Saliva-based diagnostics for the early detection of liver disease and head & neck cancer.

Calaris is developing point-of-care tests built on validated salivary biomarkers - designed to bring clinical-grade screening into settings where patients are most likely to be seen.

Most chronic diseases are detected too late. Not because the science isn't there, but because the screening pathway doesn't reach the patient.

Calaris is building a saliva-based diagnostic platform designed to remove the access barriers that prevent today's screening from reaching scale.
Three platform pillars

Rapid saliva tests that help assess risk and catch issues early

Leveraging validated biomarkers, multiplexing architecture, and AI/ML computational algorithms to generate risk scores for early triaging.

1

Non-invasive by design

Saliva collection takes seconds and requires no needle, no phlebotomist, and no specialized infrastructure. The friction that prevents routine screening disappears.

2

Engineered for the point of care

Designed for use in primary care or community health settings with results available in minutes, not days.

3

Built on validated science

Our platform draws on peer-reviewed biomarker research developed in partnership with an Australian academic institution, validated against established reference methods.

Three programs. One platform.

Near-term programs focused on hepatology and head & neck oncology.

Pioneering the next generation of saliva-based diagnostics to address urgent, unmet needs in chronic disease management.

Explore the pipeline
Lead program
Hepatology
MASLD/MASH

SALCheck™ Liver

A saliva-based point-of-care test for the detection and risk stratification of clinically significant liver fibrosis in patients with metabolic dysfunction-associated steatotic liver disease (MASLD).

Up to 100 million Americans are estimated to have MASLD, with 9 million of them having the progressive form, MASH. SALCheck™ Liver is designed to bring fibrosis screening into the community where patients are most likely to be seen, and move them to downstream care to potentially unlock access to new MASH-targeted therapeutics.

More about SALCheck™ Liver
Pipeline
Head & neck cancer

SALCheck™ Oral

A saliva-based screening test for head & neck cancers. Despite a clear clinical need, there is no population-based screening guideline and patients commonly present with advanced disease. SALCheck™ Oral is designed to identify high- risk patients in primary care and dental settings before symptomatic presentation.

SALCheck Liver saliva-based diagnostic test for liver fibrosis detectionSALCheck Oral saliva-based diagnostic device by Calaris Diagnostics
Three programs. One platform.

Near-term programs focused on hepatology and head & neck oncology.

Pioneering the next generation of saliva-based diagnostics to address urgent, unmet needs in chronic disease management.

Explore the pipeline
Lead program
Hepatology
MASLD/MASH

SALCheck™ Liver

A saliva-based point-of-care test for the detection and risk stratification of clinically significant liver fibrosis in patients with metabolic dysfunction-associated steatotic liver disease (MASLD).

Up to 100 million Americans are estimated to have MASLD, with 9 million of them having the progressive form, MASH. SALCheck™ Liver is designed to bring fibrosis screening into the community where patients are most likely to be seen, and move them to downstream care to potentially unlock access to new MASH-targeted therapeutics.

More about SALCheck™ Liver
SALCheck Liver saliva-based diagnostic test for liver fibrosis detection
Pipeline
Head & neck cancer

SALCheck™ Oral

A saliva-based screening test for head & neck cancers. Despite a clear clinical need, there is no population-based screening guideline and patients commonly present with advanced disease. SALCheck™ Oral is designed to identify high- risk patients in primary care and dental settings before symptomatic presentation.

SALCheck Oral saliva-based diagnostic device by Calaris Diagnostics
The team

A team of clinicians and operators behind Calaris

Led by a physician-founder with eight years in commercial diagnostics, supported by an advisory board drawn from US academic medicine, hepatopathology, pharma strategy, and global IVD commercial leadership.

Meet the team
Jim Chen, MD, MPH — Founder & CEO at Calaris Diagnostics
Calaris Diagnostics team member
Calaris Diagnostics team member
Pete Celano team Calaris
Calaris Diagnostics team member
Calaris Diagnostics team member
Calaris Diagnostics team or laboratory environment
Calaris Diagnostics team member

Built on peer-reviewed research with an Australian academic partner

Patents filed across three indications. Development underway with a UK-based contract development and manufacturing partner.

Get in touch for a deeper scientific discussion

Send a note and our team will respond to you as soon as possible.

Contact us

FAQs

How is SALCheck different from existing fibrosis or cancer screening tests?

SALCheck™ is a diagnostic platform built around saliva as its biological medium, with individual products developed for specific clinical indications. Each indication brings its own competitive landscape (eg blood-based scores and elastography in liver fibrosis, biopsy and clinical inspection in oral and oropharyngeal cancer), and SALCheck™ competes against those incumbents on a different axis. Rather than trying to outperform existing tests on raw analytical accuracy, SALCheck™ is designed to reach patients those tests miss. Today's screening pathways depend on patients reaching specialist care, dedicated equipment, or trained interpretation - barriers that prevent many from accessing care. SALCheck™ removes these barriers by collecting a saliva sample in seconds and delivering a result at point of care.

Why saliva as the diagnostic medium?

Saliva contains validated diagnostic biomarkers across hepatic, oncologic, metabolic, and inflammatory pathways - a remarkably rich and accessible biological matrix. What has historically limited its use in clinical diagnostics is analytical sensitivity. Biomarker concentrations are typically lower in saliva than in blood, which requires purpose-built assay chemistry to measure reliably. The SALCheck™ platform addresses this through diagnostic architecture engineered specifically for low-abundance salivary biomarker detection. Saliva is not a workaround for blood - it is a deliberately chosen matrix that allows clinical-grade screening to reach the settings where patients are most likely to be seen, without phlebotomy, scheduling, or specialist infrastructure.

Where is Calaris in the development process?

Calaris is in active development through early 2027, working with a UK-based contract development and manufacturing partner for its flagship product, SALCheck™ Liver. The development plan progresses through prototype build, analytical validation, and clinical performance studies in advance of planned regulatory submissions across multiple international jurisdictions including the US, UK, Canada, and Australia. Calaris is not currently selling products.

What's the company's regulatory strategy?

Calaris's flagship, SALCheck™ Liver, is being developed as a novel in vitro diagnostic intended for use at point of care. The regulatory strategy reflects that intent: designed for clearance in multiple jurisdictions with deployment in primary care and community settings as the commercial focus. More detailed regulatory information will be shared as submissions progress.

Is the underlying technology proprietary to Calaris?

Calaris holds exclusive global licenses to the underlying biomarker technology, developed by a research team at an Australian academic partner institution. Calaris also develops proprietary algorithms and reader technology on top of the licensed biomarker platform.

How can I work with Calaris?

Calaris is open to clinical, partnership, and research conversations. Clinicians interested in the science can reach out through our contact form. Partnership inquiries, including pharma collaboration, distribution, and translational research, are handled the same way. Please indicate the category of inquiry when you reach out and we will route to the right person.

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