Key Discovery: Methods of Pattern Recognition
Our patented method for detecting unique cancer patterns begins with simple proteins. They're more abundant than DNA, easier to measure without expensive amplification and processing, and are formed at the earliest stage of cancer growth. We've discovered unique cancer patterns that are formed by specific Kinase proteins and the immune response. Reported results of early testing (Target Health):
Multi-Cancer Detection (MCD)
Detects 99% of target cancers including breast, lung, ovarian, colorectal and pancreatic cancers.
Stage I Accuracy
Both protein and immune biomarkers are used to define the test resulting in a high degree of early cancer detection (99%).
Low False Positives
A low false positive score (1%) indicates reliability and actionable clinical results while eliminating unnecessary downline testing.
Sensitivity
Correctly reflects the ability to identify true positive cases. A negative result does not conclusively rule out the presence of cancer if the test does not have a high sensitivity.
In cases of clinical uncertainty, many unnecessary, painful and costly biopsies are performed to confirm the presence of cancer.
Definitive Diagnostics' protein-platform is designed for patients and their physicians as a powerful tool for cancer screening.
Specificity
Indicates the capacity to correctly identify true negative cases.
High specificity is essential to prevent false positives, ensuring that individuals without cancer are not misdiagnosed and subjected to invasive and costly diagnostic and intervention procedures, and patient anxiety.
A test with 99% sensitivity and 98% specificity would find 99% of cancers that are present (or 1% false negatives), 2% would be incorrectly identified as cancer (false positive).
Tissue of Origin (TOO)
Recently, the FDA has proposed new guidelines for Multi-Cancer Diagnostic (MCD) tests that would require high TOO for approval. Proper identification of TOO in an MCD is critical. Many multi-cancer tests may indicate that a cancer is present, but not necessarily pinpoint the type of cancer.
Our MCD platform identifies the cancer TOO with 98% certainty providing actionable results to eliminate unnecessary downline testing (and cost).
Implications for Breast & Lung Cancers
Current screening for breast cancer via mammograms and for lung cancer using low-density CAT scans (LD-CT) misidentify patients as having cancer when they do not.
Following a positive mammogram or LD-CT scan, our platform could rule out false positives with 98% accuracy, and potentially eliminate wasteful follow-up testing for millions of patients who undergo additional testing, biopsies, and follow-up examinations.
Subtype Differentiation: Lung Cancer
In lung cancer, the MCD platform successfully differentiated small cell lung cancer (SCLC) from non-small cell lung cancer (NSCLC).
SCLC occurs in about 15% of the lung cancer cases and is highly aggressive. Identifying its presence is critical so that the appropriate therapy can be selected for the particular subtype of lung cancer.
Subtype Differentiation: Ovarian Cancer
Differentiates between serous and mucinous ovarian cancers.
The most aggressive type of ovarian cancers is found among the serous cancer subtype.