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September 12, 2018

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IDSA Intensifies Efforts to Preserve Patient Access to In Vitro Diagnostics

The House Energy & Commerce Committee is considering the draft Diagnostic Accuracy and Innovation Act(DAIA), a bill that would initiate Food and Drug Administration (FDA) regulation of laboratory developed tests (LDTs). On Aug. 29, FDA and Congress held a stakeholder meeting to discuss the draft legislation. IDSA member Gregory Storch, MD, FIDSA attended to further explain the ways in which LDTs are used in ID patient care and emphasize that continued access to ID LDTs is essential for academic and public health laboratories to rapidly respond to the need for new diagnostics. Please add your voice to this important conversation by using this action alert to educate your congressional representatives about the critical roles ID LDTs play in patient care and public health.

As currently drafted, the bill would require that many LDTs be submitted to the same FDA premarket approval process as commercial tests, an unaffordable and inappropriately burdensome process for academic medical centers and hospital laboratories. Last month, FDA submitted a technical assistance document on DAIA that would further reduce regulatory eligibility for low- and moderate-risk ID diagnostics with no evidence of harm to patient care. The proposed regulations inappropriately target transplant medicine, where LDTs have become the standard of care, and severely limit the availability of tests for rare infectious diseases, emerging diseases, and unmet needs.

IDSA is deeply concerned about any congressional legislation that could curtail innovation or patient access to lifesaving testing, and we will continue to work with Congress, federal agencies and our stakeholder partners to advocate that any new policies regarding the oversight of laboratory test approval preserve access to high quality diagnostic tests that improve the management and outcomes of life-threatening infectious diseases.

If you would like to learn more about IDSA’s work on this issue or share feedback on how the draft DAIA legislation may affect your practice, laboratory or institution, please email jlevy@idsociety.org.

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