INOVIQ Signs Agreement with Sonic Healthcare to Advance EXO-OC Ovarian Cancer

Biotechnology

INOVIQ partners with Sonic Healthcare USA to validate its EXO-OC ovarian cancer test, advancing a potential US commercialisation pathway.

Imelda CottonJournalist · 1 min readIn this storyASX:IIQIn briefAt-a-glance3 takeaways

• 01INOVIQ taps Sonic USA to validate EXO-OC.
• 02Sonic may licence the test as an LDT after validation.
• 03Program targeted for completion by early 2028.

INOVIQ (ASX: IIQ) has entered into a validation and licence option agreement with pathology provider Sonic Healthcare USA allowing it to transfer activities needed to optimise and validate its EXO-OC ovarian cancer early detection test.

The agreement grants Sonic a licence to transfer, optimise, and validate EXO-OC at its advanced molecular diagnostics laboratory in New York state, providing it with an option to pursue a future licence to offer EXO-OC as a laboratory developed test (LDT), subject to successful validation and commercial discussions.

The deal strengthens INOVIQ’s investment proposition by partnering EXO-OC with a leading US laboratory, establishing a clear pathway toward LDT validation and creating a potential route to earlier market entry, patient access, and revenue generation in the nation’s large diagnostics market.

Alongside Sonic’s work, INOVIQ will collect clinical samples across the US in collaboration with leading ovarian cancer specialists and hospitals to support clinical validation, along with regulatory and reimbursement activities.

INOVIQ anticipates the optimisation and validation program required to advance EXO-OC to LDT commercialisation will be finalised by early 2028.

Advertisement

Early Cancer Detection

EXO-OC is an exosome-based blood test developed for the early detection of ovarian cancer in asymptomatic women.

It uses INOVIQ’s proprietary EXO-NET technology to isolate exosomes and combines multiple exosomal micro ribonucleic acid (miRNA) biomarkers with cancer antigen 125 in an AI/machine learning algorithm.

A retrospective case control study of EXO-OC has previously demonstrated 100% stage I/II and 77% all-stage sensitivity at 99.6% specificity.

An updated algorithm achieved 92.3% stage I/II and 92.5% all-stage sensitivity at 98% specificity, supporting its initial intended use in women at elevated risk of ovarian cancer.

Successful validation of EXO-OC would represent a significant step toward making the test available in the US, where the American Cancer Society has estimated approximately 21,010 new ovarian cancer diagnoses and 12,450 deaths nationwide in 2026.

Advertisement

Commercialisation Pathway

INOVIQ chief commercial officer Dr Emma Ball said the Sonic agreement was a significant milestone for the EXO-OC ovarian cancer early detection program.

“By partnering with a leading US pathology provider, we have established a clear pathway to advance EXO-OC towards commercialisation as a LDT in that region,” she said.

“Early detection of ovarian cancer remains a critical unmet need and we are committed to making EXO-OC available to women who may benefit from earlier diagnosis and intervention.”

“This partnership strengthens our US commercialisation strategy and provides a scalable pathway to patient access, revenue generation, and long-term shareholder value.”

Subscribe · daily wire

Get the wire before the market opens.

The ASX small-cap stories that matter, filed before 9am AEST. Curated by the Small Caps desk.

Join 100,000+ investors. Unsubscribe anytime.Filed underBiotechnologyASX:IIQShareAbout the author

Imelda Cotton

JournalistView all articles

More like this

View all latest