IVD 2026: What Changed, and What You Still Have to Do
Avania Fireside Chat • Live Panel + Q&A | Wednesday, September 9, 2026 • 1:00 PM ET / 10:00 AM PT
The LDT rule is gone, the reporting window that sets your 2027 Medicare rates has closed, and AI is on every panel. Two Avania IVD experts on what actually changed in 2026 and what it means for your next study.
2026 has been the most consequential year for US diagnostics in a decade, and the two developments that defined it moved in opposite directions.
The FDA rule that would have brought laboratory developed tests under device regulation was vacated by a federal court and formally rescinded, so the premarket question that dominated laboratory planning for two years is closed. The LDT-first sequence is openly viable again. Meanwhile the private payor data that sets Medicare Clinical Laboratory Fee Schedule rates for 2027 through 2029 has been reported, reductions of up to 15% per test resume in January, and MolDX still holds new molecular tests to a clinical utility standard before a claim is paid.
Between them sits the part most teams underestimate. FDA stepping back did not reduce the evidence burden on an LDT. It left that burden in CLIA, where the laboratory has to establish performance itself rather than verify a manufacturer’s. In 45 minutes of conversation plus live Q&A, Subo Perampalam and Eric Lam work through what changed, what did not, and what to decide before January.
What You’ll Walk Away With
| You’ll understand | Specifically |
|---|---|
| What the LDT vacatur actually changed | The sequence from the May 2024 rule to the March 2025 vacatur to the September 2025 rescission, what CLIA and state oversight still require, why kits are still devices, and why a vacated rule is durable ambiguity rather than a settled framework. |
| What you still have to do under CLIA | Establish versus verify, and why an LDT carries the larger burden. Personnel and certification requirements, ongoing quality control and proficiency testing, and where a Q-submission fits if FDA is the eventual destination. |
| Whether your next study is a bridge or a restart | Most labs run their own validations, and that is fine. The question is whether the protocol answers the right question with the fewest samples, and whether it holds up for the payer later rather than only the lab director now. |
| Your 2027 CLFS exposure | The pricing input is already submitted. Which codes sit in the affected set, what a reduction of up to 15% per year across 2027 through 2029 does to margin, and what can still be influenced. |
| What actually changes for an AI-enabled assay | The two questions to answer before you build, whether a predicate already exists, the new evidence axis when the model itself is under review, and where the PCCP bar sits. |
Your Speakers
SVP, Market Access & Reimbursement
Eric Lam, PhD
10+ years in IVD market access, built on a PhD in pharmacology and an NIH post-doctoral fellowship. Deep expertise in MolDX coverage, Advanced Diagnostic Laboratory Test applications, and novel coding strategy. Carries the payment half of the conversation.
Sr. Regulatory Consultant, IVD Expert
Subo Perampalam, PhD
IVD specialist with 20+ years in diagnostic product development and regulatory clearance, including product leadership at SQI Diagnostics and Nicoya Diagnostics. Carries the regulatory half of the conversation.
Built For:
- Regulatory affairs leaders at US diagnostics and molecular testing companies
- Laboratory directors and clinical operations leaders weighing what the LDT vacatur changed for them
- Market access, reimbursement, and commercial leaders modeling 2027 CLFS exposure
- Diagnostics founders and executives whose regulatory and reimbursement work sits with different teams
Reserve Your Spot
Free to attend. Complete the form and you’ll receive a confirmation email with your unique join link.