SAN DIEGO, CA – Mindera Corporation has announced that its San Diego diagnostics laboratory has successfully passed the State of California survey for Clinical Laboratory Improvement Amendments (CLIA) certification. Under this certification, Mindera now has permission to begin offering molecular diagnostic services to patients.
Mindera has a developed a novel platform to extract thousands of biomarkers (RNA, DNA, proteins) from an individual patient via a dermal biomarker patch. Captured RNA is then sent to a CLIA lab for molecular analysis. Using Machine Learning, these biomarkers are correlated to clinical outcomes data from myriad psoriasis patients who receive specific biologic drugs, resulting in predictive analyses for personalized drug responses. Systemwide, predicting biologic responses through Mind.Px can result in both improved patient outcomes and billions of dollars of annual cost avoidance to the healthcare system.
“Achieving CLIA certification of our laboratory is a milestone achievement for our company and an important step towards the realization of our vision of bringing personalized medicine to dermatology,” said Tobin Dickerson, Ph.D., CSO and Co-founder of Mindera. “With this approval, we have begun our next growth phase which will culminate in bringing Mind.Px to the market. I commend our team on the accomplishment.”
The CLIA regulations include federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease. CMS regulates this testing in the United States through the CLIA. The Centers for Disease Control and Prevention (CDC), in partnership with CMS and FDA, supports the CLIA program and clinical laboratory quality.
Mindera is a private San Diego-area company developing and commercializing next-generation medical technology to enable a new era of skin analytics at the molecular level. Using a proprietary dermal biomarker patch, Next-Generation Sequencing (NGS) and Machine Learning, Mindera technology generates clinically validated data to reduce healthcare system costs and improve patient outcomes. Find out more at www.minderadx.com.