Inanovate Secures FDA 510(k) Clearance for a Novel Lyme Disease Diagnostic
Client Background
Inanovate, based in Sioux Falls, South Dakota, is a biotechnology innovator focused on improving Lyme disease diagnostics. The company leverages patented Bio‑ID biomarker detection technology to deliver more accurate, accessible testing solutions.
Its flagship product, Lyme‑ID, is an FDA‑cleared Lyme disease diagnostic designed for direct‑to‑consumer use, enabling patients to collect a blood sample at home. As limitations in sensitivity, specificity, and interpretation continue to complicate Lyme disease diagnosis, Inanovate set out to deliver a differentiated solution that could meet both clinical and regulatory expectations.
Project Scope
As Lyme‑ID advanced through the FDA 510(k) pathway, Inanovate navigated a review process that required careful alignment between clinical data, performance claims, and regulatory expectations. As is common with novel diagnostic technologies, FDA review involved detailed questions related to:
- Interpretation of clinical performance data
- Performance considerations across defined patient groups
- Alignment between sensitivity and specificity claims, labeling, and intended use
Addressing these topics required not only statistical expertise, but also a clear understanding of how FDA reviewers evaluate diagnostic risk and the totality of evidence.
Inanovate partnered with NAMSA for statistical and FDA interpretive support, selecting the team for its experience supporting diagnostic submissions and its ability to provide practical, precedent‑based regulatory guidance. NAMSA brought a clear understanding of:
- FDA expectations for in vitro diagnostic performance
- How to interpret reviewer feedback in a regulatory context
- How to present data clearly, consistently, and in alignment with FDA decision‑making
Rather than taking a purely tactical approach, NAMSA worked collaboratively with Inanovate to support regulatory strategy and ensure responses remained focused, proportionate, and aligned with FDA priorities.
The Solution
NAMSA supported Inanovate across several critical phases of the review process:
FDA Feedback Interpretation
NAMSA helped interpret FDA questions to ensure responses addressed the core regulatory considerations without introducing unnecessary complexity or over‑interpretation.
Creative Statistical & Regulatory Problem Solving
As the review progressed, NAMSA assisted Inanovate in evaluating submission strategy options related to data presentation, wording, and intended use alignment. This included supporting discussions around how best to position existing clinical evidence in accordance with FDA expectations.
Submission Support & Documentation Review
NAMSA assisted with:
- Drafting and reviewing FDA response language
- Reviewing protocols and reports for clarity and consistency
- Ensuring statistical content aligned with regulatory context and risk‑based review principles
Providing real‑time guidance on which arguments FDA would—and would not—accept based on prior precedent
The Outcome
Inanovate successfully obtained FDA 510(k) clearance for Lyme‑ID.
Key results include:
- FDA 510(k) clearance of Lyme‑ID as a Lyme IgG diagnostic
- Readiness for U.S. commercial launch via a direct‑to‑consumer model
Lyme‑ID is now positioned to bring reliable, patient‑friendly Lyme disease diagnostics to market.
NAMSA played a critical role in our 510k approval process. By expertly guiding us through the statistical analysis requirements and related supporting rational that is so critical for FDA submissions. We are incredibly grateful for the collaborative efforts between our team and the regulatory experts at NAMSA to this end. With their insights we were able to engage effectively and very productively with the FDA. This partnership supported our pathway towards 510(k) clearance and we appreciate NAMSA’s invaluable insights throughout the journey!
David Ure Chairman & Founder at Inanovate, Inc.Meet Our Clinical Experts
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Chris Mullin, MS
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Tyson Rogers, MS
Principal Strategy Consultant, BiostatisticsView Bio -
Wendy Schroeder, BSN, CCRC/PM, CRCP
Principal Strategy Consultant, ClinicalView Bio -
Eric Bass, MS
Director, Global Data SciencesView Bio -
Candace McClure, PhD
Senior Principal BiostatisticianView Bio -
Lisa Thackeray, MS
Senior Principal BiostatisticianView Bio
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