Saladax Biomedical Inc. of Bethlehem, a diagnostics company providing kits to test for drug-level adherence and dose management, said it has received approval to sell two of its products on the European market, an approval the company called a major opportunity.
The company received the CE mark, or Conformite Europeenne, which allows it to sell the first two products in its MyCare Psychiatry line of rapid tests for antipsychotics – used primarily to treat schizophrenia.
There are six tests.
The company is working to get the first of the tests approved by the Food & Drug Administration, but those approvals take more time, according to Saladax spokesman Salvatore Salamone.
The total worldwide market for these tests is about $2 billion, he said.
According to a release, the new tests measure the total antipsychotic medication in a patient’s blood.
DeWayne Davenport, senior vice president of strategic initiatives for Saladax, said the tests assist with a big problem with patients failing to take the right dose of medicine.
“Despite the availability of efficacious drugs, managing patients’ treatment with antipsychotics is a significant challenge in psychiatric medicine,” he said. “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.”
More than 18 million patients are on antipsychotics worldwide, according to Saladax. The failure rate for these medications can be as high as 50 percent.
“Doctors now have a new tool to provide greater clarity on the causes of treatment failure that may help distinguish medication nonresponse from lack of adherence," he said.
Salamone noted that there are tests on the market to test for antipsychotics in the blood, but those are slower, and speed is very important when dealing with drug adherence.
He said there is a significant demand for better testing.
He said the annual cost of schizophrenia in the United States is estimated at $24.9 billion in direct medical costs and $62.1 billion in indirect costs.
Founded in 2004, Saladax Biomedical Inc. is a privately held company headquartered as an anchor tenant with Ben Franklin TechVentures in Bethlehem.