ONCIMMUNE LEADING EARLY CANCER DETECTION
 
ONCIMMUNE LEADING EARLY CANCER DETECTION

EarlyCDT-Lung: a simple blood test for the early detection of lung cancer

  • Our clinically validated blood test for lung cancer measures a panel of 7 autoantibodies associated with small cell and non-small cell lung cancers at all stages of disease
  • EarlyCDT-Lung can detect lung cancer up to 4 years earlier than other methods1. Test performance has been optimised for ‘rule-in’ use in conjunction with CT scanning
  • EarlyCDT-Lung can be used to assess the malignancy risk of CT-detected pulmonary nodules as a ‘rule-in’ test for lung cancer2,4
  • It can also be used in conjunction with CT scanning to ‘rule-in’ and assess the risk of lung cancer in asymptomatic patients at increased risk of the disease3,4,5. It is not a ‘rule-out’ test.
  • EarlyCDT-Lung can be billed in the US to most major payors. It is currently self-pay elsewhere in the world
  • The test may only be ordered by physicians. It requires a small blood sample either drawn by a phlebotomist or by the patient using a simple finger stick self-draw kit
  • EarlyCDT-Lung test is run in our CLIA-certified laboratory in the US
  • It can also be run in hospital laboratories outside the US using our proprietary CE and ISO 13845:2012 marked kit

1 Zhong L, et al., Profiling Tumour-Associated Antibodies for detection of Non-small Cell Lung Cancer J Thor Oncol 2006; 1:513-519
Jett J, et al., Determination of the detection lead time for autoantibody biomarkers in early stage lung cancer using the UKCTOCS cohort. J Thor Oncol 2017; 12(11):S2170
For patients with one or more nodules the combined test results ‘Moderate Level’ and ‘High Level’ have Accuracy 83% and PPV 59% (1 in 1.7). For a ‘High Level’ test result: Accuracy 84% and PPV 1 in 1.3 (78%). (Based on lung cancer prevalence of 20%)
In asymptomatic patients at increased risk5: Accuracy 92%, PPV 10% (1 in 10);  for combined Moderate and High Level results.  For a High Level test result Accuracy 97% and PPV 1 in 5 (20%). (Based on lung cancer prevalence of 1.2% increased by a conservative 50% to account for the “look forward” ability for autoantibodies to be detected prior to a cancer being detectable by imaging1)
4 Combined Moderate and High Level test result: Specificity 93%; Sensitivity 41%. High Level test result: Specificity 98% and Sensitivity 28%
5 Increased risk is defined as 20+ pack years and 50+ years, or 40+ years and another risk factor

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