Computerized Tomography (CT) scanning is the gold standard in the US for lung cancer screening

  • US guidelines recommend annual low-dose CT scanning to screen high-risk1 patients for lung cancer
  • CT screening has demonstrated a 20% mortality benefit through earlier detection of lung cancer

70% of lung cancers occur in patients who are not eligible for screening under US guidelines2

  • EarlyCDT-Lung can also be used to assess the risk of lung cancer in patients at increased risk3 but who are not eligible for CT screening, but this use may not be covered by payors in the US
  • EarlyCDT-Lung is not a ‘rule-out’ test

The accuracy and positive predictive value of EarlyCDT-Lung make it a useful ‘rule-in’ test in the physician’s kit for assessing lung cancer risk of patients who are at increased risk3 in territories where CT screening is not available

Oncimmune does not promote the use of EarlyCDT-Lung in the US for patients who are ineligible or unwilling to undergo CT screening in the US

EarlyCDT-Lung is being trialled by the NHS in the United Kingdom to improve detection of early stage lung cancer in asymptomatic patients at high risk patients of lung cancer. Read more here

Early stage diagnosis of lung cancer can offer the best chance of survival4

1 55-80 years old, 30 cigarette pack years or more, current smoker or quit less than 15 years ago. See USPSTF
2 Pinsky P. & Berg C., Applying the National Lung Screening Trial eligibility criteria to the US population: what percent of the population and of incident lung cancers would be covered. J Med Screen 2012; 19:154-156
3 Increased risk patients suited to EarlyCDT-Lung are 50+ years old and have 20+ pack years smoking history; the test is also suitable for patients aged 40+, with 20+ pack years who have an additional risk factor. It is not suitable for patients with a history of any cancer other than basal cell carcinoma
Howlader N, et al. SEER Cancer Statistics Review, 1975-2014, National Cancer Institute. Bethesda, MD, https://seer.cancer.gov/csr/1975_2014/, based on November 2016 SEER data submission, posted to the SEER web site, April 2017

a) Positive Predictive Value – the number of positive test results required to detect a cancer.
b) Boyle P, Chapman CJ, Holdenrieder S, et al. Clinical validation of an autoantibody test for lung cancer. Ann Oncol 2011;22(2):383-389.
Chapman CJ, Healey GF, Murray A, et al. EarlyCDT®-Lung test: improved clinical utility through additional autoantibody assays. Tumor Biol 2012;33(5):1319-26.
Healey GF, Lam S, Boyle P, et al. Signal stratification of autoantibody levels in serum samples and its application to the early detection of lung cancer. J Thorac Dis 2013;5(5): 618-625.
c) The National Lung Screening Trial Research Team. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med 2011;365:395-409.
Aberle, DR, DeMello S, Berg CD, et al. Results of the Two Incidence Screenings in the National Lung Screening Trial. N Engl J Med 2013;369:920-931.
d) National Cancer Institute. Breast Cancer Surveillance Consortium: Evaluating Screening Performance in Practice. NIH Publication No. 04-5490. Bethesda, MD: National Cancer Institute, National Institutes of Health, U.S. Department of Health and Human Services, April 2004.
e) Imperiale TF, Ransohoff DF, Itzkowitz SH et al., N Engl J Med 2014; 370(14):1287-1297.
f) Assumed cancer rate (NB: EarlyCDT-Lung has an additional 50% for look-forward (equivalent to 1.8%))



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