OrisDX

Company overview

OrisDX is a Chicago molecular diagnostics company built on research from the University of Chicago. Its saliva-based platform uses next-generation sequencing and bioinformatics to assess genomic markers associated with oral cancer.

The company's Oro Lesion test is intended as an adjunct for evaluating adults with visible, indeterminate lesions in the oral cavity. Samples are collected through an oral rinse and sent to the company's laboratory for analysis. Oris Bridge supports kit activation, results delivery and referral coordination.

OrisDX opened an early-access program in August 2026 and announced a research and education partnership with the ADA Forsyth Institute in October 2026. Its current website invites providers to request kits; the earlier early-access announcement described delivery upon the upcoming commercial launch.

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Products & regulatory status How does MedTechIndex get this information?

Summary

Oro Lesion is a laboratory-based salivary test, with collection and results managed through Oris Bridge. OrisDX lists CLIA laboratory certification and CAP accreditation; its August 2026 announcement described early access ahead of commercial launch. ^[8][4][7]

Regulatory snapshot How to read this snapshot

U.S. FDA

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510(k) clearances

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De Novo grants

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PMA approvals

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Recall events

Latest recorded source review: 2026-11-02.

Scope: selected product families.

Commercial portfolio snapshot

No commercially marketed product portfolio has been established in the reviewed material.

Products with unconfirmed commercial availability

Oro Lesion ↗

Salivary-rinse DNA test using next-generation sequencing and bioinformatics as an adjunct to evaluation of adults with a visible, indeterminate oral lesion. Collection kits connect with the Oris Bridge results and patient-navigation workflow. ^[8][5][7]

Early access / kit requests offered

Early access / kit requests offered