We believe there are many people
who would benefit from a diagnostic test such as DetermaVuTM. The U.S. Preventive Services Task Force recommended in
2013 that individuals aged 55 to 80 years who have a 30 pack-year smoking history and currently smoke or have quit within the
previous 15 years should be screened annually for lung cancer. We estimate that there are about 7 million such individuals in
the United States. In addition, approximately 5 million people undergo incidental scans outside of screening each
year. Given the prevalence and gravity of lung cancer, we believe a noninvasive aid to support patient care and diagnostic
treatment decisions would attract meaningful market interest.
plan to develop any initial tests with a focus on the U.S. market as a category of diagnostics called “laboratory-developed
tests” and plan to market any tests we develop under that regulatory framework. As this area of law and regulation is evolving,
we may have to adjust our future development and marketing plans and may need to pursue U.S. Food and Drug Administration premarket
review and clearance or approval of our tests.
On January 29, 2019, we announced
positive results from our key R&D Validation study, demonstrating the accuracy of DetermaVu™, our confirmatory liquid
biopsy test for lung nodules suspicious for cancer that is intended to provide clinicians and doctors with information
that can aid in patient care and diagnosis.
R&D Validation study demonstrated a sensitivity of 90% (95% CI 82%-95%) and specificity of 75% (95% CI 68%-81%) of DetermaVu™
on a prospectively collected cohort of 250 patient blood samples that were blinded to laboratory operators. Sensitivity is the
percentage of malignant nodules that are correctly identified and specificity is the percentage of benign nodules correctly identified
(with correct identification in our study confirmed by biopsy results or serial imaging). A 95% confidence interval
(CI) suggests that there is a 95% chance that final test performance will be within the stated range.
We believe the results show
that DetermaVuTM exceeds the needs of clinicians and payers because its high specificity could help better inform
clinical decisions, which could help avoid unnecessary invasive biopsies, related complications and their costs. Based
on the results of the R&D Validation study, we believe that DetermaVuTM can become a best-in-class
lung cancer confirmatory liquid biopsy diagnostic test to help aid in clinical decision-making about lung nodules identified
through screening imaging protocols. We plan to make DetermaVuTM commercially available through our clinical laboratory
in the second half of 2019, with the goal of helping fundamentally change the way lung cancer is diagnosed.
Notably, we obtained these
results without including any clinical factors in the OncoCyte-designed DetermaVu™ algorithm, underscoring what we believe
is the biological strength of this laboratory-developed test. DetermaVu™ measures biomarkers of the immune system’s
response to cancer to differentiate between suspicious and likely benign lung nodules in early stage lung cancer. Specifically,
DetermaVu™ has been designed for use in patients with lung nodules ranging from 5-30mm in size detected initially in a computerized
tomography (CT) scan or incidentally through other imaging. Because clinical data points, such as lung nodule size, provide a
significant amount of the diagnostic power for liquid biopsy lung cancer tests developed by other companies, we believe the superior
accuracy range we have seen, to date, for DetermaVu™ independent of any clinical factors reinforces its strength as a confirmatory
diagnostic tool for aiding early lung cancer detection, and provides physicians with significant biologic information
that has not been available prior to DetermaVu™.
We believe DetermaVu™
has the potential to significantly reduce U.S. healthcare costs each year by eliminating unnecessary invasive biopsies,
which, according to an analysis of Medicare data, cost on average $14,634 each. In addition, DetermaVu™ may improve health
outcomes by providing information that may help avoid invasive biopsies and the complications that arise in up to 24% of
such procedures, and deaths that occur in a small number of cases.
In clinical practice, physicians
could use a DetermaVu™ blood test to help determine whether or not a patient’s lung nodule in the 5-30mm range
should be biopsied for cancer. If the DetermaVu™ test indicates a likely benign result, we believe clinicians or
doctors could choose to monitor the patient through serial imaging (follow-up low-dose computed tomography) rather
than ordering a biopsy. With 75% specificity (the percentage of benign nodules correctly identified in the R&D validation
study), we anticipate that physicians could use DetermaVu™ to help prevent up to three quarters of unnecessary invasive
biopsies and their associated complications and, in rare instances, deaths. Currently, for many patients, a
lung biopsy has a higher likelihood of leading to a serious complication than of confirming lung cancer. These anticipated reduced
costs and potential for improved patient outcomes highlight DetermaVu™’s value proposition for payers such as Medicare
and health insurance companies.
The R&D Validation study
utilized the optimized biomarkers and algorithm that were previously identified in our recently completed algorithm development
study, based on 700 patient samples. The R&D Validation study used a blinded set of 250 samples, including samples
from 44 clinical sites, to validate the classifier performance.