Instanosis announces FDA Breakthrough Device designation for InstaStrip-Fentanyl Rapid Test

Instanosis Inc, a leading diagnostic company based in Philadelphia, is proud to announce that its innovative InstaStrip-Fentanyl Rapid Test has achieved the Breakthrough Device designation by the United States Food and Drug Administration (FDA). This notable designation recognizes the device’s potential to be a transformative tool in the fight against the opioid crisis.

The InstaStrip-Fentanyl Rapid Test is designed for the qualitative detection of fentanyl in human urine, with a cutoff value of 1.0 ng/mL, making it suitable for both prescription and over-the-counter (OTC) usage. This test is significant as fentanyl is the primary cause of overdose-related deaths in the United States.

“Rapid and accurate identification of fentanyl presence is crucial in preventing overdoses and making timely clinical decisions,” remarked Dr. Xiaofeng Xia, Chief Operating Officer of Instanosis. “InstaStrip-Fentanyl, when made available OTC, will serve as an indispensable tool for a wide range of individuals, from emergency care providers to friends and family members, allowing them to detect fentanyl swiftly and augment the lifesaving impact of OTC naloxone.” stated Dr. Ping Wang, Founder of Instanosis and Professor at the University of Pennsylvania.

With a cutoff of 1.0 ng/mL, InstaStrip-Fentanyl ensures users can detect fentanyl with lab-level sensitivity, offering rapid results that can be visually interpreted without equipment. Moreover, its accessibility and ease of use empower the general public to participate actively in overdose surveillance and early outbreak recognition, crucial steps in enhancing public health safety.

Achieving Breakthrough Device designation is a testament to Instanosis’s dedication to addressing urgent diagnostic needs. The program accelerates the review process and fosters active communication with the FDA, ensuring timely feedback and guidance. For a device to be considered under this program, it must provide a substantially more effective treatment or diagnosis for life-threatening diseases or conditions.

“We are thrilled with this designation, which underscores our unwavering commitment to address pressing diagnostic needs,” said Dr. Xia. “We are keen to collaborate closely with the FDA to ensure that this transformative diagnostic tool reaches those in need as soon as possible.”

The fentanyl crisis in America has reached alarming proportions, representing a dire public health threat that cannot be overstated. Originally developed for medical use as a powerful synthetic opioid, fentanyl has found its way to the streets, leading to a drastic surge in overdose deaths. In fact, fentanyl and its analogs are now responsible for the majority of opioid-related fatalities in the U.S. Its potency, up to 100 times stronger than morphine and about 50 times more powerful than heroin, makes even minute amounts lethal. The crisis is further exacerbated by fentanyl’s clandestine production and distribution, often mixed unknowingly with other drugs, leaving users unaware of its deadly presence. As communities, healthcare providers, and policymakers grapple with the mounting challenges, the urgency for effective solutions, such as rapid diagnostic tools, becomes increasingly evident.