LDT including CDx; CLIA versus FDA's Authority

Why Should You Attend:

The Clinical Laboratory Improvement Amendments (CLIA) program regulates laboratories that perform testing on patient specimens in order to ensure accurate and reliable test results. The FDA regulates manufacturers and devices to ensure that devices, including those intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, are reasonably safe and effective.

When it comes to CLIA-regulated clinical laboratories, there is always a big deal of confusion on the role of each regulatory authority in FDA-approved test/device and Laboratory Developed Test (LDT) (home-brew assays). The companion diagnostic (CDx) approach, an in vitro diagnostic (IVD) device that provides information that is essential for the safe and effective use of a corresponding therapeutic product, adds another layer of ambiguity in relation to its development, analytical validation, clinical qualification, approval and post-approval application.

This webinar will explain the regulatory path of a universal IVD device and LDT. It will discuss laboratory requirements to perform a diagnostic test on human samples.

Areas Covered in the Webinar:

• Classes of tests used in clinical laboratory
• Regulatory paths for approval of a universal IVD device and LDT (standalone or as a CDx)
• Laboratory requirements to perform a diagnostic test on human samples
• Analytical validation or verification of FDA-approved IVD kit or LDT
• CLIA vs FDA authority

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

• Pharmaceutical company, CRO, IVD manufacturer , or reference lab building capabilities in CDx
• Pharmaceutical company-owned, CRO, reference, or hospital-based clinical laboratory providing tests for clinical trials
• Reference or hospital-based clinical laboratory providing tests as standard of care
• Startups IVD manufacturer seeking FDA approval for an IVD

Instructor Profile:

Dr. Abdel Halim, PharmD, PhD, DABCC, FACB, VP of research and quality at DrugScan and is the founder and president of Biomarkers and Diagnostics Consultation. Dr. Halim has been promoting the proper utilization of biomarkers in drug development and patient management for decades. Abdel is recognized world-class thought leader in biomarker, personalized medicine and diagnostics with a unique vision on the potential utilities and limitations of biomarkers in drug development and patient management. He has 25+ years of experience in different aspects of biomarkers; discovery, development, qualification and applications, and extensive expertise in different technologies and platforms; from point-of-care devices till next-generation sequencing. Abdel led efforts to develop and qualify assays for more than 600 LDT and utilized them for patient management and close to 100 PI-PIV clinical trials, led efforts on numerous companion DX programs and has a track record of multiple FDA 510K approvals of IVD.

Abdel is one of four lab professionals in the USA who are triple certified by the American Board in Clinical Chemistry, Molecular Diagnostics, and Toxicology, authored more than 60 articles and delivered approximately 80 presentations and keynote speeches on biomarkers, translational medicine, personalized medicine and CDx. He has been serving as a KOL on numerous public and governmental advisory panels on drug and diagnostic developments, and he is a member of more than 20 Clinical and Laboratory Standard Institute (CLSI) committees to establish guidelines promoting quality in clinical laboratories and diagnostics worldwide.

Topic Background:

No doubt that laboratory results play a major role in guiding daily clinical decisions in patient management. The high costs incurred when drugs fail during clinical trials has prompted interest in laboratory tests as indicators for progress of disease, effect of therapeutic interventions, and/or drug-induced toxicity. For the applications of a laboratory test in patient management or as a diagnostic test in clinical trials, the test should be reliable and used under regulated environment.

A clinical laboratory can utilize an FDA-approved device or develop and validate an assay in-house. The FDA defines a Laboratory Developed Test (LDT) as an in vitro diagnostic test that is manufactured by and used within a single laboratory (i.e. a laboratory with a single CLIA certificate). LDTs are also sometimes called in-house developed tests, or “home brew” tests. Similar to other in vitro diagnostic tests, LDTs are considered “devices,” as defined by the FDA, and are therefore subject to regulatory oversight by FDA.

When a laboratory develops a test system such as an LDT in-house without receiving FDA clearance or approval, CLIA prohibits the release of any test results prior to the laboratory establishing certain performance characteristics relating to analytical validity for the use of that test system in the laboratory’s own environment. This alternative route is not applicable to companion diagnostics (CDx) where a test is developed for a specific drug and specific indication.

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