#United States #San Diego #LuminoDx #CLIA Certification

LuminoDx Receives CLIA Certification

LuminoDx, a pioneering diagnostic company based in San Diego, is excited to announce its laboratory has attained the Clinical Laboratory Improvement Amendments (CLIA) certification. This significant accomplishment, granted by the Centers for Medicare and Medicaid Services (CMS), permits the lab to accept and perform diagnostic tests on human samples, marking a crucial step in advancing healthcare solutions.

According to Yipeng Wang, co-founder and CEO of LuminoDx, "This certification allows us to begin testing patient samples with our first liver health-related test, the Factor V assay." This test is pivotal as it initiates the company's foray into clinical validations and promises patients accurate diagnostics, particularly for liver health issues.

In the immediate future, LuminoDx plans to expand its testing menu to include a test that predicts liver rejection following transplant surgeries, further cementing its commitment to enhancing patient care. Having the capability to clinically validate Laboratory Developed Tests (LDTs) not only extends LuminoDx's offerings but also supports biotechnology and pharmaceutical firms in their quest to develop targeted therapeutic solutions.

The scientific leadership at LuminoDx, comprising co-founders Gordon Vansant and Yipeng Wang, boasts a wealth of technical knowledge spanning various scientific platforms. They have backgrounds in developing assays and conducting tests from both clinical and non-clinical studies that aid therapeutic drug development, including fields like nucleic acids analysis, proteomics, and metabolomics.

Gordon Vansant, who serves as the Chief Business Officer, expressed, "With the CLIA validation of our GLP-compliant laboratory, we can now analyze patient samples across multiple platforms. This will yield critical results that enhance patient decision-making." This broad spectrum of analytical capabilities positions LuminoDx as a leader in the diagnostics space, particularly in liquid biopsy and molecular testing, thus facilitating improved patient outcomes.

LuminoDx is dedicated to developing innovative diagnostic solutions. With over 80 years of combined expertise in the field, the company focuses on its flagship liquid biopsy solution designed specifically for post-liver transplant management. This service utilizes proprietary biomarkers to enable precision monitoring of allograft health, optimization of immunosuppressive therapies, and reduction in the risk of comorbidities, which are essential for kidney transplant patients and others requiring liver care.

In addition to its pioneering liver health solutions, LuminoDx offers services in Olink proteomics analysis, analysis of extracellular vesicles (EVs), and microRNA detection, broadening its impact within both clinical and research applications.

The decision to seek CLIA certification demonstrates LuminoDx's commitment to high standards of diagnostics. The achievement of this certification not only reflects the quality of their services but is a vital step toward empowering healthcare providers and patients with reliable diagnostic tools that are crucial for effective medical decisions.

To learn more about LuminoDx and its innovative offerings, visit their official website at www.luminodx.com.