The American Pharmacogenomics Association (APGxA) today issued a statement on the Food and Drug Administration’s (FDA) final rule regarding the regulation of laboratory-developed tests (LDTs).
Applauding Exemptions and Long-Term Implementation
The APGxA expresses its support for the FDA’s decision to exempt several categories of existing LDTs, including those already on the market and those developed within healthcare systems to address unmet medical needs. This exemption avoids a disruptive backlog in the approval process. The APGxA also commends the implementation schedule, which allows laboratories time to adjust to the new regulations.
Concerns and Recommendations
While broadly supportive, the APGxA identifies areas for improvement:
- FDA Staffing and Expertise: The influx of applications necessitates adequate staffing with expertise in diagnostic technology and laboratory operations.
- Turnaround Time and Predictability: A rapid and predictable approval process is crucial to maintain innovation and industry acceptance.
- Tailored Regulations: Adverse event reporting and quality system requirements should be specific to diagnostic tests, not simply copied from traditional device regulations.
- Differentiation by Test Type: Distinguishing between diagnostic testing and screening/surveillance testing in the approval process would be beneficial.
Industry Response and Looking Forward
The APGxA acknowledges the mixed reactions from industry associations. The final rule appears to be more accommodating to laboratories than originally anticipated, particularly for existing established labs.
The APGxA encourages collaboration between the FDA, industry, and other stakeholders to address the identified concerns and ensure a smooth transition for the benefit of patient care and diagnostic innovation.
About the American Pharmacogenomics Association
The American Pharmacogenomics Association (APGxA) is a scientific and professional organization focused on advancing the field of pharmacogenomics. Pharmacogenomics studies how a person’s genes affect their response to medications. By understanding an individual’s genetic makeup, healthcare providers can aim to prescribe medications that are more effective and have fewer side effects. APGxA works to achieve this goal through education, research, and collaboration.
Contact:
Celeste Miranda, President
hello@apgxa.com
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