First Gentle Diagnostics Receives FDA Clearance for its Fast Clostridiodes difficile Take a look at on the MultiPath® Analyzer

First Gentle Diagnostics is growing and commercializing breakthrough automated diagnostic merchandise for quickly detecting infections and figuring out optimum therapy. The corporate introduced right this moment that the US Meals and Drug Administration (FDA) has cleared its SensiTox™ C. difficile Toxin Take a look at together with its proprietary MultiPath Analyzer to be marketed within the US.

C.difficile causes extra life-threatening hospital infections than every other pathogen and is taken into account by the CDC to be an pressing antibiotic resistance menace. Annually, roughly 250,000 C. difficile infections and 12,500 deaths value the US healthcare system about $1B. Presently, each nucleic acid amplification checks and enzyme immunoassays are used to diagnose C. difficile infections. Nucleic acid amplification checks are very delicate however lack specificity. Enzyme immunoassays, designed to detect toxins produced by C. difficile, are particular however can not detect low ranges of toxin. Due to these limitations, neither check methodology alone is correct for the prognosis of C. difficile an infection. First Gentle goals to enhance prognosis of C. difficile by commercializing an correct check that’s each delicate and particular.

The SensiTox C. difficile Toxin Take a look at makes use of the Firm’s proprietary MultiPath expertise for single molecule counting to ultrasensitively detect toxins and biomarkers at a lot decrease ranges than most fast checks available on the market. The SensiTox C. difficile Toxin Take a look at aligns with the present scientific steerage for the prognosis of C. difficile an infection that recommends use of toxin checks that very sensitively detect toxin ranges. First Gentle’s check, which detects C. difficile toxins A and B was evaluated in a scientific research performed at three websites within the US that included greater than 1,000 specimens. On this research, the check was proven to have wonderful scientific sensitivity and specificity. The check delivers a lead to 35 minutes on the MultiPath Analyzer, a totally automated benchtop system with excessive throughput and steady random entry loading of specimens.

“We’re more than happy with the outcomes of the scientific research and are satisfied our check has monumental scientific worth within the prognosis and fast therapy of C. difficile an infection,” mentioned Joanne Spadoro, President and Chief Govt Officer of First Gentle Diagnostics. “This is a crucial first step towards our aim of bettering affected person outcomes by empowering clinicians with extra correct and fast check outcomes.”

Along with its SensiTox C. difficile Toxin Take a look at, First Gentle is growing a portfolio of merchandise for the fast era of antimicrobial susceptibility check (AST) outcomes, enabling clinicians to prescribe the optimum focused, narrow-spectrum remedy in hours as a substitute of the times it at the moment takes. The primary check below growth is the UTI-Direct™ check that quickly detects urinary tract infections, identifies pathogens, and determines optimum antibiotic therapy.

About First Gentle Diagnostics, Inc.

First Gentle Diagnostics is growing and commercializing a broad vary of breakthrough diagnostic merchandise to quickly and sensitively detect life-threatening infections, decide efficient antibiotics early in the midst of an infection, and attenuate the unfold of antibiotic resistance. Based mostly on its proprietary single cell and single molecule detection expertise, First Gentle’s merchandise mix the scientific efficiency of essentially the most superior industrial laboratory checks with velocity, cost-effectiveness, and ease-of-use. This may enhance affected person outcomes, cut back healthcare prices, and forestall inappropriate use of highly effective antibiotics. Don Straus is the corporate’s Founder and first inventor of the corporate’s core scientific expertise. To be taught extra, please go to:

Firm Contact:

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

Supply: First Gentle Diagnostics