OncoCyte Confirmatory Lung Cancer 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 among 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 procedures4
- OncoCyte’s confirmatory diagnostic test provides a non-invasive option to inform clinical decision making and potential avoid downstream invasive procedures
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%) for those diagnosed in a late-stage of distant or metastatic disease, which is still large percentage of patients. 2
Early detection of lung cancer is now a national health priority in the United States. The landmark National Lung Cancer Screening Trial (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.
- In 2013 the US Preventive Services Task Force (USPSTF) clinical practice guidelines recommended annual LDCT screening of adults with a ≥30 pack-year smoking history 3;
- In 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
- In 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.
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 can have 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
DetermaVu™ is OncoCyte’s confirmatory, non-invasive, liquid biopsy test intended to facilitate clinical decision making in lung cancer diagnosis. DetermaVu(tm) is being developed as a confirmatory test for presence or absence of lung cancer to reduce the need for unnecessary invasive biopsies when suspicious lung nodules are detected by imaging modalities such as x-rays or other scans. OncoCyte estimates that an annual market of up to $4.7 billion could develop in the U.S. for its confirmatory lung cancer liquid biopsy test, depending on market penetration and reimbursable pricing.
DetermaVu™ is a trademark of OncoCyte Corporation.
R&D Validation Study Highlights:
- DetermaVu™ demonstrated sensitivity of 90% (95% CI 82%-95%), and specificity of 75% (95% CI 68%-81%) in a prospectively collected cohort of 250 patient blood samples that were blinded to laboratory operators, and without the use of clinical factors such as nodule size
- Results are the first ever in a blinded prospective study to confirm OncoCyte’s approach of utilizing the immune system’s response to early stage cancer to provide a robust biological signal in blood that supports physicians in differentiating between malignant and benign lung nodules
- These results are consistent with previous studies of DetermaVu™, even though this study achieved statistically equivalent results using biomarkers alone, without the use of clinical factors such as nodule size, further confirming the strength and robustness of the biomarkers in the assay
- The Company’s immune system interrogation approach overcomes significant challenges and limitations associated with early stage lung cancer detection using other liquid biopsy approaches, such as circulating tumor cell and cell free DNA detection, which have failed to demonstrate sensitivity and specificity characteristics comparable to DetermaVu™, particularly in early stage lung cancer patients
Upon completion of Analytical Validation, CLIA Validation, and Clinical Validation, OncoCyte anticipates making DetermaVuTM commercially available in the second half of 2019.
- Siegel, RL et al. Cancer Statistics, 2017. Ca Cancer J Clin. 2017.
- National Cancer Institute SEER Cancer Stat Facts: Lung and Bronchus Cancer. Accessed February 1, 2017.
- Moyer, VA. Screening for Lung Cancer: US Preventive Services Task Force Recommendation Statement. Ann Intern Med. 2014;160(5):330-338.
- 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.
- 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.
- McKee, BJ et al. Performance of ACR Lung-RADS in a Clinical CT Lung Screening Program. J Am Coll Radiol 2015;12:273-276.
- Centers for Medicare & Medicaid Services Decision Memo (CAG-00439N). February 5, 2015.
- 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.
- 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.