Spot On Sciences Earns Warning Letter Over Marketing Slips

Spot On Sciences marketed its products for diagnostic testing despite telling the FDA they were intended for research use only, according to a recent warning letter.

In April 2014, the Austin, Texas, company told the FDA that its HemaSpot collection devices are for research use only and are not for use in diagnostic procedures. However, in March of that year, its website had featured a press release about partnering with another company to provide DTC diagnostic testing for various conditions, according to the April 12 letter posted online June 28. The release linked to a website where the devices could be ordered directly by consumers using an online payment service.

Further, statements on the website indicated that the dried blood spot collection devices are used in diagnostic testing. For example, the websites said the devices “greatly increase access to medical testing for chronic diseases and reduce health disparities for underserved and resource-limited populations.” It noted that “people who are home-bound or live in remote and rural areas sometimes lack transportation for routine medical screening.”