Preclinical Applications
Oncology drug research typically progresses through a phase in which the effects of a proposed drug are tested in animal models. The animal is bred, raised, afflicted with the disease, subjected to the proposed drug, and evaluated. Each change in conditions – dosage, duration, age, etc – often requires additional animal studies. Drug effects are typically evaluated by using one or more of the following methodologies:
- By hand, such as measuring a tumor with a caliper
- By dissection and microscopic or assay examination
- By imaging modalities such as PET, CT, or fluorescence
Evaluation by hand gives very rough measurements (eg, tumor sizes measured on a millimeter scale). Evaluation by dissection is very labor-intensive, and requires large numbers of animals if every dosage and duration is to be evaluated. Evaluation by the various imaging techniques is very expensive, often requires special animal handling (eg, PET-scanned animals are radioactive), and ultimately gives only images of the tumor, not precise measurements. Millions of animals are used every year in the United States for medical tests. Tests require many measurements per animal, with every measurement taking too much time, costing too much money, and yielding too little data.
We are commercializing a technology that provides noninvasive, real-time measurement of the number of cancer cells in an animal. The technology was developed as part of several NIH-funded research programs, and the NIH has requested that it be made generally available. It allows accurate measurement of tumors before they are even detectable by other methods, reducing the time needed to evaluate drugs.
The animals can be measured almost continuously in normal animal laboratory settings, reducing the number of animals needed and eliminating special handling required for radioactive tests. Measurements cost tens of dollars, rather than hundreds of dollars with other imaging methods. Measurements can be made in minutes by laboratory technicians, as no dissection, no microscopy, and no specialized instrument operators are required. Measurements provide cell counts directly, so there is no need to infer tumor behavior from coarse caliper measurements or image analysis.
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