LUNG CANCER CONFIRMATORY DIAGNOSTIC

  • Lung cancer is the leading cancer killer of both men and women in the United States (US) and the leading cause of cancer deaths worldwide1
  • Five-year survival rates are also the lowest of all cancer types (≤18%) due to the majority of diagnoses occurring in late-stage disease (57% in Stages III/IV) 2
  • 7–10 Million Americans are eligible for annual LDCT lung cancer screening resulting in a significant number of suspicious nodules detected 3
  • The current standard of care for confirmatory diagnosis of suspicious nodules is to perform invasive and often risky biopsy procedures 4
  • OncoCyte’s confirmatory diagnostic test provides a non-invasive option to inform clinical decision making and potential avoid downstream invasive procedures

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Background
Despite advances in screening, diagnosis, and treatment of cancer worldwide resulting in a steady increase in survival for most cancers, lung cancer continues to demonstrate poor 5-year survival rates (4%). This is primarily attributed to diagnoses of most lung cancers in late-stage disease, thus limiting treatment options. 2

Early detection of lung cancer is now a national health priority in the United States. The landmark National Lung Cancer Screening Trail (NLST) published in 20115 suggested that low-dose CT (LDCT) screening could result in a 20% mortality reduction with implementation of screening of the high-risk population.  Following these findings in

  • 2013 the US Preventive Services Task Force (USPSTF) clinical practice guidelines were recommended for annual LDCT screening of adults with a ≥30 pack-year smoking history 3;
  • 2014 the American College of Radiology (ACR) validated the effectiveness of applying the Lung Imaging Reporting and Data System (Lung-RADS) to assess the frequency of positive and false-negative findings6
  • 2015 the Centers for Medicare and Medicaid (CMS) announced coverage for patients meeting guidelines screening criteria resulting in access to screening for millions of high-risk patients7.

Current Standard-of-Care 
With 7 to 10 million asymptomatic, high-risk patients now eligible for lung cancer screening, the number of suspicious nodules detected will increase significantly. Additionally, there are approximately 1.57 million Americans with incidental pulmonary nodules identified by CT scans for routine medical care. While nodule size is a strong predictor of lung cancer, it is not always accurate. It is now widely accepted that LDCT procedures produce a high false-positive rate. Certain US geographies have a high prevalence of fungal infections, such as histoplasmosis, which can present large, indeterminate nodules during screening8.

The current standard-of-care for confirmatory diagnosis of suspicious nodules is to perform an invasive, often risky and expensive, biopsy. Unlike other types of biopsies, lung biopsies can result in significant complications and, in some cases, mortality. This is especially true in older patients with co-morbidities. For the average patient, a lung biopsy has a higher likelihood of leading to a serious complication than of confirming lung cancer. Overall, lung biopsy procedures are associated with the following complications annually9

  • 2,600 to 20,000 Collapsed lung events
  • 5,000 to 26,000 Major complications
  • 600 to 1,300 Deaths

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OncoCyte’s Non-Invasive, Confirmatory Liquid Biopsy
OncoCyte’s is developing a confirmatory, non-invasive liquid biopsy test intended to facilitate clinical decision making in lung cancer diagnosis. The diagnostic is being developed as an intermediate step to confirm the absence of cancer between imaging modalities (LDCTs) detecting suspicious lung nodules and downstream invasive procedures that determine if the nodules are malignant.
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Initial studies show strong predictive ability in distinguishing between benign and malignant nodules

  • Prototype classifier study data (n=103) demonstrated 76% sensitivity and 88% specificity
  • Validation study data (n=610) demonstrated 90% sensitivity and 46–54% specificity. Adding nodule size to biomarkers resulted in 90% sensitivity and 81% specificity

Upon completion of the clinical validation studies currently underway, OncoCyte anticipates the commercial launch of the lung cancer diagnostic in late 2017.

References

  1. Siegel, RL et al. Cancer Statistics, 2017. Ca Cancer J Clin. 2017.
  2. National Cancer Institute SEER Cancer Stat Facts: Lung and Bronchus Cancer. Accessed February 1, 2017.
  3. Moyer, VA. Screening for Lung Cancer: US Preventive Services Task Force Recommendation Statement. Ann Intern Med. 2014;160(5):330-338.
  4. Gould, MD et al. Evaluation of Individuals with Pulmonary Nodules: When is it Lung Cancer? Diagnosis and Management of Lung Cancer, 3rd ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2013;143(5_suppl):e93S-e120S.
  5. National Lung Screening Research Team. Results of Initial Low-Dose Computed Tomographic Screening for Lung Cancer. N Engl J Med. 2013 May 23;368(21):1980-91.
  6. McKee, BJ et al. Performance of ACR Lung-RADS in a Clinical CT Lung Screening Program. J Am Coll Radiol 2015;12:273-276.
  7. Centers for Medicare & Medicaid Services Decision Memo (CAG-00439N). February 5, 2015.
  8. Warren, WA et al. Pulmonary nodule tracking using chest computed tomography in a histoplasmosis endemic area. Clin Imaging. 2015 May-Jun;39(3):417-20.
  9. Gould, MK et al. Recent Trends in the Identification of Incidental Pulmonary Nodules. Am J Respir Crit Care Med. 2015 Nov 15;192(10):1208-14.