Saladax Biomedical Inc., a diagnostics company providing kits to test drug levels for adherence and personalized dose management, announced today that it has received CE mark (Conformité Européenne) approval for its first two products in the new MyCare™ Psychiatry line of rapid tests for antipsychotics: MyCare Total Risperidone Assay Kit and MyCare Paliperidone Assay Kit. The products are now approved for sale on the European market.

The new tests measure total risperidone or paliperidone in patients’ blood. The immunoassays are run in clinical chemistry laboratories on routine high-throughput instruments. Rapid test results could help guide physicians in their decision-making process by providing objective evidence of medication levels within clinically relevant time. Tests for antipsychotic blood levels could be used to assess adherence, or to ascertain causes for lack of response or toxicity. Where guidelines exist, blood levels could also help assess the likelihood of clinical effect in patients treated with antipsychotics.

DeWayne Davenport, Sr. VP of Strategic Initiatives, stated, "Despite the availability of efficacious drugs, managing patients’ treatment with antipsychotics is a significant challenge in psychiatric medicine. With notoriously high rates of poor antipsychotic drug adherence and limited means to detect it, prescribers are often uncertain whether a lack of treatment response is due to poor adherence, or true lack of effect, which in turn may simply reflect insufficient drug concentration."

Mr. Davenport went on to say, "Saladax MyCare Psychiatry line of tests offers a major advance in the field of Personalized Medicine. The results of the test can be available to the doctor as early as one hour from blood draw in certain settings, and within 48 hours in many others. This gives MyCare products an advantage over current methods which can take up to a week or longer. Doctors now have a new tool to provide greater clarity on the causes of treatment failure that may help distinguish medication non-response from lack of adherence."

More than 18 million patients are on antipsychotics worldwide. The failure rate for these medications can be as high as 50%. While there are many factors contributing to this inadequate treatment response, many journals and psychiatrists point to rapid drug level tests as an important tool to reduce treatment failure.

Dr. Salvatore Salamone, President & CEO, commented, "drug levels should be widely used to assess adherence and toxicity, and also to assess likelihood of clinical effect in patients treated with the antipsychotics for which adequate evidence exists. People have used less effective ways of dealing with adherence, such as pill counts and questionnaires, which we know are quite unreliable. The MyCare tests will tell you precisely if there is drug in the body, and if there are still issues that you need to consider. Until now, psychiatrists had to send samples out to a specialty lab, and results could take a week or longer. Now, both hospitals and centralized laboratories will be able to provide results in a shorter amount of time."

The Saladax MyCare Psychiatry line will include tests for total risperidone, paliperidone, clozapine, olanzapine, quetiapine, and total aripiprazole. All six tests will have CE mark approval this year.

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