PHILADELPHIA, PA — Instanosis Inc. announced that the U.S. Food and Drug Administration has granted Breakthrough Device Designation to its Xylazine Rapid Test (Urine), a diagnostic device designed to detect the presence of xylazine in urine samples.
The company said the designation is intended to expedite the development and regulatory review of devices that may provide more effective diagnosis or treatment of life-threatening or irreversibly debilitating conditions.
Xylazine is a veterinary sedative not approved for human use that has increasingly been detected in the illicit drug supply, often in combination with fentanyl and other synthetic opioids. Health officials have reported that naloxone does not reverse the effects of xylazine, which has been associated with respiratory depression, prolonged sedation and soft tissue injury.
Instanosis said its rapid test is intended to support healthcare providers, laboratories and public health professionals in identifying potential xylazine exposure and monitoring evolving drug trends.
Under the FDA’s Breakthrough Device program, the company will receive prioritized interaction and review as it advances the device through its regulatory pathway, according to Instanosis.
“The FDA’s Breakthrough Device Designation is a significant milestone for our development program,” said Dr. Xiaofeng Xia, chief operating officer of Instanosis. “This designation enables enhanced interaction with the Agency as we execute our clinical and regulatory strategy.”
Instanosis is a Pennsylvania-based diagnostics company focused on developing rapid testing technologies for clinical and community settings.
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