OAKLAND, CALIFORNIA — July 15, 2026 – SensTek Diagnostics today announced a phased validation study to evaluate its multi-target pathogen screening platform for potential blood-safety applications. As part of this effort, the American Red Cross Scientific Support Office will perform independent validation testing.

The evaluation will focus on the feasibility and performance of multiplexed molecular testing approaches in blood matrices for selected transfusion-transmissible pathogens, including Treponema pallidum, the causative agent of syphilis; West Nile virus; and blood-borne parasites such as Trypanosoma cruzi, which causes Chagas disease, and Babesia species.

The study is designed to generate scientific data that may inform future development, comparative performance assessment, and potential regulatory strategy. The Red Cross's role is limited to independent validation testing and does not constitute an endorsement, recommendation, procurement decision, clinical adoption commitment, or regulatory approval of SensTek's technology.

The validation program is expected to proceed in three phases. The first phase will involve controlled laboratory feasibility testing to assess how the platform performs with blood-based sample types before advancing to larger comparative studies. The second phase will include a small-scale comparative pilot against established gold-standard methodologies. The third phase will focus on robust, statistically significant data to support future development and potential regulatory submissions, as appropriate.

Manny Singh, CEO, SensTek Diagnostics:

"Independent validation is an essential step in determining how emerging molecular technologies may perform in complex, real-world sample types," said Manny Singh, CEO of SensTek Diagnostics. "We are pleased to have the American Red Cross Scientific Support Office contribute study-design input and independent validation testing as we evaluate the feasibility and performance of our multi-target platform in blood matrices. Our goal is to generate rigorous data that can inform future development, regulatory strategy, and potential applications in decentralized testing environments."

SensTek's platform is being evaluated for its potential to support rapid, multi-target detection across decentralized and near-point-of-care workflows. The company's broader development efforts are focused on expanding access to molecular and immunoassay testing in settings where speed, portability, and flexible assay deployment may be important, and high sensitivity and specificity is crucial.

Blood safety remains an area of ongoing scientific and public-health importance. By advancing independent evaluation of its platform, SensTek aims to better understand how multiplexed molecular approaches may contribute to future screening strategies for pathogens of concern.

About SensTek Diagnostics:

SensTek Diagnostics is a distributed diagnostics infrastructure company focused on advancing rapid molecular and immunoassay testing across decentralized settings. SensTek's MS2™ platform is designed to support detection of DNA, RNA, antibodies, and antigens, while its sBASE™ assay onboarding platform enables partners, licensees, and researchers to develop, validate, and deploy assays for emerging and established targets.

For more information:

www.senstekdx.com
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info@snstk.com
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SensTek Diagnostics Headquarters:

2044 Franklin St, Oakland, CA 94612