Clinical Data

BioFluidica's process and diagnostic instruments have demonstrated clinical relevance in many solid cancer types including pancreatic, prostate, melanoma, colorectal, ovarian, myeloma, breast cancer and leukemic cancers such as acute myeloid leukemia.

Clinically Proven
BioFluidica in conjunction with partners at the University of North Carolina School of Medicine and with support from ROCHE, has collected pilot clinical data in a number of cancers using the established EpCAM CTC selection biomarker, a new selection biomarker, and its patented technology for detecting rare Circulating Tumor Cells. Clinical data results generated using Biofluidica's proprietary platform are unprecedented in the marketplace, see Fig. 1. below. In addition, our dual selection process has been found to provide high clinical yields of CTCs that are nearly 100-fold higher than those of the CellSearch® system, and with improved clinical sensitivity and specificity. For example, in the case of metastatic pancreatic cancer, the BioFluidica’s technology captures about 51 EpCAM CTCs per mL of whole blood, while for the CellSearch system, the clinical yield is on the order of 1 CTC per 7.5 mL of whole blood.

  BioFluidica CellSearch
Pancreatic Cancer
Non Metastatic
100% NA
Pancreatic Cancer
Metastatic
100% 19%
Colorectal Cancer
Metastatic
100% 30%
Ovarian Cancer
Metastatic
100% 38%
Breast Cancer
Metastatic
80% 50%

Fig. 1. Clinical comparison performed with support from ROCHE.

Clinical applications and needs where our technology has been demonstrated to provide clinical relevance and can be applied for better diagnostic, leading to better treatment options.

Solid Tumors
Statistics from the American Cancer Society

Pancreatic Cancer
About 48,960 people, 24,840 men and 24,120 women, will be diagnosed with pancreatic cancer.
About 40,560 people, 20,710 men and 19,850 women, will die of pancreatic cancer.
Pancreatic cancer accounts for about 3% of all cancer cases in the U.S., and accounts for about 7% of all deaths.

Along with collaborators, we have demonstrated that our technology can provide 100% clinical specificity and sensitivity for the detection of both metastatic and non-metastatic pancreatic cancer. In addition, using our dual selection strategy, we can use CTCs from both EpCAM and seprase to monitor response to therapy that can serve as a valuable companion diagnostic to discover new therapeutics for this disease.

Ovarian Cancer
About 21,290 women will receive a new diagnosis of ovarian cancer.
About 14,180 women will die from ovarian cancer.
Ovarian cancer ranks fifth in cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system. A woman's risk of getting ovarian cancer during her lifetime is about 1 in 75. Her lifetime chance of dying from ovarian cancer is about 1 in 100. These statistics do not count low malignant potential ovarian tumors.

Using BioFluidica's technology and the dual selection strategy, researchers at the University of North Carolina have shown that both metastatic and non-metastatic ovarian cancer can be detected. Pre-clinical work is underway to understand the potential of the BioFluidica platform as a screening tool to detect ovarian cancer in high risk patients

Breast Cancer
About 231,840 new cases of invasive breast cancer will be diagnosed in women.
About 60,290 new cases of carcinoma in situ, CIS, will be diagnosed, CIS is non-invasive and is the earliest form of breast cancer.
About 40,290 women will die from breast cancer.
Breast cancer is the second leading cause of cancer death in women, exceeded only by lung cancer.

BioFluidica along with its collaborators at the University of North Carolina have collected data on metastatic breast cancer patients and using the patented dual selection strategy, CTCs can be detected in triple negative breast cancer patients, which typically cannot be detected using the FDA-approved test.

Lung Cancer
About 221,200 new cases of lung cancer, 115,610 in men and 105,590 in women.
An estimated 158,040 deaths from lung cancer, 86,380 in men and 71,660 among women.
Lung cancer accounts for about 27% of all cancer deaths and is by far the leading cause of cancer death among both men and women. Each year, more people die of lung cancer than of colon, breast, and prostate cancers combined.

BioFluidica will also apply its technology to this important type of cancer.

Cancers of the Blood

Multiple Myeloma
About 26,850 new cases will be diagnosed, 14,090 in men and 12,760 in women.
About 11,240 deaths are expected to occur, 6,240 in men and 5,000 in women.

BioFluidica along with its collaborators at the University of North Carolina have collected clinical data that the three stages of myeloma can be detected using a simple blood test along with the CD138 selection marker.

Acute Myeloid Leukemia
About 54,270 new cases of leukemia, all kinds, and 24,450 deaths from leukemia, all kinds
About 20,830 new cases of acute myeloid leukemia, AML. Most will be in adults.
About 10,460 deaths from AML. Almost all will be in adults.

Results secured from a pilot clinical data carried out at the University of North Carolina has shown that early stages of relapse can be detected using the BioFluidica technology platform and peripheral blood samples negating the need for a bone marrow biopsy and multi-parameter flow cytometry.

Clinical Data