BOSTON, March 1, 2012 /PRNewswire/ -- 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 commitm
|SOURCE Berg Diagnostics|
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