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Studies Feature Clinical Validations of Clozapine Point of Care Testing Using a Single Drop of Blood to Aid Psychiatrists in Better Treatment of Patients With Schizophrenia

Saladax Biomedical, a commercial-stage diagnostics company, today announced that positive data demonstrating the performance of a point of care testing device for the antipsychotic drug clozapine, was presented at the 2019 European College of Neuropsychopharmacology (ECNP) Annual Meeting and the International College of Neuropsychopharmacology (CINP) Annual Meeting. The device called MyCareTM Insite measures patients' clozapine levels using a single drop of blood from a finger stick. The test takes six minutes so mental healthcare professionals can make immediate decisions in the care of their patients. MyCare Insite is the first and only rapid point of care test available for determining levels of clozapine.

The aim of this study was to confirm the accuracy of the MyCare Insite Clozapine Test compared to the laboratory method that is normally used to determine levels of clozapine. The posters highlight a 399 patient sample, multisite study at the Maryland Psychiatric Research Center, University of Maryland School of Medicine, the Institute of Psychiatry at the Maudsley, and Kings College London. The study results showed agreement between the MyCare Insite and the laboratory test. This study demonstrates that the MyCare Insite Clozapine Test, which provides results at point of care using only a drop of blood, are comparable to laboratory-based tests, which need tubes of blood and can take days to get results. The MyCare Insite could be used to meet an unmet clinical need by providing psychiatrists with clozapine levels in six minutes.

The work was presented by Matt Atkins and Professor David Taylor of the Institute of Psychiatry at the Maudsley and King's College London.

Details are as follows:

Poster: Point of Care Testing for Clozapine
Date: Tuesday, Sept 10, 2019
Time: 13:00 -14:30 CDT
The poster and authors are available to view at this link. The annual meeting took place at the Bella Convention Center in Copenhagen, Denmark.
Click here to view poster.

Poster: Evaluation of a Novel Point of Care Testing Device for Rapid Measurement of Clozapine in Whole Blood
Date: Thursday, Oct 3, 2019
Time: 12:00 - 13:00
The poster and authors are available to view at this link. The annual meeting took place at the at the Royal Olympic Hotel in Athens, Greece.
Click here to view poster.

For more information:


The MyCare Insite Clozapine Test is intended for the in vitro quantitative measurement of clozapine in human capillary finger blood using the MyCare Insite.


Founded in 2004, Saladax Biomedical, Inc. is a privately held company headquartered as an anchor tenant at Ben Franklin TechVentures® located on Lehigh University's campus in Bethlehem, PA.

Saladax develops rapid blood tests for point of care testing and for laboratory analysers for use in psychiatry and oncology. The Saladax MyCare Psychiatry line provides drug levels for greater insight into patient adherence and possible causes of treatment failures. Saladax is changing psychiatry by using just a single drop of blood.

These tests enable psychiatrists to more accurately assess adherence and better adjust medication dosing. Saladax believes that truly personalized medicine can only exist when the right drug is taken at the right dose. Our diagnostic reagent kits are distributed worldwide, and FDA approval is pending in the United States.

For more information, visit Saladax.com or MyCareTests.com.

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News published on 24 october 2019 at 10:05 and distributed by: