Oncimmune obtains CE mark for EarlyCDT-Lung test

Early cancer detection company Oncimmune Holdings announced on Wednesday that it obtained the CE mark for its EarlyCDT-Lung test in an ELISA kit format.

The AIM-traded firm described the EarlyCDT-Lung product as a “simple” autoantibody blood test that could detect lung cancer up to four years earlier than other methods.

It said the CE mark certified that the kit met the “strict” EU standards of manufacturing and quality control dictated by the In Vitro Diagnostics Medical Devices Directive 98/79/EC (IVD Directive).

The company was now ordering its first batch of commercial kits which would be available within four months in time for launch, the board said.

It also explained that the kit had the advantage of running on already well established ELISA-96 well-microplate-instruments that hospitals worldwide had as standard equipment in their laboratories.

“The development and completion of a kit version of the EarlyCDT-Lung test was a key part of the commercial growth strategy laid out at the time of our IPO,” said Oncimmune CEO Geoffrey Hamilton-Fairley.

“This success positions us to make the test available to hospitals around the world for running in their own laboratories.”

Hamilton-Fairley said that, until it was certain that the EarlyCDT-Lung test would successfully transfer to a kit, Oncimmune's commercialisation plans for territories outside of the US were conservative as adoption of the test was likely to be slower if it could only offer a central laboratory test.

“The CE marked kit now allows us to address these markets and support our distributors with a simple test in a well-known, easy to use format.

“We believe this development will greatly help us in accelerating our appointment of global distributors and support their ongoing performance.”