The FDA formally warned three providers of direct-to-consumer DNA tests about medical claims the companies make that the federal watchdog agency hasn’t approved.
The FDA wants the companies; American International Biotechnology Services, Lumigenix Inc and Precision Quality DNA; to either furnish evidence of device approval or make a case that their products don’t fall under the FDA’s purview.
American International Biotechnology Services (formerly CBI Services) sells a Sports X Factor Test Kit it claims can predict the risk for certain health conditions, including undiagnosed heart conditions. The FDA issued a warning letter to the Richmond, Va.-based company, asking for clearance or approval numbers to demonstrate that the claims were reviewed.
Behavioral Health, Interoperability and eConsent: Meeting the Demands of CMS Final Rule Compliance
In a webinar on April 16 at 1pm ET, Aneesh Chopra will moderate a discussion with executives from DocuSign, Velatura, and behavioral health providers on eConsent, health information exchange and compliance with the CMS Final Rule on interoperability.
The letters follow an independent FDA panel advisory that doctors be involved with the use of personal genetic tests.
Lumigenix Inc recieved a similar warning for advertising that its tests uncover genetic risk factors for 79 diseases. Lumigenix’s marketing touts its ability to uncover heightened risk for everything from lactose intolerance to ovarian cancer. The Palo Alto, Calif.-based company said it plans to cover more than 70 new diseases and traits by the end of the year.
Precision Quality DNA of Fallon, Nev., calls itself a “DNA Guidance service,” warning consumers to “dodge the bullet with your name on it.” The FDA expressed concerns about Precision Quality’s claims to provide insight into individuals’ likely reponse to specific drugs and promises to highlight risk factors based on main target genes.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
