Cleo Diagnostics (ASX:COV) has launched technology transfer activities in support of the group’s commercialisation push for its innovative blood test designed for the early and accurate detection of ovarian cancer.
This development marks the conclusion of a critical milestone for the manufacturing pathway of the product, with Cleo now aiming to bring to market a diagnostic test kit which is compliant with the US Food and Drug Administration (FDA).
Critical step in commercialisation drive
Management noted that this key step involves the transfer of in-house development activities to an FDA-accredited manufacturer, which could open the door for commercial production of its ovarian cancer test.
In turn, Cleo has engaged the services of US-based R&D Systems to assist with this process as it seeks to scale and assemble its proprietary antibodies used in the test.
According to the company, R&D Systems is a leader in immunoassay technology with state-of-the-art production facilities and globally recognised expertise.
Management noted that the collaboration between the duo helps to ensure the successful progression of commercial prototype development, whilst also supporting Cleo’s transition to large-scale manufacturing of the test.
R&D Systems will be responsible for the remaining steps towards pre-production kit assembly and testing.
Path to US commercialisation
Subsequently, the company’s selected FDA-registered Contract Manufacturing Organisation (CMO) will assist in scaling production capability as well as verification and validation activities.
According to the company, this will facilitate the production of GMP and ISO13485 compliant in-vitro diagnostic (IVD) kits for clinical deployment.
In turn, these test kits are expected to support the completion of Cleo’s ongoing clinical trials in the US and Australia, which will then allow the company to submit its 510(k) application to the FDA to demonstrate that its diagnostic test is safe and effective.
Negotiations with CMOs are now nearing the finish line as Cleo weighs up the most suitable option according to manufacturing capability, regulatory compliance, and ability to scale.
Cleo Diagnostics chief executive officer, Dr Richard Allman, commented:
“The commencement of technology transfer marks a pivotal milestone in CLEO’s strategic pathway toward commercialisation. During this phase, we refine and scale our assay technology, to ensure the Company is well positioned to progress its Ovarian Cancer test from prototype production to a commercially available, FDA-compliant diagnostic kit.”
Unmet medical need
Cleo’s strategy is centred on delivering an accurate and accessible cancer diagnostic solution which addresses a critical and global unmet need in the detection of ovarian cancer.
Based on research from The American Cancer Society, nearly 21,000 American women are projected to receive a new diagnosis of ovarian cancer in 2025, with the condition forecast to cause more than 12,000 fatalities by the end of the year.
According to Cleo, only about 20 per cent of ovarian cancers are detected at an early stage of the disease.