A New Dawn in Diagnostic Tools
Philadelphia, PA – In an era where quick, accurate detection can mean the difference between life and death, Instanosis Inc, a trailblazing diagnostic company, has ushered in a new tool to combat the rising opioid crisis in the United States. Their newly-developed InstaStrip-Fentanyl Rapid Test, which has been bestowed with the prestigious Breakthrough Device designation by the FDA, stands at the forefront of rapid fentanyl detection.
The Fentanyl Epidemic: A Snapshot
To truly grasp the significance of this breakthrough, it’s imperative to understand the magnitude of the fentanyl crisis in America. Fentanyl, a synthetic opioid that’s up to 100 times more potent than morphine, has wreaked havoc across the nation. Its potent nature, often mixed unknowingly with other drugs, has resulted in a surge of overdose deaths, becoming the leading cause of such fatalities in the U.S. Communities, families, and individuals from all walks of life have been affected, making it an urgent public health concern.
Why Rapid Detection Matters
Traditional detection methods for fentanyl can be time-consuming and may require specialized equipment. However, with the opioid crisis intensifying, the need for rapid, on-site detection has never been more pressing. InstaStrip-Fentanyl’s design fills this void. Not only does it provide qualitative detection of fentanyl in human urine, but its cutoff value of 1.0 ng/mL ensures it can be utilized both for prescriptions and OTC uses, broadening its accessibility.
Empowering the Public and Healthcare Professionals
The brilliance of InstaStrip-Fentanyl lies not just in its accuracy but in its user-friendliness. This tool empowers a broad spectrum of users, from medical professionals to concerned family members. In a situation where every second counts, such as a potential overdose, having the ability to quickly detect the presence of fentanyl can be a game-changer. The tool’s anticipated widespread OTC availability also positions it as a critical resource in overdose surveillance and early outbreak recognition.
Navigating the FDA’s Breakthrough Device Program
The FDA’s Breakthrough Device program is no easy feat for any medical device to qualify for. It demands that devices not only present innovative solutions but also demonstrate the potential to offer more effective treatment or diagnosis for life-threatening conditions. Instanosis’s achievement in securing this designation underscores the potential impact and significance of the InstaStrip-Fentanyl Rapid Test.
A Response to the Most Pressing Diagnostic Needs
As stated by Dr. Xiaofeng Xia, the Chief Operating Officer of Instanosis, this designation emphasizes the company’s dedication to meeting urgent diagnostic needs head-on. The collaboration with the FDA and the swift advancement of this diagnostic tool highlight Instanosis’s commitment to public health.
What Research Tell Us:
Research continues to be a critical component in understanding the vast and intricate opioid crisis in the U.S. A recent perspective article titled “Testing for Fentanyl — Urgent Need for Practice-Relevant and Public Health Research,” led by authors from National Institute of Health (NIH) and FDA,, and published in the New England Journal of Medicine, underscores the importance of research and development on fentanyl rapid testing in both clinical and harm reduction settings to prevent overdose deaths. A research article titled “Development and Clinical Validation of a Sensitive Lateral Flow Assay for Rapid Urine Fentanyl Screening in the Emergency Department” published by the research lab of Dr. Ping Wang, Founder of Instanosis and Professor at the University of Pennsylvania, detailed the high clinical sensitivity and specificity of the technology used in InstaStrip-Fentanyl.
Looking Forward: The Road Ahead for Instanosis
With the Breakthrough Device designation in hand, the future looks promising for Instanosis and its cutting-edge diagnostic tool. As the company works closely with the FDA, its primary goal remains clear: to ensure this transformative diagnostic tool is available to those who need it most, as quickly as possible. As the nation grapples with the fentanyl crisis, Instanosis’s contribution might just be the game-changer many have been waiting for.
For more comprehensive details about the InstaStrip-Fentanyl Rapid Test and its profound potential impact, visit Instanosis’s official website.