London, 28 June 2019, Oncimmune Holdings plc (AIM: ONC.L), – a leading global immunodiagnostics group, today announces it has entered into an exclusive partnership agreement which it believes will unlock the full potential of EarlyCDT® Lung in the United States, bringing this lung cancer test to more patients as a result. This agreement with Biodesix, Inc., a leading lung cancer diagnostic solutions company, encompasses both the commercialization by Biodesix of EarlyCDT Lung, as well as the supply by Oncimmune of the EarlyCDT Lung product. The agreement also involves the sale of Oncimmune’s US subsidiary’s operations including the CLIA laboratory. Over the next five years this agreement represents value to Oncimmune of up to $28 million.
The agreement will accelerate the organic growth of EarlyCDT Lung, Oncimmune’s lead product, in the largest lung cancer market in the world. In 2019, it is estimated that there will be 228,150 new cases of lung and bronchus cancer in the US alone . Late stage detection of lung cancer has a 5-year survival rate of five percent, which increases to approximately 57 percent if the tumor is found early while still localized . EarlyCDT Lung helps clinicians assess malignancy risk in patients presenting with indeterminate pulmonary nodules (IPNs) with the aim of improving patient outcomes through earlier intervention.
In addition to use in lung nodules, Oncimmune has also granted Biodesix the opportunity to further capitalize on the commercial potential for EarlyCDT Lung as a screening indication in the US. Following Oncimmune’s announcement on 4 June 2019 that the Early Cancer Detection Test—Lung Cancer Scotland Study (ECLS) had met its primary end-point, it is Oncimmune’s belief that the potential screening indication opportunity increases substantially the total market for EarlyCDT Lung in the US and beyond.
Oncimmune will also collaborate with Biodesix on research and development activities in order to fully leverage EarlyCDT Lung both in the US and other major lung cancer markets.
“In October 2018, I undertook to establish a strategic commercial partnership that fully realises the value of EarlyCDT Lung in the US, not only delivering revenue growth but ultimately helping improve patient outcomes through earlier diagnosis and intervention," Dr. Adam M Hill, CEO of Oncimmune commented. "I believe in Biodesix we have found an excellent partner. Like us, Biodesix is committed to delivering solutions that span the continuum of care, but importantly, focuses exclusively on lung cancer. This agreement is designed to accelerate access for EarlyCDT Lung into the US market and creates a compelling new commercial partnership in lung cancer management.
“We are proud to be working with Biodesix, a company with a successful track record of commercializing three clinical diagnostic lung tests in the US.”
“By integrating both genomic and proteomic technologies, Biodesix is focused on enabling clinicians involved in nodule management and those treating lung cancer to improve patient management and patient outcomes while reducing unnecessary procedures and related side effects, while reducing costs," David Brunel, CEO of Biodesix said. This partnership with Oncimmune, a global leader in autoantibody science, further strengthens our position as the leading lung cancer diagnostic solutions company in the US and initiates a collaboration to fully exploit the potential of EarlyCDT Lung in the US. The addition of EarlyCDT Lung to our portfolio completes our comprehensive solution for all patients with indeterminate lung nodules.”
 https://seer.cancer.gov/statfacts/html/lungb.html Accessed 28 June 2019