The evaluation will assess variant classification, reclassification detection and pilot readiness, with early findings presented at HITLAB’s Innovators Summit in December
NEW YORK, September 30, 2026 – HITLAB today announced a partnership with SerenityGx to independently evaluate the company’s AI platform, designed to help genetics professionals interpret genetic findings and identify when previously reported results may warrant re-evaluation as scientific evidence evolves. HITLAB will test the platform’s performance, review SerenityGx’s existing validation studies, and develop a framework for prospective pilot studies with health systems and clinical laboratories. Findings from the evaluation will be publicly reported to provide hospitals and other stakeholders with evidence they can use to assess the technology.
When a genetic test identifies a variant, qualified experts determine whether the available evidence supports a benign, pathogenic or uncertain classification using established frameworks such as American College of Medical Genetics and Genomics (ACMG) and the Association for Molecular Pathology (AMP) guidelines. But that interpretation reflects the evidence available at a particular point in time. New publications, populations data, functional evidence or family data can change the strength of evidence surrounding a variant months or years later.
For health systems, the challenge is therefore not only interpreting genetic results when they are first reported. It is determining when new evidence changes what is known, which historical patients may be affected, and when a result should be brought back to an expert for review.
SerenityGx is designed to support that longitudinal workflow. The platform merging evidence, organizes it against ACMG/AMP criteria, identified variants that warrant re-evaluation, and provides genetic professional with the underlying evidence and reasoning supporting each recommendation. Final classification decisions remain with qualifies experts.
Genetic testing has moved rapidly into mainstream case, creating an eexpanding population of patients whose results may need to be revised as scientific evidence changes. At the same time, the volume of genomic literature and variant-level evidence continues to grow, making systematic reassessment increasingly difficult to manage through manual workflows alone.
AI creates an opportunity to make that longitudinal surveillance scalable. But tools operating this close to clinical decision-making require more than technical promise. Health systems need independent evidence of performance, transparency around how recommendations are generated, and clear validation pathways before incorporating them into clinical workflows.
“There’s no shortage of promising AI in genetics. What’s missing is evidence,” said Dr. Stan Kachnowski, Chair of HITLAB. “Hospitals won’t adopt a tool because of a good demo. They want to know how it was tested, what it got right, where it falls short, and who checked the work. SerenityGx keeps experts in charge of the decision, and that’s the right starting point. Our job is to test it honestly and report what we find.”
“A genetic result shouldn’t be frozen on the day it’s reported,” said Heidi Wagner, CEO and Co-Founder of SerenityGx. ” Genomic medicine in increasingly longitudinal; what we know about a patient’s result today may not be what we know about it five years from now. Health systems need infrastructure that can keep pace with the evolution- identifying when the evidence changes, determining which patients may be affected, and bringing the right cases back to experts for review. SerenityGx was built to make that possible at scale. Our internal validation has given us a strong foundation, and HITLAB’s independent evaluation is an important next step toward prospective health system pilots.
Independent testing. HITLAB will test how accurately the platform classifies genetic variants against [reference standard]. It will also test whether the platform correctly flags results that need to be reclassified when new evidence appears, and whether it avoids unnecessary alerts.
Review of existing data. HITLAB will examine SerenityGx’s three internal validation studies, compare what each found and where each fell short, and summarize what the evidence shows and what it doesn’t yet show.
Pilot study plans. HITLAB will design pilot studies for health systems and clinical labs, defining what should be measured before the platform is used in routine care.
Published findings. HITLAB will publish a white paper through its channels. Early findings will be presented at the HITLAB Fall 2026 Innovators Summit, December 1–3 in New York City.
Learn More about
About SerenityGx
SerenityGx is an AI-driven genomics company that helps health systems, clinical laboratories and care teams keep genetic test results current as scientific evidence evolves. Its platform monitors emerging evidence, supports re-evaluation of variant classifications in alignment with ACMG/AMP standards, and helps identify previously tested patients whose results may warrant expert review. SerenityGx is designed to make longitudinal genomic surveillance more scalable while keeping qualified professionals in control of final classification decisions. The company’s leadership brings together expertise in clinical genomics, genetic counselling, medicine and healthcare operations.
About HITLAB
HITLAB is a New York City-based health innovation and technology research organization dedicated to improving health outcomes through rigorous, independent research. Working across academia, healthcare, government, and industry, HITLAB evaluates emerging health technologies to ensure they deliver meaningful value in real-world clinical settings.
Share the article:
