Product Objectives

Every week 18,846 open surgical breast biopsies are performed on women in the US, with suspicious breast lesions. Only 2,827 (15%) cancers are found. Consequently, 16,019 women will needlessly undergo this traumatic procedure every week, which costs our health care system over $2.3 billion annually. In addition, estimates indicate that 4,615 breast cancers are missed every week when a physician reviews a mammogram or performs a physical exam, and recommends that a biopsy procedure is unnecessary, when in fact cancer was present.

The difficulty for the physician today, is that the initial screening procedures do not provide any specific information regarding known cancer indicators. A light spot on a mammogram x-ray could be many things in addition to cancer. BioLuminate would like to change that situation by providing six specific measurements of known cancer indicators, so that the physician can make a more informed decision on how to proceed with the patient. This procedure would be utilized only after the initial screening revealed a region of concern. The measurements would be taken simultaneously in real time, through a small 20 to 21 gauge disposable needle that is connected to a computer, as the needle is inserted into the suspicious lesion.

The overall accuracy of this device, to detect the presence or absence of cancer, is enhanced by the combination of the multiple simultaneous tissue characterizing measurements that are performed in real time. This concept is one of the primary claims in the NASA invention. Today, the specificity and sensitivity of core needle biopsies are approximately 85%, and the gold standard surgical biopsy is 98%. The BioLuminate smart needle is expected to exceed the accuracy achieved by the core needle procedure, and approach the high levels realized by surgical biopsies. This claim is based on standard probability analysis techniques. If each individual measurement is independently only 80% accurate, the combination of multiple parameters significantly increases the overall accuracy to the 98% range.

Product Details

To achieve these goals, BioLuminate will develop, produce and market a revolutionary measurement device for early breast cancer detection. It will consist of a disposable needle that will be used for each patient test.

The needle will be utilized only after initial screening steps, by a physical exam or mammogram, indicate the presence of a suspicious lesion. Estimates indicate that seven eights of all suspicious lesions are palpable, so the physician will simply insert the needle into the palpable mass. For non-palpable lesions the needle would be guided by ultrasound or x-ray.

Annually in the U.S., approximately 8 million suspicious lesions are uncovered during the initial screening procedure. Approximately 7 million are palpable. The physician then attempts to select which individuals should proceed to the biopsy procedure. Approximately 1.3 million are selected, and roughly 75% are open surgical biopsies, and 25% are percutaneous. Ironically, only 185,000 cancers are found, revealing that 85% of the biopsies were in fact unnecessary. By utilizing the BioLuminate smart needle to generate additional specific data associated with the suspicious lesion before any biopsies are performed, many of the unnecessary surgeries can be eliminated.

A distinct advantage of this approach is that the results are displayed in real time. The physician and patient do not have to wait for pathology results, which on average take approximately two months from first exam to final diagnosis. Consequently, the intense anxiety that many women experience while waiting for a final determination can be eliminated. If the measurements indicate readings that are indicative of cancer, the physician will have a significant option to start treatment immediately.

Reimbursement statistics reveal that the average cost for breast cancer biopsies, which include appropriate weighting factors for surgical and core needle procedures, average approximately $2,620 per patient. The BioLuminate procedure is estimated to cost $525 per test, which includes a $250 disposable needle. Consequently, the net cost savings achieved by using the BioLuminate needle to eliminate unnecessary surgeries is $2,095 per patient. This computes to an annual savings of $2.335 billion for the US healthcare system. Similar savings would be expected in Europe.

The BioLuminate instrument system is expected to cost less that $ 50,000. It will include a small electronic box about the size of a portable typewriter, containing a computer, optical components, conversion electronics and a graphics display. By saving only 24 patients from unnecessary surgeries, the cost of the- system will be totally offset.

The specific parameters that the "smart needle" is expected to measure include oxygen partial pressure, electrical impedance, temperature, and light scattering and absorption properties including deoxygenated hemoglobin, vascularization, and tissue density. It is important to note that each of these parameters have been tested in humans over the past several years in many well controlled studies that focused on defining the differences between healthy and cancerous tissue. Eight of the studies were dedicated to breast cancer. Commercially available sensors and off the shelf electronics were used in the studies, but never in multiple combinations as the NASA patent defines. The combination of the NASA patent, along with the BioLuminate and Lawrence Livermore National Labs (LLNL) approach to reduce the size of the probe to a small 20 to 21gauge needle makes this technology unique in the industry.

Because of the accuracy benefits gained from the six simultaneous measurements, and the real time nature of the device, we expect to exceed the accuracy levels achieved by the core needle biopsy procedure and approach the high level of accuracy associated with surgical biopsies. Furthermore, if cancer is found, the BioLuminate device can be configured to deliver various therapies such as core needle biopsies; cancer markers; laser heat; cryogenics; drugs, and radioactive seeds. It could also be used to track the progress of various therapies by providing the physician with information regarding the status of tumor recession.

Additional benefits include the elimination of unnecessary scar tissue that results from the surgical biopsy procedures. This scar tissue obscures the diagnostic ability of future mammograms, creating a major handicap for the patient. Also, the breast cancer screening effectiveness of mammograms in women less than 40 years of age is marginal because of the denser breast tissue. The BioLuminate smart needle is expected to operate effectively in women of any age.

Consequently, BioLuminate is proposing a new platform technology that is no more invasive than a small needle stick that is less invasive than a routine blood test, but provides much more significant information in real time. In addition, other future applications of this technology could include prostate, lung, colon, cervical and brain cancers.