The letter below was addressed and emailed to Senators Burr and Murray on May 21, 2022:
We at the independent and nonprofit Center for Genomic Interpretation (CGI) are writing in support of the FDA Safety and Landmark Advancement Act draft, specifically the VALID Act of 2022 (Subtitle C). CGI’s nonprofit mission is to encourage careful stewardship of clinical genetics, genomics and precision medicine. In our work at CGI we regularly uncover patient harming errors in laboratory developed tests (LDT). We believe many of these errors would be prevented if clinical genetic and genomic tests were regulated by the FDA. Systematic as well as sporadic sources of error are brought to our attention by clinicians, patients, and laboratory whistle blowers. We also discover laboratory errors through the laboratory selection assessment work we do for health insurance and pharma companies. Based upon our experience, we do not believe the precision medicine industry can continue through self-policing (e.g. CAP) alone without causing additional and increasing harm to patients. Thus, FDA oversight is needed for precision medicine to widely succeed.
CGI wishes to stress the importance of regulatory oversight over clinical laboratory testing because major medical decisions are made based on genetic and other diagnostic test results. The LDT loophole has been used for years by diagnostic testing laboratories to dodge independent review and verification of test performance. LDT status was originally intended for small volume tests for rare conditions, where only a handful of samples would be processed per year and meeting FDA approval or clearance requirements would be practically impossible. However, the LDT status loophole has been broadly used by the clinical laboratory industry to offer unvalidated and frequently inaccurate testing to a large portion of the population.
We commend professional organizations such as CAP, AMP and ACMG for their role in providing guidelines, education and checklist resources to help laboratories make quality improvements. Unfortunately, these tools have not been enough to protect patients from preventable harm. And sometimes these organizations are not transparent with clinicians and the public concerning some of the harmful weaknesses of genetic and genomic laboratories. Many professional organization members also make excuses when quality issues are published independently by brave clinicians and researchers [see appended references].
Allowances have historically been made for less accurate clinical tests when the tests originate from laboratories that lack sufficient resources to produce consistently accurate diagnostics with demonstrated efficacy. We believe that only laboratories with sufficient resources to develop accurate and reliable tests, and those that can transparently demonstrate that their tests are safe and effective, should be allowed to market tests for clinical use. We believe FDA oversight would create a safer-for-patients market environment, and that innovation towards safe and effective tests would continue. The market will adapt. It always does.
Because of the serious risk of harm to the many patients who receive poor clinical laboratory testing, we strongly support the VALID Act of 2022 to prevent the clinical laboratory industry from continuing to offer tests to patients without any independent review of safety or effectiveness.
Sincerely,
Dr. Julie EggingtonAbbreviations: LDT = Laboratory Developed Test, CAP = College of American Pathologists, AMP = Association for Molecular Pathology, ACMG = American College of Medical Genetics and Genomics
Appendix in the Attached Document: Supporting quotes and references