxin Test aligns with the current clinical guidance for the diagnosis of C. difficile infection that recommends use of toxin tests that very sensitively detect toxin levels. First Light's test, which detects C. difficile toxins A and B was evaluated in a clinical study conducted at three sites in the US that included more than 1,000 specimens. In this study, the test was shown to have excellent clinical sensitivity and specificity. The test delivers a result in 35 minutes on the MultiPath Analyzer, a fully automated benchtop system with high throughput and continuous random access loading of specimens.

"We are very pleased with the results of the clinical study and are convinced our test has enormous clinical value in the diagnosis and rapid treatment of C. difficile infection," said Joanne Spadoro, President and Chief Executive Officer of First Light Diagnostics. "This is an important first step toward our goal of improving patient outcomes by empowering clinicians with more accurate and rapid test results."

In addition to its SensiTox C. difficile Toxin Test, First Light is developing a portfolio of products for the rapid generation of antimicrobial susceptibility test (AST) results, enabling clinicians to prescribe the optimal targeted, narrow-spectrum therapy in hours instead of the days it currently takes. The first test under development is the UTI-Directtm test that rapidly detects urinary tract infections, identifies pathogens, and determines optimal antibiotic treatment.

About First Light Diagnostics, Inc.

First Light Diagnostics is developing and commercializing a broad range of breakthrough diagnostic products to rapidly and sensitively detect life-threatening infections, determine effective antibiotics early in the course of infection, and attenuate the spread of antibiotic resistance. Based on its proprietary single cell and single molecule 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. This will improve patient outcomes, reduce healthcare costs, and prevent inappropriate use of powerful antibiotics. Don Straus is the company's Founder and primary inventor of the company's core scientific technology. To learn more, please visit: www.firstlightdx.com

Company Contact:

Joanne Spadoro, Ph.D.
President and CEO
First Light Diagnostics, Inc

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First Light Diagnostics is developing and commercializing a broad range of breakthrough diagnostic products to rapidly and sensitively detect life-threatening infections, determine effective antibiotics early in the course of infection, and attenuate

SOURCE First Light Diagnostics

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