Our Scalable MCD Platform Measures 18 Protein-Generated Parameters

Detects 99% of target cancers including breast, lung, ovarian, colorectal and pancreatic cancers. 

Both protein and immune biomarkers are used to define the test resulting in a high degree of early cancer detection (99%).

A low false positive score (1%) indicates reliability and actionable clinical results while eliminating unnecessary downline testing.

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.

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).

Recently, the FDA has proposed new guidelines for MCDs 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).

Current screening for breast cancer via mammograms and for lung cancer using low-density CAT scans (LD-CT) misidentify as many as one in four individuals as having cancer when they do not, in fact, have cancer. 

Following a positive mammogram or LD-CT scan, our platform rules out false positives with 98% accuracy potentially eliminating follow-up testing annually in the U.S. for over 360,000 patients with positive mammograms and 550,000 patients with positive LD-CT Lung cancer scans. 

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. 

Differentiates between serous and mucinous ovarian cancers. 

The most aggressive type of ovarian cancers is found among the serous cancer subtype.