Hair analysisPsychemedics receives additional FDA clearances for hair analysis drug testing

Acton, Massachusetts-based Psychemedics Corporation, a hair testing specialist, announced that the Food and Drug Administration (FDA) granted the company 510(k) clearances for five new, additional assays to test for the detection of cocaine, opiates, PCP, methamphetamine, and marijuana using enzyme immunoassay (EIA) analysis of head and body hair.

Psychemedics developed a technology, using FDA-cleared radioimmunoassays (RIA), for the detection of drugs of abuse, and says it was the first laboratory to receive FDA clearances ten years ago for screening assays used in hair testing for drugs of abuse. 

The newly developed immunoassays produced by the R&D team at Psychemedics were designed specifically to meet the standards of radioimmunoassay, and represent atechnological breakthrough.  Psychemedics says that because it is the only hair testing laboratory that manufactures its own screening assays, it has full control over all aspects of its technology. In addition, Psychemedics says it remains the only laboratory to have FDA clearances for all five drug classes for both head and body hair.

On 24 January 2012, Psychemedics announced that the U.S. Patent and Trademark Office issued the company its seventh patent, which covers a soft digestion process that releases drugs trapped in the hair without destroying the drugs.  The new patented method can be used with a broad range of immunoassay screen techniques, mass spectrometry methods and chromatographic procedures.

Raymond C. Kubacki, chairman and CEO of the company, said: “We are pleased to have received this patent, which is fundamental to all hair analysis drug testing and enhances our ability to identify more drug users.  Continued investment in the development of the science is critical to Psychemedics and we remain the only company to obtain patents for getting the drugs out of the hair — a very critical first step in the detection process.  This new patent covers the breakdown of the hair structure to release the drugs without destroying them — removing virtually 100 percent of the drugs from the hair.  This patent is fundamental to hair analysis drug testing because if you cannot get all the drugs out of the hair, you cannot accurately measure them; and if you cannot accurately measure the drugs, you cannot identify all the drug users.  This is now our second fundamental patent focused on removing drugs from the hair, following our initial patent issued in 1994.”

Kubacki continued, “Our company has, for twenty-five years, offered the most effective hair testing technology based upon scientifically validated drug testing methods.  By combining our new FDA-cleared immunoassays, which are equivalent in effectiveness and sensitivity to radioimmunoassay, with our new patented method of releasing the drugs from the hair, we continue to offer truly proprietary technology that provides superior detection of drugs of abuse.  This is what sets us apart.”