Diagnostics

IDSA Response to HELP RFI on LDT Reform

IDSA Comments on FDA Landmark Advancements Act

IDSA submits comments to Senators on the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022

IDSA Letter Re The Laboratory Access for Beneficiaries Act (PDF)

IDSA supports the introduction of The Laboratory Access for Beneficiaries (LAB) Act, HR 3584--bipartisan legislation to address the unintended consequences of the Protecting Access to Medicare Act (PAMA).

IDSA Response to FDA LDT Proposed Rule

ASM and IDSA Letter to OMB on LDTs

IDSA and the American Society for Microbiology (ASM) sent a letter to OMB and FDA outlining concerns with current and upcoming regulations on laboratory developed tests (LDTs).

IDSA-HIVMA Letter to CDC on Syphillis Lab Recommendations

IDSA submitted comments to CDC regarding the new laboratory testing recommendations on syphillis for the United States.

Breakpoints Letter to FDA

IDSA submitted a letter to FDA regarding its policy antimicrobial susceptibility interpretive criteria (i.e. breakpoints).

IDSA Comments to CMS Re CLFS Annual Public Meeting (PDF)

IDSA comments to the Centers for Medicare & Medicaid Services on recent reimbursement trends for clinical diagnostic laboratory tests and concerns about creating new payment codes for tests without evidence of unbundling or improper billing from the discussion at the annual CMS Clinical Laboratory Fee Schedule meeting.

IDSA Comments to CMS Re Diagnostics Reimbursement (PDF)

IDSA comments to CMS on recent reimbursement trends for clinical diagnostic laboratory tests as required by the Protecting Access to Medicare Act of 2014 (PAMA).

IDSA Comments Re Draft Diagnostic Accuracy and Innovation Act (PDF)

IDSA comments to FDA on the draft Diagnostic Accuracy and Innovation Act (DAIA) that builds on previous efforts to establish a modern framework for the regulation of laboratory developed tests (LDTs).

Joint IDSA HIVMA Comments to FDA on Reclassification of HIV and HCV Diagnostic Tests (PDF)

IDSA and HIVMA submitted joint comments to FDA in advance of a joint meeting of the Blood Products Advisory Committee and the Microbiology Devices Panel of the Medical Devices Advisory Committee on the reclassification of diagnostic tests for HIV and HCV from Class III to Class II.

IDSA Comments to CMS Re CY 2018 Clinical Laboratory Fee Schedule Test Codes Preliminary Determinations (PDF)

IDSA submitted comments to the Center for Medicare & Medicaid Services (CMS) 2018 preliminary payment rate determinations for clinical diagnostic laboratory tests.

IDSA Comments to FDA on Antimicrobial Susceptibility Test Devices (PDF)

IDSA submitted comments on the FDA public workshop on "Antimicrobial Susceptibility and Resistance: Addressing Challenges of Diagnostic Devices” as part of an ongoing dialogue generated by the 2016 FDA draft guidance, “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test (AST) Devices.” IDSA applauds FDA for engaging the diagnostics community on the scientific and regulatory challenges associated with developing AST devices and offers additional recommendations.

IDSA Letter of Introduction to ASPR Robert Kadlec (PDF)

IDSA letter of introduction to new Assistant Secretary for Preparedness and Response (ASPR) Dr. Robert Kadlec outlining IDSA priorities.

IDSA Introduction to FDA Commissioner Gottlieb (PDF)

IDSA wrote an introductory letter to recently confirmed US Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb offering its support and highlighting the need for new antibiotic research and development and infectious disease diagnostics.

IDSA Comments to FDA on Laboratory Developed Tests (LDT) Discussion Paper (PDF)

IDSA submitted comments to FDA on its January 2017 discussion paper on the proposed regulation of laboratory developed tests (LDTs). The paper synthesizes stakeholder feedback and outlines a prospective approach to regulation, and does not represent the formal position of FDA. IDSA is concerned that the proposed oversight framework would negatively impact patient access to infectious diseases diagnostic testing and has provided recommendations to improve oversight.

IDSA Comments on FDA Notice of Meeting on Microbiology Devices Panel (PDF)

IDSA comments to an FDA request for comments on the scheduling of a meeting of the Microbiology Devices Panel of the Medical Devices Advisory Committee to discuss reclassification of quantitative Cytomegalovirus (CMV) virus load devices from Class III to class II and appropriate initial classification for qualitative or quantitative viral load devices for Epstein-Barr virus (EBV), BK virus, JC virus, Human Herpesvirus 6 (HHV6), and Adenovirus infections.

IDSA Leads Response to FDA Guidance on Next Generation Sequencing (PDF)

IDSA led a joint letter with the Association for Molecular Pathology (AMP), the American Society for Microbiology (ASM), the Pan-American Society for Clinical Virology (PASCV), and the Association for Public Health Laboratories (APHL) in response to the FDA draft guidance on next generation sequencing (NGS). The comments highlight concerns with how FDA addresses assessing standards for NGS devices, how clinical validity is established for agnostic tests that have no pre-set target pathogen, and how FDA plans to assess regulatory grade databases for NGS tests.

IDSA Comments to FDA on Emergency Use Authorizations (PDF)

IDSA submitted comments to the FDA on its recent draft guidance that updates the EUA pathway. IDSA supported the updates that increase flexibility and clarity for sponsors seeking an EUA for diagnostic devices but also expressed concern on the requirement that EUA sponsors seek support from federal agencies responding to an outbreak, and offer recommendations to address these concerns.

IDSA Shares Evidence on Diagnostics for Transplant Viruses with FDA (PDF)

In response to IDSA concerns that its proposed regulation of laboratory developed tests (LDTs) may negative impact viral load testing for transplant patients, the Food and Drug Administration (FDA) has expressed a willingness to hold an expert panel meeting devoted to viral load testing for transplant-associated opportunistic viral infections. IDSA enthusiastically supports this meeting, and developed a letter with peer-reviewed evidence to inform the FDA’s efforts as well as a list of recommended subject matter experts to serve on the panel.

IDSA, ASM, and PASCV Letter to FDA on LDTs (PDF)

IDSA, ASM and the Pan-American Society for Clinical Virology urge FDA to consider the vital role of lab developed tests in rapidly diagnosing and appropriately treating infectious diseases.

IDSA Comments on CMS Proposed Clinical Laboratory Fee Schedule Rule (PDF)

IDSA responded the Centers for Medicare and Medicaid Services (CMS)’s proposed clinical laboratory fee schedule (CFLS) rule that outlines the implementation of a market-based reimbursement system, where applicable labs report costs and volumes of tests that are used to set nation-wide reimbursement levels. IDSA supported the system, but expressed concern that CMS will exclude almost all hospital academic labs and physician offices from reporting, leaving , most reimbursement data collection to high volume commercial manufacturers. IDSA highlighted that this may lead to reimbursement that are too low to sustain the routine use of local rapid testing by hospital laboratories.

IDSA Comments on CARB Diagnostics Challenge (PDF)

IDSA drafted comments to the National Institutes of Health (NIH) and the Biomedical Advanced Research Development Authority (BARDA) on the $20 million “Antimicrobial Point-of-Care Diagnostics Test Challenge.” IDSA strongly supported the prize and its potential to combat antibiotic resistance, and listed considerations around the types of diagnostics needed to achieve the challenge’s objectives.

IDSA Comments to FDA on Laboratory Developed Tests (PDF)

IDSA provided comments to FDA on its recent draft guidance to regulate laboratory developed tests (LDTs). IDSA agrees that LDT oversight is needed; however, it expressed major concerns that the regulatory framework, in its present state, would negatively impact patient access to infectious disease diagnostic testing and provided recommendations to improve oversight.

IDSA Responds to House Inquiry on the Regulation of Innovative Diagnostic Tests (PDF)

As part of its 21st Century Cures Initiative launched in May 2014, the House Energy and Commerce Committee requested input on the regulation of innovative diagnostic tests. IDSA's response stressed the importance of infectious disease diagnostics in patient care, and the need for flexible regulations to allow innovative test development to keep pace with evolving and emerging infectious diseases.

IDSA Joins Other Organizations in a Letter to FDA on Laboratory Developed Tests (PDF)

IDSA joined over 51 other organizations and stakeholders in urging the Food and Drug Administration (FDA) to consider issuing its proposed regulation of laboratory developed tests (LDTs) through notice and comment rulemaking. Given the scope of the proposed oversight, the procedures dictated by the notice and comment rulemaking process will enable the agency to achieve its regulatory goals without jeopardizing the current system of delivery of laboratory services for patient care.

IDSA Comments on FDA Draft Guidance: Balancing Premarket and Postmarket Data Collection for Medical Devices (PDF)

IDSA applauded the FDA on the agency's recent draft guidance on balancing premarket and postmarket data collection for medical devices. For diagnostics devices to unmet medical needs, IDSA supports premarket approval with greater uncertainty on device risks and benefits if post-approval data collection can then provide additional information about the diagnostic's efficacy safety in real-world settings.

IDSA Engages House 21st Century Cures Initiative (PDF)

In May, the House of Representatives launched its 21st Century Cures Initiative aimed at engaging stakeholders to develop policies that will help bring new drugs to market. In response to a request for input, IDSA highlighted the need for new incentives and regulatory changes to spur R&D for new antibiotics and rapid diagnostics as well as public health interventions to slow the rise of resistance.

AMA House of Delegates Approved IDSA Resolution on ID Diagnostics (PDF)

IDSA developed a resolution for the American Medical Association (AMA) House of Delegates (HOD) in support of policies to advance next generation ID diagnostics research, development, and appropriate use.  The proposal was submitted for consideration at the June AMA HOD meeting by IDSA Representative Dr. Michael Butera, and was approved.

Diagnosing Infection at the Point of Care: How Standards and Market Forces Will Shape the Landscape for Emerging Diagnostics Technologies

How Standards and Market Forces Will Shape the Landscape for Emerging Diagnostic Technologies

Diagnostics Reimbursement Improvements Enacted (PDF)

The Protecting Access to Medicare Act, signed into law on April 1, 2014, included key provisions to strengthen reimbursement for diagnostics tests, as championed by IDSA.