Technology

TumorLight™ - Diagnostic Imaging Opportunity

Molecular imaging represents a paradigm shift in the focus of medical imaging from the visualization of anatomy and physiology to the study of metabolic and physiological processes at the cellular level, often in real time.  Molecular imaging is defined as noninvasive visualization of normal or abnormal cellular processes at a molecular or genetic level of function.  The use of bioluminescent imaging (BLI) is evolving rapidly within academia and its potential is quickly taking shape.  With BLI it is possible to diagnosis a disease process before there are symptoms or anatomical features such as tumors. Plus, it is possible to track the progression of disease and evaluate the effectiveness of therapy.  It can also be used as an adjunct to surgery, including laparoscopy.  This is an optical imaging modality utilizing a charge-coupled digital (CCD) camera for acquiring images through tissue.  These cameras are commercially available today.

Our molecular imaging product will be regulated as a drug under FDA’s Center for Drug Evaluation and Research (CDER) Office of Oncology Drug Products (OODP) for approval.  As such, preclinical and clinical development will be required. BioLume is preparing a grant request to the National Cancer Institute Center for Cancer Research (NCI-CCR) for testing and development of our TumorLight proteins. The Development of Clinical Imaging Drugs & Enhancers (DCIDE) program is a program to expedite and facilitate the development of promising investigational imaging enhancers or molecular probes from the laboratory to IND status. Through the DCIDE program, the developer of a promising diagnostic agent or probe will be given access to the pre-clinical development resources of the National Cancer Institute in a manner that is intended to remove the most common barriers between laboratory discoveries and IND status.

Recognizing that imaging plays a major role in cancer detection and treatment, NCI-CCR actively invests in preclinical and clinical research.  This grant would make molecular imaging self-funding and create important decision-support data.  We will confirm TumorLight has serious potential in clinical practice.  At that point, we have the choice of raising the funds necessary for clinical development, or out-licensing to a strategic partner.

Another BLI potential cancer application may be use as an office or home topical screening kit for skin melanoma. Skin melanoma is becoming a major medical concern and currently, there is no immediate, topical test for suspicious skin lesions.  Currently, screening for suspicious lesions is via visual inspection by the patient or doctor, and the diagnosis is determined by excision and biopsy of suspicious skin lesions (see Presentations page).