Saladax Biomedical, Inc. (Saladax) is pleased to announce the signing of a global distribution agreement with Beckman Coulter, Inc. to distribute the MyCare™ Psychiatry Laboratory Assays. The MyCare™ Psychiatry Laboratory Assays measure drug levels of the antipsychotic drugs prescribed to treat patients with serious mental illness (SMI), such as such as Schizophrenia and Bipolar Disorder.

Saladax’s assays address a significant unmet clinical need for patients with SMI by providing healthcare professionals (HCPs) a rapid, low-cost, and accurate antipsychotic drug blood level. These assays run on automated clinical analyzers in laboratories, significantly shortening the time to results as compared to traditional testing.

“Together with Beckman Coulter, Inc., a leading global manufacturer of automated clinical analyzers, we will greatly increase access to this testing to improve the care of patients with serious mental illness,” stated Sal Salamone, CEO and Founder, Saladax.

SMI is a significant public health concern. The estimated economic impact of SMI in the United States (U.S.) is more than $300 billion each year with the number of people that SMI affects growing rapidly. Current data shows that more than 13 million adults in the U.S. experienced SMI in the past year. That is more than 5% of the adult population.¹ Schizophrenia and Bipolar Disease alone account for more than $88 billion dollars in direct healthcare costs.²

Recognizing the need to provide HCPs quantitative insights to manage patient therapy, clinical guidelines recommend the routine measuring and monitoring of drug levels. Saladax is positioned as the leading diagnostic company in the field of antipsychotic drug monitoring with 345 validated patents worldwide that cover 80% of the commercial tests run for antipsychotic drug therapeutic monitoring.³

“I am very excited to launch this partnership with Beckman Coulter. The Beckman Coulter sales and support channels will increase the availability of these much-needed tests,” stated Sal Salamone. “This is a major step in allowing HCPs to make reliable assessments by providing timely quantitative insights.”

“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 maintained. 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,”⁴ said Kathleen Orland, senior vice president & general manager, clinical chemistry and immunoassay.

To learn more about our Antipsychotic Drug Monitoring and Therapeutic Drug Monitoring menu, visit BeckmanCoulter.com/Antipsychotic.

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

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.

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.

1. Substance Abuse and Mental Health Services Administration. (2020). Key substance use and mental health indicators in the United States: Results from the 2019 National Survey on Drug Use and Health (HHS Publication No. PEP20-07-01-001, NSDUH Series H-55). Rockville, MD: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration.
2. Bessonova L, Ogden K, The Economic Burden of Bipolar Disorder in the United States: A Systematic Literature review 2011. doi: 10.2147/CEOR.S259338
3. Magellan 2016 Rx Management Medicaid Trend Report.
4. 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

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