INOVIQ signs Sonic Healthcare USA agreement to validate EXO-OC™ ovarian cancer test
INOVIQ Limited (ASX:IIQ) has entered into a Validation and License Option Agreement with Sonic Healthcare USA, Inc. to validate its EXO-OC™ ovarian cancer early detection test. The agreement was announced on 2 November 2026 and may support future US commercialisation.
Under the agreement, INOVIQ has granted Sonic Healthcare USA a licence to transfer, optimise and validate EXO-OC™ at Sonic’s CAP/CLIA-certified laboratory in Rye Brook, New York. The agreement also provides a non-exclusive option to pursue a licence to offer EXO-OC™ as a Laboratory Developed Test (LDT) in the United States.
Key facts from the announcement:
- Sonic Healthcare USA delivers pathology services to 20 million physicians and patients across the US.
- The terms of the agreement are confidential.
- The option is subject to successful validation, exercise of the option and subsequent commercial discussions.
Sonic Healthcare USA’s current role is limited to the transfer activities necessary to optimise and validate the test. It has not committed to a future commercial licence, broader technology transfer or commercial partnership.
INOVIQ describes the agreement as a key step in its US commercialisation strategy for EXO-OC™. The company also describes it as creating a potential route to earlier market entry, patient access and revenue generation.
Dr Emma Ball, Chief Commercial Officer, INOVIQ
“By partnering with a leading US pathology provider, we have established a clear pathway to advance EXO-OC™ towards commercialisation as a Laboratory Developed Test in the United States…”
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EXO-OC™ performance data behind the agreement
How the test works
EXO-OC™ is an exosome-based blood test being developed for the early detection of ovarian cancer in asymptomatic women. Exosomes are tiny particles released by cells, and they carry molecular signals that can reflect what is happening inside the body.
The test uses INOVIQ’s proprietary EXO-NET® technology to isolate exosomes. It then combines multiple exosomal miRNA biomarkers with CA125 in an AI/machine learning algorithm. miRNAs are short genetic molecules that can act as markers of disease.
Early detection matters because, according to INOVIQ, ovarian cancer is often diagnosed at a late stage when survival rates are poor.
Sensitivity results
EXO-OC™ previously demonstrated 100% stage I/II and 77% all-stage sensitivity at 99.6% specificity in a retrospective case-control study. An updated algorithm achieved 92.3% stage I/II and 92.5% all-stage sensitivity at 98% specificity.
| Version | Stage I/II sensitivity | All-stage sensitivity | Specificity |
|---|---|---|---|
| Earlier retrospective case-control study | 100% | 77% | 99.6% |
| Updated algorithm | 92.3% | 92.5% | 98% |
The updated algorithm results were reported from a 498-sample retrospective case-control study (ASX: 2 June 2025). INOVIQ states the updated algorithm supports its initial intended use in women at elevated risk of ovarian cancer.
The enhanced EXO-OC algorithm lifted all-stage sensitivity from 77% to 92.5%, though a larger 1,200-sample study was abandoned after biorepository quality failures unrelated to the test itself.
These results have not yet been independently validated by Sonic Healthcare USA and should not be interpreted as Sonic Healthcare USA’s endorsement of the test’s clinical performance.
Dr Mohamed Salama, Chief Medical Officer, Sonic Healthcare USA
“Sonic Healthcare USA is committed to improving patient care through the responsible evaluation of innovative diagnostic technologies…”
Dr Salama said any potential future clinical implementation or commercial arrangement would be considered only after completion of Sonic’s validation assessment and subsequent commercial discussions.
A large unmet need and a growing market
The announcement cites the following figures on ovarian cancer and the diagnostics market:
- The American Cancer Society estimates approximately 21,010 new US ovarian cancer diagnoses and 12,450 deaths in 2026.
- The Global Cancer Observatory reports approximately 330,000 cases and 207,000 deaths worldwide each year.
- The global ovarian cancer diagnostics market is expected to reach US$3.1 billion by 2035, according to Grand View Research.
INOVIQ’s stated commercial strategy is to first advance EXO-OC™ as an LDT in the United States for women at elevated risk of ovarian cancer. Beyond that initial pathway, INOVIQ intends to further develop EXO-OC™ as an In Vitro Diagnostic (IVD) for broader ovarian cancer screening.
What happens next for EXO-OC™
The announcement sets out the following steps:
- Optimisation and validation program: INOVIQ anticipates the program required to advance EXO-OC™ to LDT commercialisation will take approximately 12-18 months, targeting early CY2028. This timing and any potential commercialisation remain subject to validation outcomes and further commercial discussions.
- US clinical sample collection: INOVIQ intends to collect clinical samples across the United States in collaboration with leading ovarian cancer specialists and hospitals, alongside the validation work. The activity is intended to support clinical validation, regulatory and reimbursement activities, and progress will be influenced by the availability of samples.
- Option decision: Sonic Healthcare USA’s option to pursue a licence depends on successful validation, exercise of the option and subsequent commercial discussions.
For investors, the agreement is a validation milestone rather than a commercial licence. Sonic Healthcare USA has not committed to a future commercial licence, and the terms of the agreement are confidential.
Investors exploring the longer commercialisation timeline can read our detailed coverage of INOVIQ’s US launch roadmap, which sets out the four-stage plan and the independent expert review of the OC2200 data.
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