HNKlear: Saliva-Based Diagnostic Platform Advances Toward Clinical Use in Head and Neck Cancer
Key Insights
Dr. Shi-Long Lu's HNKlear (search) saliva-based diagnostic platform for head and neck cancer (search) is advancing toward clinical use for recurrence monitoring and companion diagnostics.
The technology, supported by NIH UH2/UH3 grant funding and CU Anschutz's SPARKee program, is undergoing rigorous analytical and clinical validation.
During the COVID-19 pandemic, the underlying saliva technology was successfully adapted into an extraction-free, high-throughput PCR testing platform.
A saliva-based diagnostic platform originally conceived for head and neck cancer (search) detection is moving closer to clinical application, driven by the translational research efforts of Dr. Shi-Long Lu at the University of Colorado Anschutz Medical Campus (search). The platform, called HNKlear (search), is being validated for recurrence monitoring and the development of companion diagnostics aimed at guiding precision cancer care.
The innovation builds on Dr. Lu's earlier experience during his postdoctoral training at Case Western Reserve University, where he contributed to stool DNA testing research that ultimately helped pave the way for Cologuard (search), the first noninvasive molecular screening test for colorectal cancer (search). "Seeing how a scientific discovery could be translated into a clinically impactful diagnostic tool sparked my interest in innovation," Dr. Lu said. When he later established his independent research program in head and neck cancer (search), developing a saliva-based diagnostic test became, in his words, "a natural extension of that experience, leveraging the anatomical accessibility of the disease site to pursue a noninvasive approach for early cancer detection."
From Early Support to NIH Validation
HNKlear (search) was selected as one of the first SPARKee projects by CU Anschutz Innovations, a designation that provided early-stage support critical to the platform's development. Additional backing came from the Colorado State, the university's Cancer Center, and the Cancer League of Colorado. These combined resources enabled Dr. Lu's team to secure an NIH UH2/UH3 grant, a funding mechanism specifically designed to support the rigorous analytical and clinical validation of promising biomarkers.
The team is now advancing the platform toward clinical use, with a focus on two primary applications: monitoring patients for cancer recurrence and developing companion diagnostics that can inform precision treatment decisions.
Pandemic Pivot Demonstrates Platform Versatility
During the COVID-19 pandemic, the underlying saliva-based technology was adapted to create an extraction-free, high-throughput PCR testing platform with an ultrafast turnaround time. This pivot enabled Dr. Lu's company to become one of Colorado's largest COVID-19 testing providers. "This experience reinforced that innovation requires flexibility, creativity, and the willingness to apply existing knowledge in new ways," Dr. Lu reflected.
A Culture of Translational Collaboration
Dr. Lu credits the collaborative environment at CU Anschutz as a key enabler of the work. "What motivates me most is bridging the gap between research discoveries and clinical impact," he said. "By combining innovative science with collaborative, patient-centered research, I hope to develop solutions that advance our understanding of cancer and translate into better diagnostic tools, treatments, and outcomes for patients."
He also highlighted the leadership of Dr. Yuri Agrawal, Chair of the Department of Otolaryngology–Head and Neck Surgery, describing her as "a strong advocate for innovation, providing the support and vision that enable faculty to pursue impactful ideas and transform them into clinical advances."
Looking ahead, Dr. Lu envisions a more seamless pathway for innovative ideas to reach patients. "Many faculty members generate groundbreaking discoveries, but translating these discoveries into clinical applications requires resources, expertise, mentorship, and connections across research, industry, and healthcare," he said. His advice to colleagues with early-stage ideas: "Do not wait until the idea is perfect before sharing it. Engage with your colleagues, mentors, and CU Anschutz innovation team early."