Newswise — Bethesda, MD, December 16, 2015: The Association for Molecular Pathology (AMP), the premier global, professional society serving molecular diagnostics professionals, has responded to FDA’s recently released report titled “The Public Health Evidence for FDA Oversight of Laboratory Developed Tests: 20 Case Studies” with a detailed analysis of the laboratory developed procedures (LDPs) mentioned in the FDA report. After a careful and thorough examination of the LDPs mentioned in FDA’s report, AMP concluded that FDA oversight would likely prevent few of the potential patient harms postulated by the Agency. Rather the Centers for Medicare & Medicare Services (CMS), which has statutory authority through the CLIA program, would have been more successful than FDA at addressing these potential problems.

“The 20 tests described by FDA are mostly a hodgepodge of outlier assays including tests that were never offered, tests for which comparable FDA assays perform poorly, tests for poorly defined disorders with psychologic components, and use of an FDA-approved test off-label. Also included are examples of tests that are widely regarded as major scientific breakthroughs and which are recommended in major medical guidelines. In one case FDA appears to imply that a manufacturer invented testing for a particular mutation, although laboratories in the United States had for many years been performing more flexible, more practical, and in many instances arguably superior procedures for the same analyte prior to introduction of the FDA-approved test,“ said Roger D. Klein, MD JD, AMP Professional Relations Chair. “That FDA could find only these dubious examples out of the many thousands of laboratory developed procedures (LDPs) that benefit patients each day, calls into question the Agency’s rationale for expanding its regulatory scope to include LDPs.”

In addition, AMP determined that for some assays FDA’s criticisms should not have been aimed at the procedures themselves, but at a small number of treating physicians who may have acted on results in a manner that was outside standard medical practice or failed to follow up a screening test with one that would provide a definitive diagnosis. However, AMP has long maintained that the involvement of board-certified professionals is critical to the development of accurate and reliable laboratory developed procedures (LDPs), as well as for correct utilization, accurate interpretation, and appropriate application of molecular test results. Insistence on the involvement of appropriately trained and qualified laboratory professionals, rather than FDA regulation, will best protect patients and ensure that they receive optimal testing services.

FDA’s concern about an ‘uneven playing field’ suggests that FDA may be more concerned with protection of competitors than patients. “FDA mistakenly advances the illusion that multibillion dollar IVD kit manufacturers are competing with, and are at competitive disadvantage to, LDP services provided by academic medical centers, hospitals, health systems, and independent laboratories across the country, and that it is the Agency’s job to ‘level the playing field,’” said Dr. Klein. “However, not only is there not an uneven playing field, FDA fails to recognize that service providers and manufacturers are not on the same field at all.”

FDA’s report doesn’t acknowledge the improvements many LDPs offer relative to FDA-cleared and approved tests. These LDPs include tests that detect key genetic mutations critical to therapy selection under circumstances in which use of FDA-approved assays can lead to incomplete or even false negative results and therefore failure of patients to receive potentially beneficial treatments. Often only LDPs designed and properly validated by molecular professionals to detect the mutation of interest are available to accurately analyze the patient specimen.

“The report released by FDA provides misleading information in an attempt to achieve a political end,” said Janina A. Longtine, MD, AMP Immediate Past President. “Clear and accurate information is needed to avoid a misinformed and alarmed public, especially as stakeholders are working together with Congress to achieve policy changes that will truly benefit patient care,” she added.

FDA pre-introduction review of LDPs will drastically disrupt patient care and not necessarily make patients any safer. The LDPs that have been cleared or approved by FDA have been submitted by a few esoteric, commercial laboratories that provide one or a small number of sometimes proprietary tests that are performed in extremely high volume for narrow clinical indications. Some of these companies have spent millions of dollars and built separate laboratories dedicated to performing the single FDA-regulated service. However, asking academic medical centers, hospitals and health systems, and cancer center laboratories to submit LDPs to FDA for pre-introduction approval is financially and administratively infeasible for these mostly nonprofit entities. Any such service for which FDA-clearance or approval is required will very likely cease to be offered, and patients will lose access to innovative and accurate laboratory testing procedures.

“AMP believes that the most reasonable and effective path forward is for Congress to insist that the CLIA program modernize, expand its current network of third party medical experts, and utilize scientific expertise from FDA and CDC rather than relinquishing its duties regarding the accuracy and reliability of LDPs,” said Charles E. Hill, MD, PhD, AMP President. “AMP strongly urges the Department of Health and Human Service and the Office of Management and Budget to perform a thorough, scientifically unbiased analysis of potential harms and benefits of FDA regulation of LDPs prior to embarking on a massive new regulatory program that would be enormously disruptive to health care and would likely have profound adverse consequences for patients across the country.”

View AMP’s analysis of the FDA reportView AMP’s analysis of the FDA report

ABOUT AMP:The Association for Molecular Pathology (AMP) was founded in 1995 to provide structure and leadership to the emerging field of molecular diagnostics. AMP's 2,300+ members include individuals from academic and community medical centers, government, and industry; including pathologist and doctoral scientist laboratory directors; basic and translational scientists; technologists; and trainees. Through the efforts of its Board of Directors, Committees, Working Groups, and members, AMP is the primary resource for expertise, education, and collaboration in one of the fastest growing fields in healthcare. AMP members influence policy and regulation on the national and international levels, ultimately serving to advance innovation in the field and protect patient access to high quality, appropriate testing. For more information, visit

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