SplashBIO Launches to Combat Costly Trial Failures with Biomarker Tech

WAUWATOSA, Wis. – July 07, 2026 – A new technology company, SplashBIO Inc., launched today as an independent entity with a mission to solve one of the most expensive and time-consuming problems in modern medicine: clinical trial screen failures. Spun out from the veteran enrollment organization Splash Clinical, the new Platform-as-a-Service (PaaS) company is introducing a biomarker-driven infrastructure designed to overhaul how participants are pre-screened for studies, promising to accelerate the development of new drugs, particularly for diseases like Alzheimer's.

The challenge is immense. In some preclinical Alzheimer's trials, screen failure rates can be as high as 88%, meaning nearly nine out of every ten potential participants evaluated are ultimately deemed ineligible. This inefficiency creates a significant bottleneck, delaying vital research and inflating costs for drug sponsors.

“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, in a statement. “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 Multi-Billion Dollar Bottleneck

High screen failure rates are a systemic plague on clinical research. Across all therapeutic areas, studies show that failure rates average between 40% and 60%, but for complex neurological conditions, the problem is far more acute. The average screen failure rate for neurological studies has climbed to 57%, with preclinical Alzheimer's trials experiencing the most dramatic inefficiencies. The landmark A4 study, cited by SplashBIO, found that 71% of volunteers who underwent expensive amyloid PET scans were ultimately ineligible.

These failures carry a staggering financial burden. Industry analyses indicate that high screen failure rates can add over $1.2 million in costs per study, stemming from site activation fees, coordinator time, and patient reimbursements. With patient screening sometimes accounting for up to 70% of per-patient costs in Alzheimer's trials, the financial drain is enormous. The time cost is equally damaging, as recruitment delays can stall the entire drug development pipeline, where every day of delay can represent hundreds of thousands of dollars in lost potential revenue and, more importantly, a longer wait for patients in need of new treatments.

Screen failures often occur because a candidate's biological markers do not align with a trial's stringent inclusion criteria, or because of mismatches in disease stage or comorbidities. SplashBIO's model aims to address this problem head-on by moving the most critical validation steps to the very beginning of the recruitment process.

A New Blueprint for Enrollment

SplashBIO's platform is built on a simple yet powerful four-step workflow: Connect, Validate, Assess, Enroll. The innovation lies in front-loading the 'Validate' step with scientifically validated blood biomarker tests and digital assessments. Instead of bringing patients to a trial site for costly and invasive screening procedures like PET scans or cerebrospinal fluid tests, the platform identifies and qualifies a biomarker-enriched population remotely.

This process involves using targeted digital outreach to connect with potential participants. Those who express interest can undergo remote assessments, including cognitive tests and blood draws facilitated by mobile phlebotomy services. By integrating these validated biological signals early, the platform ensures that only the most suitable candidates are referred to clinical sites. This not only saves sponsors significant expense but also spares patients the burden of traveling to a site only to be disqualified.

“The push is on to widen access to early screening for Alzheimer’s disease, and this new contribution from SplashBIO is such a welcome development,” said John Harrison of Metis Cognition, who serves as Chair of SplashBIO’s Scientific Advisory Board. He noted that the use of remote cognitive assessment and mobile phlebotomy is an “inspired approach” that has “real potential to reduce the very substantial screen failure rate.”

Targeting Alzheimer's with Precision

Nowhere is this innovation more needed than in Alzheimer's research. SplashBIO's initial focus on neurodegeneration is anchored by a key partnership with C2N Diagnostics, a leader in blood-based biomarkers for brain health. The collaboration, first announced in March 2025, integrates C2N's highly accurate Precivity® blood tests into the SplashBIO pre-screening workflow.

C2N’s tests can detect the presence of amyloid plaques—a core pathology of Alzheimer's—from a simple blood sample with accuracy comparable to traditional PET scans. By using these tests upfront, SplashBIO can efficiently identify individuals with the specific biological profile needed for today’s precision-targeted Alzheimer's trials.

“C2N Diagnostics is proud to have been an early partner of SplashBIO and congratulates the company on its launch as an independent platform company,” said Dr. Joel Braunstein, CEO of C2N Diagnostics. “Through our partnership, C2N provides SplashBIO with high-resolution, mass spectrometry-based biomarker tests that enable researchers to better understand disease mechanisms, identify promising therapeutic targets, and conduct large-scale epidemiological studies that advance global public health.”

A Strategic Spin-Out in a Competitive Field

SplashBIO's launch as a standalone PaaS company is a strategic move to focus its resources on perfecting this new enrollment infrastructure. By operating independently from its parent organization, Splash Clinical, the company can dedicate itself entirely to scaling its technology platform. The PaaS model allows it to offer a specialized, flexible solution that can be integrated by various pharmaceutical sponsors and contract research organizations (CROs).

The company enters a dynamic market where AI-powered matching platforms and large CROs are also vying to improve trial efficiency. However, SplashBIO's specific focus on creating a unified workflow that combines validated biomarkers with digital pre-screening and patient support services carves out a distinct and critical niche.

While its initial focus is on neurology, SplashBIO has designed its platform for scalability. The company states its model can be extended to other biomarker-defined indications, positioning it to play a role in the broader shift toward precision medicine in areas like oncology, immunology, and cardiovascular disease. The company will make its formal debut at the Alzheimer's Association International Conference (AAIC) in London later this month, signaling its readiness to engage the global research community.