BioLuminate, the Silicon Valley start-up that has been working with the Lab since earlier this year to develop a breast cancer detection tool, will begin testing the new diagnostic tool on human volunteer patients at the UC Davis Medical Center next week.
Dubbed the “Smart Probe,” the tool provides earlier, more accurate breast cancer detection that removes no tissue and is expected to achieve accuracy levels comparable to surgical biopsies in detecting cancerous cells.
The first series of testing on human volunteer patients will be on more than 200 women who already are scheduled for a surgical biopsy. With the patients’ consent, the doctor will first insert the “Smart Probe” into the suspicious lesion in the breast and then compare the data gathered from the “Smart Probe” to the pathology report obtained from the biopsy.
“With the knowledge learned in this study, we will be able to develop the first ‘commercial’ prototype,” said BioLuminate President and CEO Richard Hular. “That prototype will be used in our next clinical study that will involve nearly 10,000 women. The data we acquire, each time the needle is inserted into a suspicious lesion and confirmed to be cancerous by pathology, enables us to teach the computer to become more accurate and recognize cancerous tissue on its own.”
The BioLuminate “Smart Probe,” smaller than the needle used in routine blood tests, is inserted into breast tissue after an initial screening indicates an area of concern. The probe looks for multiple known indicators of breast cancer, instantaneously providing physicians with information they can use to determine whether more invasive and costly tests are necessary. Unlike a standard biopsy, the results of the “Smart Probe” procedure are immediately available to patients.
Last year, BioLuminate obtained a license to develop, produce and market the early breast cancer detection tool based on technology originally developed by NASA researchers.
The Lab took the NASA technology and developed it further by miniaturizing and making it applicable to be used on patients. BioLuminate hopes to be able to produce a real-time-measurement instrument that will reduce the need for unnecessary surgery.
“It’s a tremendous accomplishment to see this key technology finally being tested on patients,” said John Marion, the Laboratory’s principle investigator for the Smart Probe. “With BioLuminate, we have taken the multi-sensor NASA concept, selected new optical sensor technology and packaged it into a thin needle-sized instrument that can pinpoint whether a tumor in the breast is cancerous or benign.”
Sensors on the tip of the probe measure optical, electrical and chemical properties that are known to differ between healthy and cancerous tissues. The “Smart Probe’s” sensors begin gathering information the moment the needle is inserted into tissue. Computer software will eventually compare the real-time measurements to a set of known, archived parameters that indicate the presence or absence of cancer. The results can then be displayed instantly on a computer screen.
“The BioLuminate Needle offers the potential to improve localization of cancer tissue, eliminate removal of tissue and the associated complications, and most important, get more accurate information for diagnosis,” said Lydia Howell, director of Cytology at the UC Davis Medical Center and professor of pathology. “The information obtained by the needle also has the potential to be useful in predicting how a cancer may behave. The needle may be able to not only distinguish benign lumps from cancerous lumps, but may also be able to distinguish which cancers are more aggressive so that the patient can receive stronger therapies.”
On Monday and Tuesday, BioLuminate’s “Smart Probe” will be showcased at the “Medtech Insight” ‘IN3 East Fall 2001 conference in New York City. At approximately the same time, human testing will begin at Davis. UCSF is expected to begin its study later this year.