This invention is a clinically tested method for the sensitive ex-vivo detection of cancer cells in a body fluid sample using a virus that exclusively infects, and replicates in, malignant cells.
This technology utilizes an attenuated herpes virus modified to express a fluorescent marker easily detectable by microscopy or fluorescence-activated cell sorting (FACS), allowing sensitive detection of selectively infected cancer cells. This method is 50 times more sensitive than current cytological detection methods, detecting one cancer cell in 1 million non-cancerous cells with an accuracy rate of 92%. Over 100 distinct cancer cell types, including circulating tumor cells, can be detected in a mixed population of cancerous and benign cells using this methodology, making it a powerful universal cancer diagnostic independent of cancer cell type.
The technique involves collection of any body fluid sample, using any current standard procedure, and mixing it with a viral vector solution. Following 4-8h incubation, the sample is analyzed for fluorescent cell content by microscopy or FACS. Additionally, the identified cancer cells can be isolated for further molecular or morphological characterization.
A rare cancer cell in a mixture of millions of normal cells is difficult to identify under bright-field microscopy and the process is time-consuming, even for a highly trained pathologist. A single cancerous cell infected with the attenuated herpes virus modified to express a fluorescent marker is easily detectable under fluorescent microscopy.
- Highly sensitive diagnostic allows detection of both early-stage localized tumors and circulating tumor cells shed from localized tumors prior to the onset of metastatic disease;
- Simple sample preparation and reading can be done with standard laboratory equipment and does not require a highly trained pathologist, making this diagnostic efficient and cost effective;
- Universal tumor tropism of the fluorescent oncolytic virus increases the applicability of the diagnostic to multiple distinct patient populations;
- Cancer cells can be isolated for further characterization enabling patient customized cancer treatment based on the patient specific cancer subtype.
- Clinical diagnostic cancer screening
- Clinical prognostic cancer screening for developing and monitoring treatment options
- Research tool to enrich rare cancer cell populations for more in-depth study
- Fully validated in vitro
- Validated in clinical studies utilizing pancreatic juice, bronchial fluid, and abdominal fluid
- Clinical studies approved or planned for utilizing blood, cerebral spinal fluid, urine, and peritoneal fluid
Yuman Fong, MD
Fong SM, et al. (2009) Surgery. 146(3)498-505
- U.S. patent application published: US2009/0311664
- National patents issued in Europe, France, Germany, U.K.