FDA Regulation of Molecular Diagnostics
Date: March 10, 2025
Time: 12 PM EST
Duration: 60 Minutes
Diagnostics based on linking the symptoms of a disease to specific proteins, DNA/RNA, or other biomarkers has become increasing common. Molecular diagnostics form the core elements of personalized medicine. The first molecular diagnostics tests to be used commercially were for infectious diseases, followed by molecular oncology tests. Currently there are molecular diagnostics for inherited disorders, cardiovascular disorders, and other disease areas. A Molecular diagnostics tests have a wide range of applications, including monitoring response to therapy, identification of individuals who are at increased risk of developing certain disorders, determining prognosis such as with cancer, personalized medicine applications, including pharmacogenetic tests such as drug metabolism tests to avoid adverse drug effects, and companion diagnostics to identify patients who will respond to a specific drug. Molecular diagnostics has emerged as a significant segment of the overall clinical diagnostics market.
FDA regulates molecular diagnostic tests in diverse ways from some requiring regulatory pathways as complex as Class III medical devices, while most others being approved as 510k devices or lab developed tests (LDTs). This seminar will discuss the current regulatory pathways for genetic and protein biomarker-based diagnostic tests with practical tips to navigate the regulatory approval based on the author’s extensive experience with such tests.
There is a lot of confusion regarding the process for obtaining approval for commercial use of molecular diagnostics by FDA and reimbursement by the payers. The development steps, testing requirements prior to approval, role of CMS and FDA in certifying the tests and testing location, and scientific basis for approval vary from test to test. There is very little guidance from the FDA stating its expectations from a given test leading to the regulatory pathways being customized on a case-by-case basis. This seminar will answers the above questions providing practical tips to comply with FDA’s requirements.
This seminar is intended for general instructions to all molecular diagnostic providers such as laboratories, clinics, physicians, hospitals, reimbursement experts, clinical trial users, and regulators who wish to have a better understanding of how FDA regulate such tests.
Areas Covered in the Session:
- Outline of FDA’s regulations governing molecular diagnostics
- Biomarkers and diagnostics from a device and drug perspective
- Challenges for genetic and protein based diagnostics
- FDA’s recommendations for assessing analytical and clinical performance such assays
- Transitioning molecular diagnostic technologies from basic research tools to market-ready medical devices
- The role for the FDA interactions in diagnostic Development
- Common issues with regulatory submission for molecular diagnostics
Who will benefit:
The following individuals or disciplines will benefit from attending this Webinar:
- Senior management of molecular diagnostic providers
- Project Managers
- Regulatory Vice Presidents, Directors and Managers
- Lab testing professionals
- Compliance professionals
- Auditors
- Attorneys – In-house or Outside Counsel
Speaker: Mukesh Kumar
PhD, RAC | CEO, FDAMap
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Webinar Fee
Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.
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Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.
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