SBH Diagnostics

 
 
-
-

NEWS RELEASE

FOR IMMEDIATE DISTRIBUTION

 

SBH Diagnostics receives CAP (College of American Pathologists) Accreditation

         (Natick, MA)  April 28, 2015. SBH Diagnostics announced receipt of CAP Accreditation and will offer the Picosensitive C-Peptide and Highly Specific Glucagon Assays in the US and Canada for diagnostic testing.

CAP Accreditation is the College of American Pathologists certification, an internationally recognized program designed to go well beyond regulatory compliance. The program is based on rigorous standards that are translated into a detailed quality practice blueprint for Diagnostics Testing.

The quality of tests conducted by CAP Accredited labs is maximized through rigorous standards in areas such as quality control and assessment, personnel qualifications, test method verification, proficiency testing, safety and surveys and on-site inspections.

The Picosensitive and Glucagon ELISA Assays (licensed from Mercodia, SA), are highly specific, precise diagnostics blood tests and offers a low measuring range, not available with any other C-peptide or Glucagon assays on the market today. 

The C-peptide Assay allows many diabetic patients who may have been characterized as C-peptide negative based on the use of standard (less sensitive) methods to have their C-peptide levels accurately measured and this knowledge may affect treatment plans, inclusion in clinical trials, etc.

The Highly Specific Glucagon Assay shows very low cross-reactivity to the peptides such as oxyntomodulin, glicentin, mini-glucagon, GLP-1, GLP-2 and GRPP and the assay can be utilized as standardization for treatment assessments of diabetic conditions such as hypoglycemia.

 "With CAP certification, SBH Diagnostics continues  to provide comprehensive solutions for clients working in clinical environments," stated Raphael Nir, President, SBH Diagnostics, Inc. "We are committed to providing clinical researchers, physicians, and patients with C-peptide and Glucagon testing that will ultimately lead to better diagnoses and more effective treatments. Because we deliver validated tests through our own CAP laboratory, our partners have the ability to test clinical samples in a setting, with appropriate standard operating procedures, Quality Management Systems, and robust documentation. The company's laboratory operates under Good Laboratory Practice, and all personnel follow strict confidentiality guidelines and undergo a rigorous training program including Health Insurance Portablilty and Accountability Act (HIPAA) practices".

SBH Diagnostics is an innovative Contract Research Organization and CLIA/CAP Lab dedicated to providing LAB Developed Tests and reproducible biomarker analysis services. SBH Diagnostics provides a unique set of in-house CLIA/CAP Test Validation expertise and methodologies that includes:

  • Dedicated Lab infrastructure and ELISA based assay development
  • Sensitivity and Specificity validation technologies
  • PhD and Masters technologists and Regulatory Consultants on-staff
  • In-house Cell Assay Expertise and Cancer Diagnostic Biomarker development.

 

General information about SBH Diagnostics may be found at:
http://www.sbhdiagnostics.com
# # #


-
-
- - -


A CLIA certified, CAP accredited, Biomarker CRO.
(508) 650-6218 | Info@SBHdiagnostics.com