Astek Diagnostics Completes Successful Pre-Submission Meeting with FDA for Jiddu™ Platform
Baltimore, MD – October 29, 2024
Astek Diagnostics Inc. (“Astek”), a leader in precision diagnostics, announced the successful completion of its pre-submission meeting with the U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) for the Jiddu™ Platform, a breakthrough technology for diagnosing urinary tract infections (UTIs) and determining antibiotic sensitivity.
The FDA described the Jiddu™ Platform as a “paradigm shift” in UTI diagnostics, recognizing it as a novel solution to a significant unmet need. Based on the FDA’s recommendations, Astek will focus its initial clinical trials on patients with catheter-associated urinary tract infections (CAUTIs), a vulnerable population with limited diagnostic options. These trials, scheduled to begin in Q2 2025, will be sponsored by MedStar Health and will be conducted across three of its hospital sites.
Astek plans to pursue the De Novo regulatory pathway to accelerate clearance and deliver meaningful healthcare improvements in UTI diagnostics and antibiotic sensitivity testing.
"We are thrilled with the positive feedback from the FDA," said Mustafa Al-Adhami, CEO of Astek Diagnostics. "By focusing on CAUTIs, we aim to address a critical healthcare gap and bring this innovative solution to patients in need."
Dr. Suzanne Groah, a participant in the FDA discussions, noted, “The Jiddu™ Platform addresses an essential diagnostic gap, promising to expedite care and reduce patient suffering. The FDA’s guidance has been invaluable as we advance both care and science.”
The meeting was also attended by Dr. Martin Richman, who commented, “The Jiddu™ Platform revolutionizes the rapid detection of acute urinary tract infections, providing critical antibiotic resistance data to enable faster, more accurate diagnoses and treatments. This timely intervention helps alleviate symptoms sooner and minimizes the risk of complications associated with untreated or mismanaged infections." Astek is already preparing for its clinical trials through three ongoing pilot studies:
A Neurogenic Lower Urinary Tract Dysfunction (NLUTD) study at MedStar Health.
A general urology pilot study at Urologic Surgeons of Washington (pending IRB approval).
A pediatric urology study at Children’s National Hospital (pending IRB approval).
Additionally, Astek launched an Early Access Program, securing letters of intent (LOIs) from key strategic partners such as MedStar Health, University of Maryland School of Medicine, Golden Gate Urology, HALO Dx, Urologic Surgeons of Washington, Albany Medical College, Aceso Health, Lower Keys Urology, PrineHealth, and others. These partnerships include early deployment of the Jiddu™ Platform, data collection, and joint publications, laying the foundation for rapid adoption. With promising interest, the Early Access Program forecasts $30 million in revenues within the first year of FDA clearance.
