SplashBIO Launches as Independent Platform Company to Tackle Alzheimer's Trial Screen Failures with Biomarker-Driven Pre-Screening
核心洞察
SplashBIO (搜索) has spun out from Splash Clinical (搜索) as an independent Platform-as-a-Service company focused on biomarker-driven clinical trial enrollment infrastructure.
The platform integrates blood biomarker tests and digital assessments into pre-screening to deliver biomarker-enriched, trial-ready populations to sponsors and sites.
In the A4 study of preclinical Alzheimer's disease (搜索), 71% of volunteers screened by amyloid PET were found ineligible, highlighting the costly screen failure problem SplashBIO (搜索) aims to address.
WAUWATOSA, Wis. — SplashBIO (搜索) Inc., a biomarker-driven enrollment infrastructure platform for clinical trials, announced its launch as an independent company on July 7, 2026. Spun out from Splash Clinical (搜索) — the enrollment organization where the platform was originally built and proven — SplashBIO now operates as a standalone Platform-as-a-Service company dedicated to transforming how participants are pre-screened before they ever reach a trial site.
The launch addresses one of the most persistent and costly challenges in clinical research: screen failure. In the landmark A4 study of preclinical Alzheimer's disease (搜索), 71% of volunteers screened by amyloid PET were deemed ineligible, according to findings published by Sperling et al. in JAMA Neurology (2020). SplashBIO (搜索)'s platform is designed to dramatically reduce this inefficiency by moving biomarker validation to the very front of the enrollment funnel.
A New Workflow for the Biomarker Era
SplashBIO (搜索)'s platform follows a unified workflow — Connect, Validate, Assess, Enroll — that integrates scientifically validated blood biomarker tests and digital assessments into pre-screening. The result is a biomarker-enriched, trial-ready population delivered to sponsors and clinical sites before patients travel for on-site evaluation.
"Biomarker science has transformed what's possible in clinical research, but enrollment workflows were built for a different era," said Matt Teuteberg, Founder and CEO of SplashBIO (搜索). "We built SplashBIO to bring a validated biomarker signal to the very front of the trial, before a patient ever reaches a site. Spinning out as an independent company lets us focus entirely on that infrastructure."
The company's Scientific Advisory Board Chair, John Harrison of Metis Cognition, emphasized the broader implications for trial access and inclusivity. "The push is on to widen access to early screening for Alzheimer's disease (搜索), and this new contribution from SplashBIO (搜索) is such a welcome development," Harrison said. "In a time where we need greater inclusivity in Alzheimer's disease clinical trial participation, remote cognitive assessment and mobile phlebotomy is an inspired approach to providing wider trial access and helping trial sponsors with their recruitment. The SplashBIO approach has real potential to reduce the very substantial screen failure rate, saving trial candidates unnecessary travel to study sites and trial sponsors' significant expense."
Built on an Established Partnership with C2N Diagnostics (搜索)
SplashBIO (搜索)'s platform builds on an existing partnership with C2N Diagnostics (搜索), first announced in March 2025, which integrates C2N's blood-based biomarker tests into the pre-screening workflow for Alzheimer's disease (搜索) trials. C2N provides high-resolution, mass spectrometry-based biomarker tests that support researchers in understanding disease mechanisms, identifying therapeutic targets, and conducting large-scale epidemiological studies.
"C2N Diagnostics (搜索) is proud to have been an early partner of SplashBIO (搜索) and congratulates the company on its launch as an independent platform company," said Dr. Joel Braunstein, CEO of C2N Diagnostics. "We look forward to expanding our collaboration as researchers continue advancing the understanding of Alzheimer's disease (搜索), improving diagnosis, and developing more effective treatments."
C2N assays have been utilized in over 200 Alzheimer's disease (搜索) and other research studies across the U.S. and globally, with more than 90,000 Precivity-related biomarker measures reported through peer-reviewed publications, and many additional manuscripts currently under review.
Initial Focus and Future Expansion
SplashBIO (搜索)'s initial therapeutic focus is Alzheimer's disease (搜索) and neurodegeneration, though the company's platform model is designed to extend to other biomarker-defined indications over time. Built by the team behind Splash Clinical (搜索), which brings more than 15 years of trial enrollment experience, SplashBIO positions itself as an infrastructure company purpose-built for the biomarker era.
The company will make its first appearance as an independent platform company at the Alzheimer's Association International Conference (AAIC) 2026, taking place in London from July 12–15. Sponsors, contract research organizations, and research institutions interested in the platform can meet the SplashBIO (搜索) team at the conference or request an introductory conversation through the company's website.