Smart Probe to begin testing at UC Davis
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.