Powerful Universal Cancer Diagnostic Utilizing Fluorescent Oncolytic Viruses

SK1141

Summary of Invention

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.

Background

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.

Advantages

  • 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.

Areas of Application

  • 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

Stage of Development

  • 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

Lead Inventor

Yuman Fong, MD

References

Fong SM, et al. (2009) Surgery. 146(3)498-505

Patent Information

  • U.S. patent application published: US2009/0311664
  • National patents issued in Europe, France, Germany, U.K.

Contact Information

Yashodhara Dash, MBBS, PhD, MBA, CLP
Senior Manager, Technology Management and Commercialization
Tel: 646-888-1073
Stage of Development
Ready to use
Indications