The science of saliva.

Liver disease is among the most under-diagnosed chronic conditions in the United States. An estimated 100 million American adults have metabolic dysfunction-associated steatotic liver disease (MASLD), and approximately 9 million have already progressed to the more aggressive form, MASH, with clinically significant fibrosis. Yet despite the scale of the problem and the recent emergence of MASH-targeted therapies, real-world data show that fewer than 1% of at-risk patients today receive the assessments that current guidelines recommend.

The reasons are structural and will remain so regardless of the next therapeutic developed. First-line screening relies on blood-based scores that require patients to reach primary care, have the correct labs drawn together, and be correctly interpreted by clinicians who may not be trained in liver disease. Each step in this cascade compounds attrition. The patients who would benefit most from early detection are the ones least likely to receive it.

Saliva-based screening was designed to bypass this cascade. By moving the diagnostic into the settings where patients already are, Calaris's approach removes the access barriers that prevent today's screening pathway from reaching scale.

Saliva contains a rich and growing list of validated biomarkers across hepatic, oncologic, and inflammatory pathways. The challenge has historically been one of analytical sensitivity as biomarker concentrations in saliva are typically lower than in serum. This requires purpose-built assay chemistry to measure them reliably.

Calaris's platform addresses this through a multiplexed lateral flow architecture engineered to detect multiple low-abundance salivary biomarkers simultaneously. A proprietary algorithm combines the biomarker signals into a clear high-risk / low-risk classification, delivered at the point of care in minutes — without phlebotomy, without a needle, and without sending samples to a central lab.

Calaris holds an exclusive global license to the underlying biomarker technology, developed by a research team at an Australian academic partner institution. The lead product, SALCheck™ Liver, is built on biomarker discovery and validation work published in peer-reviewed journals, demonstrating strong correlation with elastography-confirmed fibrosis stage in patients with metabolic liver disease. The underlying science continues to evolve, and the Calaris platform is positioned to extend across additional indications as new salivary biomarkers are validated.