OncoCyte Product Pipeline

OncoCyte Corporation is focused on developing diagnostics to address the unmet needs in the detection and screening of lung, breast and bladder cancers.

 

OncoCyte Product Pipeline

Current imaging diagnostic procedures in screening lung, breast and bladder cancer are not meeting the needs of health care providers, patients or payers in that they often produce indeterminate diagnoses due to the high level of false positives.

These indeterminate diagnoses can result in:

  • Physician uncertainty on whether downstream procedures are needed
  • Patient angst and concern about whether or not they have cancer
  • Unnecessary downstream procedures adding incremental costs to health care spend (e.g., bronchoscopies, cystoscopies, biopsies).

As molecular diagnostics evolve from tissue based to liquid biopsy based, fewer downstream procedures will be required resulting in cost savings, earlier diagnosis and decreased risks to the patient.

OncoCyte is developing proprietary non-invasive tests using liquid biopsies (blood and urine) to help physicians improve the screening protocols for lung, breast and bladder cancer patients. OncoCyte’s portfolio of pipeline products detect biomarkers that are associated with specific types of cancer (lung, breast and bladder) to help physicians by confirming false positives to improve the standard of care and reduce overall health care spend.

Lung Cancer Assay (DetermaVu Lung)

  • 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

lung-images

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

OncoCyte’s Non-Invasive, Liquid Biopsy Diagnostic Assay

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.

screening-graphic

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.

Breast Cancer Diagnostic Assay

Current diagnosis protocols for breast cancer screening are not meeting the needs of many patients, including those women with: dense breast tissue, BRCA1 or BRCA2 mutations or a family history of breast cancer. Mammograms have not been an effective screening procedure for these women.

This has resulted in ACS guidelines being written that recommend the use of MRIs for women with a high risk of breast cancer including those with a known BRCA mutation or an immediate family member with a known BRCA mutation. Additionally, they recommend that women with dense breast tissue or a personal history of breast cancer, ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), or abnormal breast cell changes such as atypical ductal hyperplasia or atypical lobular hyperplasia should talk to their physicians about whether they should have MRIs in addition to mammography.

breast-cancer-graphic

The use of mammograms in detecting breast cancer has been shown to produce many false positives resulting in additional costly procedures being done.

  •  ~10% of women are recalled from screening mammography for further testing
  •  ~95% of these recalls are false positives
  •  ~50% of women screened annually over a 10-year period experience false positives
  •  7 to 17% of these women will have biopsies

The use of digital imaging for screening of specific patient profiles is not meeting the needs of practitioners, patients or payers. Rather digital imaging, when used for these women, is producing:

  •  Inconclusive diagnoses
  •  Anxiety for patients
  •  Diagnosis uncertainty for physicians.

OncoCyte’s pipeline breast product is being developed to reduce the number of patients with indeterminate mammograms being sent for biopsies. Each year approximately 350k women have suspicious mammograms (BIRADS 3 and 4) requiring additional procedures to confirm the diagnosis. The company’s test is intended to be used in lieu of biopsy for these women and will be designed to deliver a benign result with a high degree of accuracy.

Sources:

Rosenberg RD et al. Radiology 2006
Elmore JG et al. New England Journal of Medicine 1998
Hubbard RA et al. Annuals of InternalMeducine 2011
Rosenberg RD et al. Radiology 1998
Kerlikowske K et al. Journal of American Medical Association 1996
Porter PL et al. J Natl Cancer Institute 1999

Bladder Cancer Diagnostic Assay

Bladder cancer has been projected to have the highest lifetime treatment costs per patient of all cancers. Bladder Cancer in the U.S. was estimated to cost $125B in 2010, growing to $155B in 2014. The high recurrence rate and ongoing invasive monitoring requirements drive the financial burden of this disease. Estimates of recurrence of early stage bladder cancer are in the range of 10 to 15% of patients in the first year growing to over half of bladder cancer patients. The current standard of care is cystoscopies with biopsies.

bladder-graphic-orange

Estimates of the range of false positives based on cystoscopies can range up to 30% driving health care costs up and resulting in patients having to do unnecessary, painful procedures.

OncoCyte is currently developing a diagnostic that could be more effectively used for:

  • Screening for bladder cancer in patients presenting with hematuria
  • Confirming indeterminate cytology findings
  • Diagnosing recurrence of bladder cancer in patients in remission

OncoCyte presented interim clinical study data for the non-invasive detection of bladder cancer at the American Association for Cancer Research (AACR) in April of 2015 demonstrating a high of sensitivity and specificity in the detection of urothelial carcinoma, the most common type of bladder cancer.

Preliminary findings at AACR showed strong performance with a ROC of over 0.9.

image004
image006