Cleo Diagnostics has appointed Bio-Techne’s CLIA-certified U.S. laboratory Asuragen to run pivotal clinical validation for its pre-surgical ovarian cancer test. The approximately 1,470-sample program is intended to generate the evidence supporting a planned FDA 510(k) submission in the first half of calendar 2027.
- Asuragen engaged for pivotal U.S. clinical validation
- Approximately 1,470 samples across three studies
- Program will measure sensitivity, specificity, PPV and NPV
- Bio-Techne relationship now spans kits, platform and clinical testing
- FDA 510(k) submission targeted for 1H CY2027
Asuragen appointed for pivotal U.S. validation
Cleo Diagnostics Limited (ASX:COV) has chosen Asuragen, a CLIA-certified U.S. clinical laboratory owned by Bio-Techne Corporation, to conduct the pivotal clinical validation of its pre-surgical ovarian cancer test. The appointment moves Cleo’s program into the evidence-generation phase that will determine how the commercial assay performs in its intended patient population.
The planned program will assess approximately 1,470 samples and generate data on sensitivity, specificity, positive predictive value and negative predictive value. Those results are central to demonstrating whether the test can distinguish benign from malignant ovarian disease, although the announcement contains no clinical performance results yet.
Three studies will assess clinical performance
The largest component is a pivotal clinical performance study involving about 600 samples collected through Cleo’s U.S. pivotal clinical trial across 19 sites. A separate clinical specificity study will use roughly 570 samples from patients with non-ovarian benign or malignant conditions, while a healthy individuals study will include about 300 samples to establish expected value ranges in a non-disease population.
That structure gives the validation program a wider remit than simply testing the assay against ovarian cancer cases. It is designed to examine performance in the intended disease setting, test specificity against other conditions and establish a baseline among healthy individuals.
Bio-Techne relationship expands across development chain
Asuragen’s role extends Cleo’s relationship with Bio-Techne across commercial test-kit manufacturing, the Ella diagnostic platform and pivotal U.S. clinical testing. The appointment follows Cleo’s receipt of its first production batch of test kits, which is undergoing internal verification before formal analytical validation begins.
Cleo says the clinical validation data, combined with analytical performance data, will form the core evidence base for a planned FDA 510(k) submission targeted for the first half of calendar 2027. That timetable remains dependent on the completion and results of both validation streams, followed by regulatory review; the announcement does not provide study completion dates or commercial terms.
Bottom Line?
The next meaningful test is not the appointment itself, but whether the two validation programs produce the performance data needed for the targeted FDA submission in 1H CY2027.
Questions in the middle?
- When will formal analytical and clinical validation begin and finish?
- What sensitivity, specificity, PPV and NPV will the completed studies demonstrate?
- Will the FDA 510(k) submission remain on track for the first half of calendar 2027?