Berg Diagnostics achieves CLIA certificate of accreditation

Berg Diagnostics, a Boston-based molecular diagnostics company has received Massachusetts Clinical Laboratory Licensure and Certificate of Registration from the Centers for Medicare and Medicaid Services under the Clinical Laboratory Improvement Amendment (CLIA). 

"The achievement of a CLIA certificate of accreditation informs clients that the laboratory has established a sound foundation of quality and management to assure the accuracy, reliability, and timeliness of patient results," states Mark Kellogg, PhD, MT (ASCP), DABCC, FACB, Associate Director of Chemistry and Director of Laboratory Quality at Children's Hospital Boston, Harvard Medical School.

The CLIA licensure positions the company to enable program designs both for discovery based and clinical diagnostics services acting as fee-for-service, R&D collaborations, and license/royalty agreements where intellectual property could be commercialized under partnership agreements.

"This allows the company to immediately diversify its business operations to clinical biomarker validation, development of companion diagnostics, and other diagnostic assay based designs to gain clinical insight or follow drug or metabolite reactions," said Shen Luan, Co-Founder and COO.

Berg Diagnostics has a unique combination of bioanalytical and omics technology platforms that catalyze pharmacodynamic analyses and monitoring of therapeutic targets and drug products in a high throughput manner.  The combination of cutting-edge instrumentation, a driven ecosystem of innovation with its sister companies, and industry-leading work force allows for excellence in diagnostics development.

"This represents a significant milestone for Berg Diagnostics; it demonstrates the hallmark commitment that Berg Pharma has to clinical practice.  Shen Luan's team is positioned to become an imminent market leader in molecular diagnostics in truly creating a result that physicians can employ in patient care.  There is no dearth of data in the industry but rather a dire need for correlation of molecular signaling to pathophysiology. Use of Interrogative Biology® from Berg Biosystems separates Berg Diagnostics from competition.  They are not just able to generate data but apply it to disease management," said Niven R. Narain, Co-Founder, President and CTO of Berg Pharma.

Berg Diagnostics has launched a novel clinical assay related to metabolic arbitrators such as Vitamin D - key to maintaining overall health. Sihe Wang, PhD, DABCC, FACB, Section Head and Medical Director of the Clinical Biochemistry Laboratory at Cleveland Clinic: "This accreditation status will also expedite the availability of novel biomarkers for patient care after appropriate validation."