Beckman Coulter Introduces Antipsychotic Drug Testing to Address Unmet Clinical Need for More Than 69 Million People Living with Serious Mental Conditions


Global distribution agreement with Saladax Biomedical brings antipsychotic therapeutic drug monitoring assays to Beckman Coulter customers

BREA, CALIF., March 15, 2022 — Beckman Coulter, a global clinical diagnostics leader, announces it will introduce new antipsychotic drug tests to laboratories and clinicians to address an unmet clinical need for 69 million people with serious mental conditions worldwide.

In a new agreement with Saladax Biomedical, Inc., Beckman Coulter will distribute the tests designed to measure blood levels of antipsychotic drugs prescribed to treat patients with serious mental illness (SMI), such as Schizophrenia and Bipolar Disorder. These new assays are developed using an innovative nanoparticle technology and empower health care professionals with data to monitor psychiatric drugs prescribed in treatment of psychosis: Clozapine, Risperidone/Paliperidone, Olanzapine, Quetiapine, Aripiprazole.

The rapid, high-quality assays run on Beckman Coulter’s scalable AU clinical chemistry analyzers and shorten turnaround time for patient test results to hours instead of days – leading to greater success managing and monitoring treatments for inpatients and outpatients.

Serious mental illness is a significant public health concern. Worldwide 45 million1 people are affected by bipolar disorder and 24 million2 people are living with schizophrenia. Patients with untreated schizophrenia or bipolar may experience increased intensity of symptoms which could be disabling, potentially resulting in additional medical care or could lead to suicide.3,4 These new assays assist healthcare professionals evaluate patient treatment adherence and individual patient drug response.

Kathleen Orland, senior vice president & general manager, clinical chemistry and immunoassay, Beckman Coulter, says: “Beckman Coulter’s portfolio of therapeutic drug monitoring assays offers laboratories and diagnostic testing facilities ways to improve patient care by ensuring therapeutic ranges are monitored. Our relationship with Saladax expands access for laboratories and clinicians to antipsychotic drug testing for treatment of psychotic disorders, which is a growing healthcare need.”5

Sal Salamone, CEO and Founder, Saladax, says: “Our partnership with Beckman Coulter is a major step in making these important antipsychotic tests available to health care professionals. These tests provide timely quantitative insights so they can make reliable assessments that will improve the care of patients with serious mental illness.”

Assays are being introduced across Europe and the United States, with plans to expand to Beckman Coulter customers globally. Please contact your Beckman Coulter sales representative or distributor for information about this product and availability in your region.6

For more information about Beckman Coulter’s Antipsychotic Drug Testing addition to Therapeutic Drug Monitoring, visit www.beckmancoulter.com/antipsychotic. 

About Beckman Coulter, Inc.
Beckman Coulter is committed to advancing healthcare for every person by applying the power of science, technology, and the passion and creativity of our teams to enhance the diagnostic laboratory’s role in improving healthcare outcomes. Our diagnostic systems are used in complex biomedical testing and found in hospitals, reference laboratories, and physician office settings around the globe. Beckman Coulter offers a unique combination of people, processes, and solutions designed to elevate the performance of clinical laboratories and healthcare networks. We do this by accelerating care with a menu that matters, bringing the benefit of automation to all, delivering greater insights through clinical informatics, and unlocking hidden value through performance partnership. A subsidiary of Danaher Corporation since 2011, Beckman Coulter, Inc. is headquartered in Brea, Calif., and has more than 11,000 global associates working diligently to make the world a healthier place.

About Saladax Biomedical, Inc.
Headquartered in Bethlehem, PA, Saladax Biomedical, Inc. is a privately held company that develops, manufactures, and markets assays that provide rapid therapeutic drug levels for essential and life-saving medicines prescribed by psychiatrists and oncologists. Since 2007, Saladax's proprietary technology has been used in clinical laboratories or point-of-care settings to assist clinicians in monitoring and optimizing patient care. Additionally, the company collaborates with leading pharmaceutical companies to develop tests for clinical trials and companion diagnostics. For more information, visit MyCareTests.com.

1. GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. (2018). Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. The Lancet. DOI:https://doi.org/10.1016/S0140-6736(18)32279-7)

2. https://www.who.int/news-room/fact-sheets/detail/schizophrenia

3. https://www.nimh.nih.gov/health/topics/schizophrenia

4. https://www.nimh.nih.gov/health/topics/bipolar-disorder#part_2264

5. Therapeutic Drug Monitoring Market by Product, End-user, Drug Class, and Geography - Forecast and Analysis 2020-2024. https://www.technavio.com/report/therapeutic-drug-monitoring-market-industry-analysis

6. CE Marked. Some tests are not yet available for sale in the U.S. and have not yet been cleared by the U.S. Food and Drug Administration. Global market does not currently include China, Hong Kong or Macao.