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Laboratory-Developed Tests:
How FDA’s Proposed Regulatory Oversight Could Transform the Way Labs Create and Market LDTs—And What You Can Do to Reduce the Impact on Your Lab


Registration opens early next week—watch your email for details!


Your Presenters:

  • Joyce Gresko, Attorney, Alston & Bird LLP
  • Judi Smith, M.S., MT(ASCP), Vice President, In Vitro Diagnostics, Precision for Medicine    
  • Elaine Lyon, PhD, Section Chief, Molecular Genetics, Co-Medical Director, Pharmacogenomics, ARUP Laboratories, Associate Professor of Pathology, University of Utah School of Medicine

Virtually every clinical laboratory in the U.S. has to meet CLIA requirements, which are enforced by CMS. Laboratory-developed tests (LDTs) are also subject to CLIA standards, but typically have not had to go through an additional approval process by the FDA.
That may be about to change.
While CLIA requirements are critical to ensuring the highest possible standard of quality in laboratories, the FDA no longer believes that simply meeting CLIA requirements is sufficient to ensure the safety and effectiveness of these tests. The FDA believes that the growing number and variety of LDTs increases the potential risks associated with them and is considering a risk-based approach to regulating LDTs.
According to the FDA, there are 2,000 laboratories in the U.S. that perform more than 11,000 LDTs. If the FDA moves forward with its plans, all laboratories (including yours) will be subject to an entirely new development and approval process for tests they produce and use internally. Your lab will still need to comply with CLIA, but will also need to follow other requirements that could conflict with CLIA, and from an entirely different regulatory body. The additional costs and complexities of the new FDA guidance will likely affect the way you develop and market your LDTs—and your laboratory’s bottom line.
Your lab needs to be on top of the new guidance and be ready to comply when the FDA finalizes its plan to regulate LDTs. Good thing there’s a new webinar from Pathology Blawg that will provide you with the information you need to understand what the FDA is planning, how these plans might be implemented, and what penalties your lab could face if it isn’t ready to comply.
Find out how the FDA’s guidance could work in laboratories that develop LDTs when you attend “Laboratory-Developed Tests: How FDA’s Proposed Regulatory Oversight Could Transform the Way Labs Create and Market LDTs—And What You Can Do to Reduce the Impact on Your Lab” on Thursday, May 28, 2015. Listen as three expert panelists provide you with an in-depth review of the FDA’s draft guidance on regulating LDTs, and what it could mean for your lab.
First up is Joyce Gresko from Alston & Bird who will provide details on the draft guidance. You’ll learn what your laboratory will have to do to let the FDA know about its LDTs and what risk classifications will apply to current and future tests. You’ll also get a preview of what may be required for premarket review of “high-risk” and “moderate-risk” LDTs, what quality system regulations will be included, and what changes to expect to the way your laboratory can market and label its LDTs. You’ll come away with specific steps to help your lab prepare for the implementation of the FDA’s guidance.
Next up, Elaine Lyon from ARUP Laboratories and Judi Smith with Precision for Medicine will tackle some of the more serious problems that labs have with FDA’s plan for regulating LDTs. Dr. Lyon, who has more than 15 years of laboratory experience, will detail some of the top concerns she and her laboratory have about the FDA’s plan. Then Ms. Smith, with more than 30 years of experience working with the FDA on these kinds of issues, will provide a better understanding of what the FDA is thinking and will likely do related to its new oversight responsibilities. She’ll offer insights into the concerns raised by Dr. Lyon (and shared by many in the clinical laboratory testing community), and help allay some of the fears surrounding the FDA’s proposed regulation of LDTs.  
Whether you’re a laboratory director, business manager, compliance officer, or pathologist—anyone who needs to prepare for new FDA regulations of lab-developed tests—this is one webinar you can’t afford to miss.

For one low price—just $195 (through 05/15/15; $245 thereafter)—you and your entire team at one location can take part in this fast-paced, insightful webinar. Best of all, you’ll be able to connect personally with our speaker when we open things up for questions from the audience.

Here’s just some of what you’ll learn during this in-depth 90-minute webinar:
  • How the FDA’s regulatory framework for medical devices will be applied to LDTs.
  • How to address some of the biggest concerns that many laboratories have about the draft guidance.
  • Insights from an FDA expert about what the FDA says it will want vs. what the agency would be willing to accept. 
  • How long you will have to get ready before the FDA’s oversight plan has been finalized.
  • Which LDTs could be considered exempt and from which requirements.
  • How some of the FDA’s requirements could overlap or contradict CLIA requirement—and what you can do if that happens. 
  • What your lab can do now to prepare for the new FDA guidance, and the potential penalties you could incur if you don’t. 
  • Alternatives that industry leaders and members of Congress are promoting, and why you need to know what else is out there.
...and much more

Registration opens early next week—watch your email for details!


Distinguished Presenters

Joyce E. Gresko is an attorney at Alston & Bird, LLP where she is a member of the Health Care and Legislative & Public Policy Groups. She focuses her practice on healthcare regulatory, legislative, and compliance matters. Ms. Gresko’s clients include clinical laboratories, durable medical equipment suppliers, hospitals, health care professional associations, and other health care entities. She helps clients understand and resolve issues relating to Medicare and Medicaid payment and coding, federal and state fraud and abuse laws, effective compliance programs, and healthcare quality. 

Before she became an attorney, Ms. Gresko spent more than a decade as a public policy advocate and campaign professional. She worked for Democratic candidates campaigning for president, governor, U.S. Senate, and U.S. House. She also held leadership positions in advocacy organizations such as the Juvenile Diabetes Research Foundation (JDRF) and the Children’s Defense Fund. She has been selected by Super Lawyers as a 2014 Washington, DC “Rising Star.” 

Ms. Gresko received her JD from Georgetown University in 2008 and her BA from the University of Michigan.

Judi Smith, MS, MT (ASCP), is the Vice President of In Vitro Diagnostics and Quality within Precision for Medicine’s Translational and Regulatory Sciences Practice, which was established to provide value-added scientific and regulatory solutions for development, marketing authorization, regulatory compliance, and stewardship innovative healthcare products.

Ms. Smith has worked in the medical products regulatory, quality, and clinical trial areas for more than 30 years. In that time, she has been responsible for the regulatory submissions and approvals of a multitude of companion diagnostic assays, in vitro diagnostic products, and biological in vitro diagnostic assays, and for the establishment of quality systems for diagnostic products. She has also developed and implemented clinical trials for these products that were used to generate data for the regulatory submissions. As a member of the FDA/Industry Roundtable, Ms. Smith was awarded the FDA Group Recognition Award.

Ms. Smith has been President of the Association of Medical Diagnostics Manufacturers (AMDM) since 2006. This organization is dedicated to the in vitro diagnostic industry and provides educational programs with FDA’s Center for Devices and Radiological Health’s (CDRH) Office of In Vitro Diagnostics and Radiological Health (OIR). Ms. Smith is also on the board of the Regulatory Affairs Professional Society (RAPS) and the RAPS University as an in vitro diagnostic subject matter expert.

Ms. Smith received her BS from Temple University and her MS from Medical College of Pennsylvania.

Dr. Elaine Lyon, PhD, is Section Chief of Molecular Genetics and Co-Medical Director of Pharacogenomics at ARUP Laboratories. She is also an associate professor of pathology at the University of Utah School of Medicine. Dr. Lyon is board certified in clinical molecular genetics by the American Board of Medical Genetics. She has developed and implemented LDTs as part of the laboratory process following CLIA and CAP accreditation for more than 15 years. Her responsibilities also include evaluating new technology, ensuring quality of test results as well as interpreting molecular results in the clinical context.   

Dr. Lyon has served on committees and working groups to develop Laboratory Standards and Guidelines for the American College of Medical Genetics (ACMG). These include guidelines for next-generation sequencing and interpretation of sequence variants. She served on the College of American Pathologist(CAP)/ACMG Molecular Resource Committee, responsible for the CAP’s proficiency testing program in molecular genetics. She was the chair of the Clinical Practice Committee and the Professional Relations Committee for the Association for Molecular Pathology (AMP). In 2014, she served as AMP’s 2014 president and received its prestigious Jeffrey A. Kant Leadership Award for her contributions to and advocacy for the field of molecular pathology. 

Dr. Lyon received her PhD in medical genetics from the University of Alabama at Birmingham and continued with fellowship training in clinical molecular genetics at the University of Utah.


Registration opens early next week—watch your email for details!

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