Instrumentation Free Molecular Testing Device Detects TB at POC

25 million people annually, with nearly one in three cases undiagnosed. In high-burden, resource-limited regions, current diagnostics face serious challenges: the waxy, lipid-rich cell wall of Mycobacterium tuberculosis (MTB) resists portable lysis methods, gold-standard molecular tests demand costly infrastructure and skilled operators, and sputum collection often deters patients. Now, a new investigational prototype delivers point-of-care MTB detection without instrumentation, electricity, or lab infrastructure.

Seek Labs (Salt Lake City, UT, USA) has developed the MTB SeekIt prototype, built on its proprietary modular SeekIt platform. The test integrates lysis chemistry, extraction, amplification, and detection, all exclusively discovered and validated in-house. The development focused on solving the long-standing barrier of MTB cell wall disruption, achieving a functional prototype in just one quarter. The core innovation lies in a single-step lysis buffer that breaks down MTB cells in 15 minutes at room temperature.

The workflow begins with chemical lysis, followed by Seek Extraction, a membrane-based system that captures MTB DNA without lab tools, yielding more than 70% compared to leading spin-column kits. Next, Seek Amplification detects as few as 10 genomic copies in 30 minutes without thermal cycling. Finally, a molecular lateral flow assay (mLFA) provides visual results, which can be paired with a mobile app for digital analysis. Together, these steps create a fully instrument-free diagnostic test.

Internal validation confirmed that the MTB SeekIt test delivers accurate results in under 60 minutes. Importantly, it avoids reliance on heat, mechanical disruption, or expensive instruments, making it adaptable to low-resource settings. The company emphasizes that the prototype illustrates the flexibility and speed of the SeekIt platform, showing how similar assays can be rapidly created for other high-priority diseases.

Seek Labs is presenting the prototype at the 2025 Next Generation Dx Conference in Washington, D.C. The company is actively pursuing collaborations with ministries of health, TB-focused NGOs, and diagnostics distributors in regions like sub-Saharan Africa and Southeast Asia. Future efforts will focus on clinical validation, regulatory approval, and widespread deployment to close the global TB testing gap.

“TB diagnostics have long been limited by gaps in both infrastructure and innovation that have often meant severe consequences for patient care and public health,” said Jared Bauer, CEO of Seek Labs. “Our rapid, point-of-care SeekIt MTB test is designed to enable molecular-level detection in settings where access to equipment and electricity may be limited.”

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