NASA Smart Surgical Probe to Begin Clinical Tests

A revolutionary early breast cancer-detection tool based
on NASA technology will begin human clinical trials next week
after receiving the go-ahead from the Food and Drug
Administration.

Dublin, California-based BioLuminate Inc., the start-up
company licensed by NASA to develop, produce and market the
“Smart Surgical Probe,” is set to begin human testing on
volunteer patients at the University of California (UC)
Medical Center in Davis and at the University of California,
San Francisco (UCSF). The Smart Surgical Probe originally was
developed by Dr. Robert Mah at NASA’s Ames Research Center,
Moffett Field, Calif.

“This device is being developed to make real-time, detailed
interpretations of breast tissue at the tip of the needle,”
said Mah. “The instrument may allow health care providers to
make expert, accurate diagnoses as well as to suggest proper,
individualized treatment, even for patients in remote areas,”
he said. The probe is a small, disposable needle with
multiple sensors. This technology and resulting product may
enable physicians to diagnose tumors without surgery, thereby
dramatically reducing the number of unnecessary breast
biopsies women undergo annually.

Smart Probe’s sensors begin gathering information the moment
the needle is inserted into tissue. Computer software
eventually will compare the real-time measurements to a set
of known, archived parameters that indicate the presence or
absence of cancer, and display the results on a computer
screen.

Over 200 patients who are scheduled for a surgical biopsy
will be invited to volunteer to be tested with the Smart
Probe prior to their medical procedure. Recorded data then
will be used to “teach” the probe to distinguish cancerous
tissue from benign.

“With the knowledge gained from this study, we will be able
to develop the first ‘commercial’ prototype. That prototype
will be used in our next clinical study, which will involve
nearly 10,000 women,” said BioLuminate President and CEO
Richard Hular. “The data we acquire each time the needle is
inserted into a suspicious lesion later confirmed to be
cancerous enables us to teach the computer to become more
accurate and recognize cancerous tissue on its own.”

Every week in the United States, approximately 18,000
surgical breast biopsies are performed on women with
suspicious breast lesions that later are determined to be
benign. By taking the Ames Smart Probe and developing it
further in collaboration with the Lawrence Livermore National
Laboratory, Livermore, Calif., BioLuminate hopes to be able
to produce a real-time-measurement instrument that will
reduce the need for unnecessary surgery. “If we are
successful, the probe will significantly improve women’s
health care, and could potentially reduce annual health care
costs,” said Hular.

“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,” said
John Marion, Lawrence Livermore National Laboratory’s
principle investigator for the Smart Probe.

“The BioLuminate needle offers the potential to improve
localization of cancer tissue, eliminate removal of tissue
and the associated complications, and most importantly get
more accurate information for diagnosis,” said Lydia Howell,
M.D., director of cytology and professor of pathology at UC
Davis. “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 also to distinguish which cancers
are more aggressive so the patient can receive stronger
therapies.”

“This is an exciting technology that has immediate and future
promise to improve the treatment of breast cancer,” said
Laura Esserman, M.D., MBA, director of the Carol Franc Buck
Breast Care Center at the UCSF Comprehensive Cancer Center.
“I also am excited by the possibility that this technology
would help us to evaluate the presence of residual disease at
the time of surgical excision, thereby reducing the need for
additional surgery for women who are being treated using
breast conservation.”

On Oct. 29 and 30, BioLuminate’s Smart Surgical 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 UC Davis Medical Center.

“The commercialization of this NASA technology is an
outstanding example of applying space research technology to
bring health care benefits down to Earth,” noted Phil Herlth,
of the Ames Commercial Technology Office.