As an already fully functioning good laboratory practices (GLP) operation, MD Biosciences has recently achieved a new stage of value through CLIA certification for our high quality-testing services in the clinical and diagnostic arenas. CLIA or the Clinical Laboratory Improvements Amendments was put in place at the federal level to ensure a high level of laboratory testing. Therefore, clients can be assured that MD Biosciences meets these high quality standards and feel confident that their samples will be handled with the utmost technical and professional care to obtain reliable results.
Highlighted CLIA Services: Cancer Mutational Testing
For our initial CLIA compliant test offering, we emphasize our cancer mutational testing that can identify patients who would best benefit from particular targeted drug therapies. More specifically, cancers such as lung cancer (EGFR), skin cancer (melanoma-BRAF) and colorectal cancer (KRAS) are all known to have genetic mutations that make the tumors sensitive to certain therapeutics. At MD Biosciences, our clinical laboratory provides the necessary FDA approved testing for these genetic mutations, allowing oncology physicians the abilityto most effectively treat their patients. Our services will also include identification of gene modifications, such as methylation that are known to be important in the regulation of the abnormal tumor growth (neoplasms).
What Does CLIA Entail?
CLIA outlines specific requirements and regulations that laboratories must comply with to achieve and maintain certification. These requirements/regulations encompass all aspects of clinical laboratory operations, which are broken down into four broad categories – general laboratory operations, pre-analytical, analytical, and post-analytical test phases. General laboratory operation regulations focus on everything from facilities, to administration and personnel management and creation of a total Quality Management System (QMS). Pre-analytical regulations address all aspects of laboratory operations before sample analysis such as specimen collection, shipment, storage, etc. Analytical regulations include all aspects of laboratory operations during sample analysis. Lastly, post-analytical regulations address laboratory operations after sample analysis, including result analysis, result reporting, and record archiving. As MD Biosciences complies with all of these regulations, clients can have confidence in our results. Click to edit your new post...
