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Invisible Sentinel’s First-in-Class, Same-Day Legionella Assay Meets CDC ELITE Requirements

Invisible Sentinel Inc., a Philadelphia-based global molecular solutions company announced today that its first-in-class Legionella species assay has been verified and adopted by Q Laboratories, Inc., a Centers for Disease Control (CDC) ELITE Certified Laboratory.

CDC ELITE, which stands for Environmental Legionella Isolation Techniques Evaluation, is an important CDC designation reserved for laboratories that demonstrate proficiency in isolating, growing, and identifying Legionella from environmental samples using traditional culture-based microbiology methods. Established in 1966, Q Laboratories is based in Cincinnati, Ohio, and provides analytical chemistry, microbiology and research and development laboratory services. Q Laboratories has multiple accreditations including pharmaceutical testing FDA registration, cGMP/GLP, CDC ELITE and ISO/IEC 17025, and is an industry leading laboratory for the testing of food, food ingredients, cosmetics, pharmaceuticals, environmental samples, and water quality.

Legionella causes acute respiratory disease that can lead to hospitalization and death. The bacteria typically reside in water cooling towers, swimming pools, hot tubs and ventilation systems, where it can become aerosolized and infectious to humans. Schools, hospitals, hotels, and long-term care facilities undergo regular monitoring to ensure that they are free of Legionella. However, traditional screening methods can take up to two weeks to deliver results.

Veriflow Legionella is a rapid, molecular assay for the detection of Legionella species from environmental and water samples. The assay provides results in less than 4 hours, improving turn-around-time by more than 7 days compared to the current CDC culture-based method. Veriflow’s innovative DNA Signature Capturing technology is also able to distinguish between viable and non-viable organisms, thus providing same-shift actionable results to end users that can empower near-immediate remediation of contamination.

“We spent several years developing this assay to ensure it would meet the high standards set by ELITE CDC certified testing laboratories and we expect it to be a game-changer for the water testing market,” said Dr. Nicholas Siciliano, Invisible Sentinel’s CEO.

The increasing incidence of Legionella outbreaks, and new regulations calling for increased routine monitoring, have driven the need for faster and more accurate detection tools. “As current demand for rapid and accurate detection of Legionella in water sources increases, the technology offered by Invisible Sentinel’s Legionella assay holds great promise in the water testing market as a new and unique tool allowing detection of only live Legionella cells.,” said Joe Benzinger, Q Laboratories’ Microbiology Research & Development Project Leader.

“We’re excited to partner with Q Laboratories, a market leader in assay validation and microbiology testing services, to formally launch our groundbreaking Legionella assay to the entire industry,” Siciliano added.

Veriflow® Legionella and other assays are available directly from Invisible Sentinel. Invisible Sentinel has also developed a suite of detection tools for pathogen and spoilage organisms in food, wine, beer, and juice.

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