No More Guess and Check: Introducing Targeted Obesity Treatment
Phenomix Sciences is developing a blood-based test to determine the underlying characteristics (aka "phenotypes") of obesity. Right now, doctors and patients blindly choose obesity treatments, spending thousands of dollars on something that ultimately, doesn't work that well.
We discovered four prominent obesity phenotypes to help patients choose the right treatment the first time.
Early Traction for Targeted Obesity Testing
We've demonstrated the accuracy of the blood test through three trials at Mayo, and before we launch, will need to validate our laboratory's analytical methods to meet CLIA standards. Unlike medical devices or therapeutics, our laboratory test doesn't need FDA approval because it is considered a laboratory developed test and is to be ordered only by licensed health care providers. We plan to obtain our CLIA registration (through the Centers for Medicare & Medicaid Services, CMS) in Q2 2019, which will allow us to start selling the tests in 45 states.
Initial 500-Patient Mayo Clinic Study
We discovered four obesity phenotypes with the two-day, rigorous test, but wondered if there was a way to make a simpler test.
Validated Blood Test Accuracy
From Jan 2017 until Oct 2017, we completed three trials at Mayo Clinic to determine that the blood test predicts phenotype with 90% accuracy.
As of Oct 2018, we have identified a location for our clinical lab site in Minneapolis. The rest of the year, we will retrofit the space to bring it up to clinical standards.
Analytical Validation in Our Lab
To meet regulatory standards, we must properly validate the performance characteristics of the blood test within the Phenomix Laboratory
Obtain CLIA certificate of registration through CMS, the USA regulatory body for laboratory testing.
Gold Standard Accreditation
Obtain full laboratory accreditation through College of American Pathologists and obtain permits for testing in 4 more states: CA, PA, MD, RI. NY following in 2020