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.
Our company designed the Rapid Test for the qualitative 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. 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 fentanyl 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 becomes increasingly evident.
We are committed to finding solutions, which underscores our unwavering commitment to address pressing diagnostic needs. We collaborate closely with the FDA to ensure that this transformative diagnostic tool reaches those in need as soon as possible.
