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by IRWIN Z. ROTHENBERG, MBA, MS, CLS(ASCP) 

There may be circumstances when laboratories consider the option to modify an FDA-cleared or approved test system. These may be due to the specific needs of the population served, or based on cost/benefit analyses of instrumentation and reagent use; or based on the logistics of in-house testing capabilities.  CLIA allows clinical laboratories to modify their FDA-approved tests, and even to develop their own tests, known as laboratory-developed tests (LDTs), as long as they follow the requirements to validate the performance characteristics of their modified or in-house developed tests.

by IRWIN Z. ROTHENBERG, MBA, MS, CLS(ASCP) 

As we enter the third decade of the twenty-first century, the practice of medicine continues to undergo rapid change, led by advances in molecular diagnostics and genetics, enabling the practice of personalized medicine; advances in mobile and point of care testing technology, enabling medical care in remote as well as non-traditional settings; an ever-more intensely information-driven society where ready access to one’s personal medical information  is now expected, enabling and encouraging patient involvement  in their own healthcare; and finally, change is led by the growing realization of financial constraints due to demographic changes leading to the adoption of a value-based approach to healthcare delivery.