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New Test for Cancer Researchers Targets Important Tumor-suppressor Protein

As researchers push to develop more customized diagnostics and therapies for solid tumor cancers, they demand increasingly sensitive tests that offer reliable, reproducible analysis. Spring Bioscience, Inc. (Spring) recently announced a new addition to its specialized portfolio of valuable antibodies for cancer research with the introduction of the Anti-PTEN (SP218) rabbit monoclonal immunohistochemistry (IHC) antibody.

PTEN is a common protein found in most tissues of the body. The protein acts as part of a critical cell signaling pathway that tells cells to stop dividing, helping to prevent uncontrolled cell growth that can lead to the formation of tumors. Mutations in the PTEN gene, together with other factors resulting in loss of PTEN protein, are a step in the development of many human cancers, including prostate and colon cancer. PTEN mutations are also believed to be the cause of a variety of inherited predispositions to cancer.

“With SP218, we’re seeking to set a new gold standard across the industry by offering an extremely sensitive, highly specific antibody optimized for IHC testing that will allow researchers and pathologists to interpret PTEN status with utmost confidence,” says Spring General Manager Michael Rivers. “For our customers, this means we’re continuing to offer unparalleled value through superior tests that lead the market in innovation, reliability and quality.”

Spring internal comparison studies demonstrated that SP218 provides more accurate, sensitive, and specific detection compared to similar research use only (RUO) tests on the market today.

Samples from more than 100 cases of primary prostate and colon cancer showed 100 percent concordance for PTEN loss among Spring’s SP218 and the leading commercially-available PTEN RUO tests; however, competitor tests exhibited some undesirable non-specific staining in IHC testing, while SP218 demonstrated highly specific staining in cells with and without PTEN expression.

“SP218’s robust and consistent performance with IHC analysis is particularly important given PTEN’s potential as a companion diagnostic biomarker,” adds Rivers. “Spring Bioscience is owned by Ventana Medical Systems, Inc., a member of the Roche group, and serves as an Antibody Center of Excellence for Roche’s companion diagnostics development to advance our goal for Personalized Healthcare.”

“Several pharma partners have embraced SP218 as their go-to antibody for PTEN IHC and are including it in their clinical trials as a potential companion diagnostic,” says Doug Ward, VP and Lifecycle Leader, Ventana Companion Diagnostics. “In addition, the Ventana Translational Diagnostics CAP/CLIA Laboratory is now using SP218 as their preferred RUO test for PTEN protein expression.”

Spring is known across the research industry for its quality development practices and for delivering a consistent supply of highly-specific antibodies. SP218 meets the company’s high standards as a valuable tool for assessing PTEN loss.

Source: Spring Bioscience

med fusion and Theranostics Health Release Novel Cancer Theranostic Test

med fusion and Theranostics Health will introduce the first of the TheraLink™Assays for use in patients with malignant diseases at the American Society of Clinical Oncology (ASCO) Annual ’13 Meeting, held in Chicago, IL from May 31, 2013 through June 4, 2013. The TheraLink™ HER Family Assay for primary, recurrent and metastatic breast cancers provides a molecular analysis of each patient’s unique cancer, based upon the functional activity of signal transduction pathways known to modulate cancerous growth. This ‘theranostic’ assay provides a comprehensive molecular profile of the HER family of cell surface receptors and three key signaling pathways modulated by the HER family which have important roles in the therapeutic approach to treating breast cancer. The TheraLink™ HER Family Assay is the first in a series of similar assays based upon measuring a panel of analytes, including a number of drug targets.

med fusion and Theranostics Health will also announce that they are entering into an exclusive distribution agreement for Theranostics Health’s TheraLink™ HER Family Assay. Under the terms of the agreement, med fusion and its affiliate, Pathologists Bio-Medical Laboratories (PBM), will provide a gateway for access to the theranostic test for the McKesson Network of oncologists, which includes US Oncology and Texas Oncology and to the oncologists of the Baylor Healthcare System. Oncologists will be able to order the assay through their pathology services directly from med fusion.

The TheraLink™ HER Family Assay measures the total amount and activation (phosphorylation) status of 14 critical proteins, receptors and signaling pathway members, providing actionable information for ten currently marketed therapeutics. Starting with a few histopathology sections taken from a core needle biopsy or open resection, the assay is a reverse-phase immunoassay that leverages the extreme sensitivity and precision of microarray technologies to measure these very low abundance proteins, with analyte-specific quantitation provided by on-array calibration samples along with positive and negative controls. The assay provides oncologists with actionable information on drug targets, directly linking active drug targets and the available therapies to identify the most effective personalized treatment options.

“We believe med fusion provides Theranostics Health with a unique opportunity to advance the use of the TheraLink™ Assays,” says Glenn Hoke , President and CEO of Theranostics Health. “Through relationships with their founders, including the McKesson family of health care companies and the Baylor Healthcare System, med fusion provides Theranostics Health with a strong marketing and distribution partner to ensure these assays find utility in the clinical setting.”

“Signal pathway analysis provides some of the most relevant information for targeting cancer therapies,” says Gary L. Smith , Ph.D., Interim CEO and Chief Operating Officer of med fusion. “Furthermore, our collaboration with Theranostics and PBM continues to support med fusion’s model of developing and creating strategic alliances that expand our offering of personalized diagnostic testing services within a patient-centric model of care delivery.”

Source: PR Newswire

TCGA Study Brings Ovarian Cancer Patients Closer to Personalized Medicine

In the June 30 issue of Nature, researchers from The Cancer Genome Atlas (TCGA) Research Network provide a large-scale integrative report on genetic mutations and pathways that distinguish the most common and aggressive type of ovarian cancer from other types of ovarian cancer as well as from other solid tumors. The disease is not defined by one or few cancer-driving genes but rather numerous mutations that individually occur in only a small number of cases. Given the degree of genomic disarray, the study results suggest that genomic structural variation is the driver of ovarian cancer. The findings may be helpful in guiding physicians to choose experimental treatments that are most likely to target molecular alterations effectively in patients with high-grade serous ovarian adenocarcinoma.

Expression Pathology Provides Roche Biomarker Assay Services for Oncology Drug Development

Expression Pathology recently announced an agreement with Roche to provide its Liquid Tissue-SRM Technology to accelerate identification of cancer molecular markers for developing more effective treatments.