Oncimmune Holdings Plc (LON:ONC), a pioneering UK-based biotechnology company which has developed a blood test for the early detection of lung cancer, announced this morning that it has obtained the CE Mark for a kit format of its EarlyCDT®-Lung test. The kit enables the EarlyCDT®-Lung test to be performed using a standard 96-well ELISA plate reader, one of the most widely available standard hospital laboratory instruments anywhere in the world. At the time of Oncimmune’s IPO in May last year, the availability of the test in a kit format was seen as essential for market penetration outside the USA, particularly in Asian countries. We believe regulatory clearances and commercialization of the Lung test under the distribution agreements signed last month in South Korea and Israel, will benefit from this CE Marking of the kit format. The new CE Marked kits are expected to be available for launch within 4 months. Oncimmune continues to track solidly against its operational plans and we believe today’s news underscores the high quality of the company including both its management team and its product/technology platform. With today’s news, our risk-adjusted NPV increases to 170p (from 153p previously).
CE Marking certifies that products are manufactured under strict European standards of quality control. In this case, the product meets the requirements set out in the In Vitro Diagnostics Medical Devices Directive 98/79/EC. This standard is valid across Europe and is recognized widely in many other countries outside the EU.
Zeus Comment: The ability for Oncimmune Holdings Plc to effectively commercially launch a new test in many countries is determined by the availability of tests in a kit format which is compatible with existing instrumentation. This simplifies the running of the test for all users and makes it appropriate for the vast majority of hospital and small decentralised laboratories where the only equipment required is a standard, inexpensive 96-well ELISA plate reader. Receiving the CE Mark for the EarlyCDT®-Lung Kit is a significant achievement for the company which will help to commercialise the company’s EarlyCDT® platform. With a CE Marked Kit, we believe the company is well-placed to expand its network of international distributors.
