August 1, 2023

Sapient’s High Complexity CLIA Laboratory Receives Accreditation from the College of American Pathologists (CAP)

Submitted by Sapient

San Diego, August 1, 2023—Sapient, a biomarker discovery organization providing bespoke services for metabolomics and lipidomics data generation and analysis, announced that its high complexity CLIA laboratory has been awarded accreditation from the College of American Pathologists (CAP). To achieve accreditation, Sapient passed a rigorous evaluation process that involved an in-depth inspection of its clinical laboratory facilities, equipment, processes, quality control measures, and personnel qualifications.

“As a CLIA-certified lab performing advanced biomarker assays that are deemed ‘high complexity’, we must adhere to the most stringent CLIA regulations. Accreditation by CAP confirms that we uphold or exceed these high standards with exceptional testing proficiency, accuracy, and reliability,” said Nilesh Dharajiya, M.D., CLIA Lab Director at Sapient. “I’m incredibly proud of our team to be recognized by CAP for their diligence and commitment to excellence in every aspect of our clinical lab operations.”

“The results from the biomarker tests we develop and perform under CLIA can be used to direct patient care, be it for diagnosing disease, to identify responders vs. non-responders to a specific drug, or to evaluate drug safety and dosing strategies during clinical trials,” said Mo Jain, M.D., PhD, Founder and CEO of Sapient. “Our clients rely on this data to guide their decision-making and ensure patient safety. It was very important for us to pursue CAP accreditation, to give customers the utmost confidence in our ability to develop robust clinical tests and provide accurate results that adhere to strict regulatory requirements.”

“As an organization, we are committed to upholding a culture of quality and to thoughtfully evolving our service offerings to meet the needs of our clients,” Dr. Jain continued. “With our CLIA-certified, CAP-accredited laboratory, we are able to support rapid translation of the biomarker discoveries we make for our biopharma customers to regulated clinical applications, and to further accelerate development and deployment of much-needed diagnostics and therapies.”

About Sapient: Sapient is a biomarker discovery organization providing bespoke services for metabolomics and lipidomics data generation and analysis, using state-of-the-art, high-throughput mass spectrometry technologies that enable rapid, non-targeted measure of thousands of small molecule biomarkers in human, preclinical, and cellular biosamples. These technologies are leveraged within a larger discovery infrastructure that includes a comprehensive biocomputational framework for analysis of large-scale spectral data, robust quality control analysis, and mapping of key biomarker-phenotype associations. Sapient can cross-validate discoveries using its proprietary in-house longitudinal Human Biology Database that includes mass spectrometry measures from over 100,000 human biosamples linked with corresponding clinical and multi-dimensional -omics data. Together these approaches enable rapid identification, validation, and translation of small molecule biomarkers of biological processes, disease mechanisms, and drug responsiveness across all drug development phases.

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Media Contact: Carla Nieser, Head of Marketing, Sapient [email protected], 858.290.7010.