From The Stage
← Back to From The Stage
Natalie Smith
Posted by Natalie Smith BioAgilytix Insight, Regulatory Considerations

When Should Sponsors Use a CLIA Lab for Their Large Molecule Programs?

When Should Sponsors Use a CLIA Lab for Their Large Molecule Programs?

Clinical Laboratory Improvement Amendments (CLIA) is a set of federal standards that applies to all U.S. facilities or sites that test materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of health of, human beings. In short, if any test result is used to direct patient care, even in a clinical trial setting, then the test must be performed in a CLIA-certified laboratory.

There is still, however, confusion in the industry as to when a sponsor needs to engage a CLIA lab for their large molecule testing. It is a common misconception that all research phases of the biologic drug development process are excluded from CLIA oversight. There are actually many clinical trial areas where CLIA applies and they must be considered in the selection of an appropriate laboratory partner.

When is adherence to CLIA required?
To help guide your decision as to whether or not you need to work with a CLIA-certified lab partner, start with these questions:

  • Will your test results be used to determine a patient subject’s eligibility for a clinical trial?
  • Will the results be used to assign treatment to a patient subject?
  • Will you be using the results to assess individual outcomes of treatment?

If you answered ‘yes’ to any of these uses, then your testing will require patient-specific results reporting and therefore needs to be performed in a CLIA setting. Even if results are generated for a group of patients, if they are then used to assign individuals from the group to a specific treatment arm of a study, the test still falls under CLIA. Any test results returned to the patient subject must be provided by a lab with a CLIA certificate, which is why diagnostic testing facilities operate under CLIA.

A CLIA-certified laboratory must validate their tests to appropriate performance characteristics including precision, accuracy, sensitivity, specificity, and specimen stability, and perform periodic proficiency testing (PT) to assess assay performance against specific quality standards.

If you are not using test results for patient enrollment or surveillance immediately, a CLIA lab is not required, but remember that as your drug progresses through development you will likely need to report patient-specific results at various points throughout the process. If you place your assay in a CLIA-certified laboratory from the start, you will ensure it is developed and validated to CLIA standards for use through all clinical trial phases and following market approval.

CLIA for the rise of personalized medicine
It should be noted that CLIA certification is important for laboratories that are supporting precision medicines, where identifying clinical trials most likely to yield a positive outcome for a patient with the least amount of risk is crucial. Gene and cell therapy programs are a key example where testing for patient-specific clinical trial inclusion/exclusion is needed, but biomarker assays are also a key component to advancing any personalized biologic. They can yield smaller yet more effective sample sizes and a quicker clinical trial. However, any biomarker you are using to determine trial eligibility, assign treatment, or assess outcomes must be a robust assay backed by a solid quality management system (QMS). Quality management in a CLIA setting is conducted by regulating the process in phases: pre-analytic (specimen collection, transport, accessioning), analytic (the testing process), and post-analytic (reporting of patient results).

Additional assay-specific performance characteristics must also be evaluated for CLIA projects that use validated biomarker assays. This includes precision, accuracy, sensitivity, specificity for the reportable range of results specific to any CLIA assay (not general data); defined reference intervals for the population(s) to be tested; and specimen stability in the defined assay matrix.

Your CLIA Lab for Large Molecule Drug Development
Both of BioAgilytix’s U.S. labs in Durham, NC and Boston, MA are CLIA certified and able to handle biologic development programs from the preclinical phases to post-marketing surveillance. Through expert bioanalysis and adherence to these quality standards, we can provide patient-specific data that will help you make pivotal decisions regarding drug safety, dosing, and inclusion/exclusion criteria for patient enrollment in clinical trials. Speak with our scientists to learn how we can support every stage of your large molecule study with ensured CLIA compliance.

Share This