Billing codes have been established for nuclear breast imaging procedures and the uptake agent.

• 78800 Tumor imaging (limited area)
• 78801 Tumor localization (multiple areas)
• A9500 Imaging agent - Technetium TC 99m (Sestimibi).

Average reimbursement rates range from $200 - $700 depending on geographic region and payers' policies for reimbursement.

Lobular carcinoma is very difficult to detect with any imaging modality; however, in Dilon's clinical studies 100% of the biopsied lobular carcinomas were detected and 66% of those were sub-centimeter.

The Dilon 6800 produces a very low number of false positive results. When it does occur, it is mainly due to focal areas of radiopharmaceutical uptake in local inflammation, some fibroadenomas, and occasionally fibrocystic changes. A common pathological feature among false positive findings is atypical ductal hyperplasia and is strongly correlated with the presence of proliferative changes. Researchers speculate that such lesions might reflect a pre-malignant potential.

With a negative predictive value of 99%, doctors and patients can be 99% confident that a negative result is a true negative.

Mammograms remain the gold standard in breast cancer screening and should always be the first step in breast cancer detection. When indicated for use in combination with BSGI, the opportunity to more effectively manage a number of challenging case types is significantly enhanced.

Yes; the relatively low acquisition cost, and lack of need for build-out or special facilities for the Dilon 6800 makes it easy to incorporate into a practice or breast center. The reimbursement for each procedure will assure that the Dilon 6800 is a revenue-generating addition to any practice.

While scintimammography (SN) had shown promise as an adjunct diagnostic to mammography, the limitations of standard gamma cameras prevented it from being as useful as it could be. With the introduction of the Dilon 6800, BSGI is made possible, delivering on the promise of scintimammography by overcoming those limitations and providing superior imaging capability with breast optimized detectors. The evolution of scintimammography to BSGI is similar to that of mammography from 20 years ago until now. Early mammograms were obtained in the rudimentary fashion of using standard chest x-ray machines to capture images, but it was not until the advent and adoption of breast-specific x-ray equipment did the procedure render the medical efficacy required to be a true screening and diagnostic tool.

In one study, sensitivity and specificity of scintimammography were 90% and 93.8% respectively, suggesting that scinitmammography is useful in the early detection of breast cancer and in decreasing the number of unnecessary biopsies (Breast Scintigraphy Today: indications and limitations, April 23, 2004). With the advent of detectors optimized for the breast, the sensitivity and specificity values have improved to 96% and 92% respectively, and BSGI is considered a valuable tool in helping to determine the need for biopsies, six-month follow-ups, and surgical planning

BSGI is an accurate and non-invasive method for the detection of cancers in cases where scarring and fibrosis are present due to previous treatments for cancer; specifically because of its ability to differentiate normal dense scar tissue from cancer. Imaging modalities such as MRI and ultrasound rely on anatomical imaging, often resulting in poor accuracy in a post-treatment breast.

The Dilon 6800 has a FDA 510 (k) authorization.

While the radiation dose to the whole body is approximately equivalent to that from a mammogram, the dose to the breast is lower.

Technetium TC 99m Sestimibi or trade named Miraluma™ (a.k.a. Cardiolite™ Bristol Myers Squibb), the radiopharmaceutical used in the BSGI procedure, has been used safely for over 15 years. For additional information about the pharmaceutical risks of Technetium TC 99m Sestimibi please visit http://www.cardiolite.com/index_flash.html.

Insurance policies and procedures can vary. This procedure is generally covered by Medicare / Medicaid and most private carriers.

While dependent on your population, in general, 10-25% of your patients could fall into one of the following categories:

Clinical Indications for BSGI

• Radiodense breast difficult to image.
• Evaluation of indeterminate or suspicious lesions identified by mammography.
• Post surgical or post therapeutic evaluation of mammographic tissue changes.
• Evaluation of multiple lesions or clusters of microcalcifications to aid in biopsy target selection.
• Palpable mass not demonstrated in mammogram or ultrasound.
• Determining the extent of the primary lesion.
• Detecting multicentric and multifocal disease for treatment planning.
• Evaluating the axillary region for node status in breast cancer patients.

BSGI, a molecular study of the breast, differs from other breast imaging modalities such as mammography, ultrasound and MRI- in that it is a functional test rather than a structural test. Structural or anatomical imaging takes a picture of the structures within a breast that are normal or abnormal, like cysts, glands, ducts, tumors or scar tissue. While these imaging techniques identify the presence of such structures, they cannot necessarily determine what they are. BSGI, as a functional procedure images cellular metabolism; while mammography, MRI and ultrasound image tissue density. Functional imaging allows physicians to see the breast more clearly by helping to differentiate benign from malignant tissue.