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Realizing the Dream of Precision Medicine by Preserving Access to Innovative, High Quality Tests

November 12, 2014
12:00 - 1:00 p.m.

B-369 Rayburn House Office Building
Washington, D.C.

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 Association for Molecular Pathology (AMP)

Registration: Please RSVP to Megan Anderson Brooks at mbrooks@dc-crd.com or 202.484.1100 by November 11, 2014.

Please join the Association for Molecular Pathology for a Congressional briefing highlighting the valuable role laboratory developed procedures (LDPs) play in precision medicine. Today, molecular (or genetic) based diagnostic tests enable physicians to tailor treatments for patients, reduce the likelihood of side effects, identify the causes of a disease, determine prognosis for cancer, and predict a person’s risk for developing a disease. LDPs are revolutionizing the way medicine is practiced and we’re only at the cusp of the possibilities. More, now than ever, it’s crucial to continue the investment in this emerging field and promote policies that will help realize the dream of precision medicine for all patients.

It is estimated that there are tens of thousands of LDPs in existence today used by as many as 11,000 labs across the United States. These specialized testing services play an essential role in medical decision-making by informing the diagnosis and care of patients. In October, the FDA issued a draft guidance indicating that the agency plans to begin regulating all LDPs, which it refers to as laboratory developed tests (LDTs). If the guidance is finalized, over the course of nine years, many labs will have to submit applications for premarket review for thousands of high and moderate risk LDPs if they wish to continue offering them to patients. Molecular pathologists are not manufacturers and complying with this proposed policy will not only drain their limited resources devoted to patient care, but also potentially subject them to the medical device tax, FDA user fees, product liability laws, and more. Of even greater concern, the FDA proposed policy could potentially stifle innovation by not allowing modifications to already approved or cleared LDPs, essentially freezing those tests in time.

On November 12th at 12 PM in B-369 Rayburn, please join AMP for a briefing to learn about how professionals in molecular pathology develop, validate, improve, and interpret LDPs, the proposed FDA framework for regulating LDPs, and its implications for patients, physicians, and the healthcare system.

Speakers include:

  • Dr. Aaron D. Bossler, Director of the Molecular Pathology Laboratory and the Molecular Genetic Pathology Fellowship at the University of Iowa College of Medicine, will review how LDPs are currently developed and the evolving regulatory landscape proposed by FDA.
  • Marianne Clancy, Executive Director, HHT Foundation International, will give a patient’s perspective of the value of genetic testing.
  • Dr. Elaine Lyon, President of the Association for Molecular Pathology, Medical Director of Molecular Genetics and Genomics, and Co-Medical Director of Pharmacogenomics at ARUP Laboratories, will discuss how LDPs are used to inform decisions associated with the diagnosis and treatment of rare, inherited disorders.
  • Dr. Janina Longtine, President-Elect of the Association for Molecular Pathology and Vice-Chair of Molecular Pathology and Genetics at the Mount Sinai Hospital, will speak to her experiences using LDPs in the diagnosis and treatment of cancer.
  • Dr. Roger Klein, Medical Director of Molecular Oncology at the Cleveland Clinic, will discuss the policy implications of FDA’s draft guidance on the ability to access and develop new LDPs.

This event complies with ethics and gift rules.

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