Navigation Links
Berg Diagnostics Receives CLIA Certification and Launches Novel Vitamin D Assay
Date:3/1/2012

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). 

(Logo:  http://photos.prnewswire.com/prnh/20120301/CL62900LOGO )

"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."

About Berg Diagnostics
Berg Diagnostics, a member of the Berg Pharma group, is a Boston based molecular diagnostics company that offers high-throughput omics-based molecular profiling, biomarker validation, and regulated bioanalysis to accelerate development of molecular therapeutics and diagnostics. Armed with the state-of-the-art instrumentation platforms, the company serves to catalyze project end-points in therapeutic and biomarker development using the novel Berg Biosystems Interrogative Biology® platform.

For more information about Berg Diagnostics, please visit www.bergdiagnostics.com.


'/>"/>
SOURCE Berg Diagnostics
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. Rubicon Genomics and Agendia Sign Agreement for Use of TransPLEX® Whole Genome RNA Amplification Technology With Symphony™ Cancer Diagnostics
2. The butterfly effect in nanotech medical diagnostics
3. Accelerate Brain Cancer Cure and Exosome Diagnostics Collaborate to Advance Clinical Studies of Exosome Biofluid Molecular Diagnostics Technology in Brain Cancer
4. EUR 1.0 Million Grant Awarded to Exosome Diagnostics and Ludwig Maximilian University from German Federal Ministry for Education and Research to Develop Biofluid-Derived Exosome Diagnostics
5. ZyGEM to Provide its Unique DNA and RNA Extraction Technology to Middle East Biomedical Innovator Saudi Diagnostics Ltd.
6. Quest Diagnostics Reports Fourth Quarter 2011 Financial Results; Provides Guidance for 2012
7. Quest Diagnostics STRATIFY JCV™ First FDA Market Authorized Antibody-based Blood Test to Help Stratify PML Risk in Multiple Sclerosis Patients
8. Boulder Diagnostics Licenses Novel Rapid Detection Technology for Homocysteine and Related Compounds from Portland State University
9. India In Vitro Diagnostics Market Outlook to 2017- Clinical Chemistry Genetic Testing, Haematology, Histology and Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture
10. QIAGEN Gains Rights to Genomic Biomarkers for Lung, Brain and Other Cancers to Expand its Pipeline of Companion Diagnostics
11. Exagen Diagnostics Launches Cutting-Edge Lupus Diagnostic
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/11/2017)... HILLS, Calif. , Oct. 11, 2017  SkylineDx today ... (ICR) and University of Leeds ... risk-stratify patients with multiple myeloma (MM), in a multi-centric Phase ... University of Leeds is the sponsor ... and ICR will perform the testing services to include high-risk ...
(Date:10/10/2017)... ... October 10, 2017 , ... ... (ADC) therapeutics, today confirmed licensing rights that give it exclusive global access ... developed in collaboration with Children’s Hospital Los Angeles (CHLA). Additionally, an ...
(Date:10/10/2017)... ... October 10, 2017 , ... ... optimization firm for the life sciences and healthcare industries, announces a presentation by ... Francisco. , The presentation, “Automating GxP Validation for Agile Cloud Platforms,” will present ...
(Date:10/9/2017)... ... October 09, 2017 , ... ... of medical marijuana products targeting the needs of consumers who are incorporating medical ... takes place in Phoenix, Arizona. , As operators of two successful Valley dispensaries, ...
Breaking Biology Technology:
(Date:6/30/2017)... , June 30, 2017 Today, ... developer and supplier of face and eye tracking ... Featured Product provider program. "Artificial ... innovative way to monitor a driver,s attentiveness levels ... from being able to detect fatigue and prevent ...
(Date:6/14/2017)... IBM ) is introducing several innovative partner startups at ... between startups and global businesses, taking place in ... startups will showcase the solutions they have built with IBM ... France is one of the most ... increase in the number of startups created between 2012 and ...
(Date:5/16/2017)... , May 16, 2017  Veratad Technologies, LLC ( ... online age and identity verification solutions, announced today they ... Conference 2017, May 15 thru May 17, 2017, in ... and International Trade Center. Identity impacts ... and in today,s quickly evolving digital world, defining identity ...
Breaking Biology News(10 mins):