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Sample Pathology Reports

SMA Laboratory – Molecular Diagnostics

SMA Labs has been working with our sub-specialized physician base that includes a focus on urology, gastroenterology, dermatology, breast surgeons, and oncologists. Traditionally these diagnostic paradigms are qualitative in nature. In order to provide more quantitative and prognostic evidence to our physicians SMA Laboratory has expanded with a number of cutting edge molecular assays in order to provide our physicians with as much evidence and analysis as possible in order to tailor the treatment regimens of their patients and ultimately provide for better patient outcomes.

From an industry standpoint this was first realized over a decade ago in Breast Cancer with the availability of Herceptin was linked to the overexpression of the Her2/neu marker, initially through quantitative immunohistochemistry and the eventually fluorescent in-situ hybridization (FISH). Current use also includes quantitative ER, PR and Ki-67 via IHC.

Within the urologic field, FISH was introduced for bladder cancer in order to enhance the sensitivity of traditional urine cytology. The early identification of patients who are likely to recur has been well received within the urologic community and is now a standard of care.

This testing has now been expanded in SMA Labs to include PTEN FISH for prostate cancer. PTEN is a tumor suppressor gene that is important in the biologic pathways of prostatic adenocarcinoma. The test can be used on patients with an initial diagnosis of HGPIN to identify those who are at high risk for disease progression. For patients diagnosed with prostate adenocarcinoma a PTEN positive outcome is a poor prognostic indicator and provides the urologist with evidence that a more aggressive treatment option should be considered while a PTEN negative test is a good prognostic indicator and the urologist may pursue a less aggressive treatment regimen. SMA Labs is proud to be one of the few labs with PTEN FISH availability. Further, we are continuing to investigate further enhancements through the ERG-1 markers, both via FISH and chromogenic in-situ hybridization (CISH) and look to have these assays available in the latter part of 2012 to supplement our current testing.

For our gastroenterologists SMA Labs offers micro-satellite instability (MSI) and KRAS and BRAF analysis by polymerase chain recombination (PCR). KRAS mutation testing can help predict treatment response of patients identified with a colorectal cancer. Patients who have a KRAS mutation have a high predictive outcome of not responding to cetuximab and panitumumab. Knowledge of the predictive pathways has allowed for more cost effective treatment options in these patients and overall better outcomes through less trial and error. Additional markers that are being investigated include novel FISH assays for more definitive identification of Barrett's metaplasia and colon FISH testing for the differentiation between tubular adenomas and adenocarcinoma, and prognostic indicators for patients with polyps and tubular adenomas with otherwise high risk factors.

Within dermatology, BRAF testing is now a pharmacogenomics predictor for ZELBORAF treatment. This personalized, targeted therapy is can be used to treat patients who are positive for metastatic melanoma and ensures better outcomes for these patients by targeting those most likely to respond.

SMA Labs is committed to offering the most novel molecular testing for better predictive outcomes and patient focused treatment algorithms, and will continue to work with our physicians on providing them as much diagnostic and prognostic evidence as possible in order to base their treatment decisions.