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Panel Discussion: The Current State of Laboratory Developed Tests (LDTS) and Implications of FDA’s Final Rule on the Future of LDT Testing
Program Speaker:
Karin A. Hughes, Ph.D.
Senior Vice President of Global Regulatory & Quality at Beaufort
Natalie J. Kennel, FRAPS, RAC-US, ASQ CQE & CQMgr
Founder NJK & Associates
Event Agenda:
DATE: Tuesday, 6 August 2024
TIME:
5:30 – 6:00 PM Light Dinner & Speed Networking
6:00 – 6:05 PM Welcome and Announcements
6:05 – 6:35 PM Topic Introduction lead by Karin Hughs
6:35 – 8:00 PM Panel Discussion and Q&A
LOCATION: This event is being offered both IN PERSON and VIRTUALLY. When you register, you will be able to choose how you will attend the event. No walk-ins allowed. Please register for this event by the registration deadlines.
If you register to attend IN PERSON, please join us at:
Neurocrine Biosciences
12790 El Camino Real
San Diego, California 92130
If you register to attend VIRTUALLY, you will receive the Zoom link 1-2 days before the event.
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Program Details
Within the clinical laboratory, most diagnostic tests are divided into two categories: in vitro diagnostics (IVDs) and laboratory developed tests (LDTs). Unlike IVDs, which are commercially produced and FDA-regulated, LDTs are developed internally by qualified laboratory directors, often to meet specific patient needs when no suitable commercial test exists. Currently, the Centers for Medicare and Medicaid Services (CMS) regulates clinical laboratories via the Clinical Laboratory Improvement Amendments (CLIA), while FDA regulates medical devices (including IVDs) under the Food Drug and Cosmetic Act (FD&C Act), exercising enforcement discretion over LDTs. In April, the FDA finalized a rule amending its regulations to make explicit that IVDs are devices under the FD&C Act, including when the manufacturer of the IVD is a laboratory. The rule includes a policy under which the FDA will phase out its enforcement discretion over LDTs within four years and includes targeted enforcement discretion policies for certain categories of IVDs offered as LDTs. This presentation aims to provide an overview of the current state of LDTs, FDAs recent final rule and the rule’s potential implications on the future of LDT testing. The presentation will be followed by a panel Q&A session.
Speaker Biographies:
Karin A. Hughes, Ph.D., is a highly experienced professional in the field of in vitro diagnostics (IVDs), currently serving as the Senior Vice President of Global Regulatory & Quality at Beaufort, a leading CRO specializing in IVDs. In her role, Karin provides clients with strategic planning and implementation of global regulatory programs from early development through product clearance and market expansion. In addition to her role at Beaufort, Karin is the Board President for the Association of Medical Diagnostics Manufacturers (AMDM) and is the AMDM’s nominated representative to the European Commission’s COMBINE project stakeholders reference group. In keeping with her commitment to ethical oversight and regulatory compliance in clinical research, she recently joined Univo Institutional Review Board (IRB) as a non-affiliated scientific board member. Prior to joining Beaufort, Karin worked for several large and start-up companies in regulatory, clinical and quality roles, mostly recently as Vice President Clinical & Regulatory Strategy for Astute Medical, Inc. (acquired by bioMérieux). Karin earned her Ph.D. in Chemistry from the University of Virginia and holds a B.S. from Hartwick College.
Natalie J. Kennel, FRAPS, RAC-US, ASQ CQE & CQMgr, founded NJK & Associates to bring her
practical perspective to medical device quality and regulatory affairs. With more than 35 years in industry, most devoted to medical devices, Kennel has hands-on experience with development and manufacturing as well as RA/QA and clinical roles in both major and start up medical device companies. She applies her expertise to the regulatory, quality and clinical needs of medical device companies. She has worked for both commercial laboratories and IVD companies and the interaction/effect of LDTs. She has set up quality systems for several different companies. She has provided on-going RA/QA for several companies. She has prepared several international medical device submissions including for Canada, Australia, Europe, Singapore, Taiwan, and WHO. She has set up quality systems and provided regulatory affairs support for a novel tissue bank. She is actively working with several companies to prepare for the MDR and IVDR and recently helping labs with the new FDA’s LDT regulation. Kennel published an article in AACC’s Clinical Laboratory News about the impact of the IVDR on clinical laboratories in 2020 and spoke at AACC virtual meeting on this topic. She holds a BS degree in Chemical Engineering from the University of Rochester. She can be reached at [email protected].
Registration Information:
No walk-ins allowed. Please register for this event by the registration deadlines.
- Click here to register for this event and select how you will attend the event.
Contact
Pricing Registration
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Registrant Type |
In-Person price |
Virtual price
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Member |
$20 |
$10 |
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Lifetime |
$20 |
$10 |
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Non-member |
$30 |
$20 |
Cancellation Policy
There will be no refunds for cancellations
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