Oncimmune’s (ONC ) Early CDT® lung blood test will be adopted by the Thoracic Surgery Unit of the University Hospital Miguel Servet in Spain for its use on solitary pulmonary nodules.

Today’s approval follows the issuing of a favourable assessment and report by the Evaluation Committee of the Aragonese Health System that the Early CDT®, a test used for the first detection of lung disease, had met the necessary criteria with regards to efficacy and safety.

EarlyCDT is a simple blood test that detects the elevated presence of autoantibodies generated by the body’s immune system as a natural defence against cancer cells.

Oncimmune considers the Aragon Public Health Service’s assessment and subsequent approval ‘an important development’ for the group and for its Spanish distributor, Sabartech, towards the adoption of the blood test by other regional public health systems in Spain.

Today’s approval in Spain follows news announced in November 2021 that EarlyCDT Lung had been authorised for use within the Spanish Public Health Service by the Galician Health Service (SERGAS), the first public health service in Spain to use the EarlyCDT Lung test.

Commenting on this morning’s news, Dr Adam M Hill, CEO of Oncimmune said: “We are pleased with the progress being made by our Spanish distributor, Sabartech, towards the wider adoption of the EarlyCDT blood test within the Spanish public health system.”

The progress being made in Spain is mirroring the positive engagement we are experiencing with several NHS Clinical Commissioning Groups and Cancer Alliances in the UK.”

Hill added that the assessment and approval was “an encouraging development for the continued adoption of the EarlyCDT Lung blood test with national health systems globally.”

Oncimmune’s immunodiagnostic technology, EarlyCDT, was developed to detect and help identify cancer on average four years earlier than standard clinical diagnosis. Its lead diagnostic test, EarlyCDT Lung, targets a vast market estimated to grow to £3.8bn by 2024. 

With over 200,000 tests already performed for patients worldwide and its use being supported by peer reviewed data in over 12,000 patients, the company believes that it is poised to become ‘an integral component of future lung cancer detection programmes, globally.’

The company tells investors that EarlyCDT Lung is ‘the world’s most thoroughly validated blood test for the detection of lung cancer and requires only a small volume of blood which can be taken using a test in the home or community setting as well as a doctor’s surgery.’

The test has been proven to detect lung cancer on average four years earlier compared to current standard clinical diagnosis, while the EarlyCDT lung blood test can also provide an effective assessment of cancer risk in indeterminate pulmonary nodules (IPNs), it added.

In the year to 31 May 2021, Oncimmune said it had experienced a substantial increase in demand for the EarlyCDT Lung from its US partner, Biodesix, which it said was ‘quickly recovering from the lack of demand early in the reporting period as a result of COVID-19.’ 

Given this increase in demand, Biodesix announced that they are planning to expand its national sales team from 32 to 76 by the end of 2022, the group outlined in its final results. 

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