Trust
Compliance & responsible development
How Kiluma Biosciences approaches research ethics, quality, data protection, and regulatory alignment as we advance the InterceptIQ™ platform.
Research ethics
Human biospecimen research is conducted under IRB-approved protocols with participating institutions and appropriate informed consent. We work only with samples and data obtained in accordance with those approvals.
Regulatory pathway
Our lead assay is under active development. Kiluma is preparing for validation under CLIA and CAP frameworks, and intends to pursue FDA engagement appropriate to the intended use as our program matures. Assays are investigational and not for clinical diagnostic use outside of research protocols.
Data protection
Study data is handled with role-based access, encryption in transit, and least-privilege controls. Sample identifiers used in research are coded and separated from directly identifying information wherever practicable.
Quality practices
We follow written laboratory procedures, versioned analytical pipelines, documented change control, and structured record-keeping to support downstream validation and regulatory filings.
Workforce conduct
All personnel operate under confidentiality obligations and internal policies covering scientific integrity, conflicts of interest, and responsible communication of investigational results.
Partner diligence
We evaluate academic, clinical, and commercial partners for scientific rigor, regulatory posture, and data-handling practices before entering agreements, and formalize expectations in written contracts.
Investigational use statement
Kiluma's assays and analytical pipelines described on this website are investigational. They are not cleared or approved by the U.S. Food and Drug Administration for diagnostic use, and are not offered as clinical laboratory services. Any use of Kiluma technology today occurs within research protocols with appropriate ethical oversight.
Handling of biospecimens and health information
When Kiluma receives biological samples or associated health information from collaborators, it does so under written agreements — including material transfer agreements, data use agreements, and, where applicable, business associate agreements — that define permitted uses, security expectations, retention, and return or destruction obligations. We do not solicit health information through this public website.
Scientific communications
We communicate scientific progress in a manner consistent with the current state of evidence. Forward-looking statements about performance, indications, timelines, and market opportunity are labeled as such and are subject to change as data matures.
Reporting a concern
To report a security concern, a suspected data-handling issue, or a compliance question related to Kiluma's website or business practices, email info@kilumabio.com. Please do not include patient-identifying information in your initial message.
Updates
This statement will evolve as our program advances into validation, laboratory accreditation, and regulatory submissions. Last updated: July 15, 2026.