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Truven Health Analytics Links Clinical Data with Claims to Enhance Oncology Outcomes Research

Truven Health Analytics recently announced it has successfully linked electronic medical records (EMR) and administrative claims data with significant volume to power oncology-focused outcomes research studies. This de-identified data set, the newest addition to the MarketScan® research databases, provides a unique ability for researchers to better understand total healthcare costs, co-morbidities, adverse events, and outcomes for cancer patients by treatment phase, biomarker status, and tumor stage.

ASCO and the CAP Release Updated Guideline on HER2 Testing in Breast Cancer

The American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP) recently issued a joint, updated guideline aimed at improving the accuracy and reporting of human epidermal growth factor receptor 2 (HER2) testing in patients with invasive breast cancer. The guideline update is based on a systematic review of medical research literature, providing oncologists and pathologists with detailed recommendations for how to test for HER2 overexpression, interpret the results, and recommend HER2-targeted therapies. The guideline, originally issued in 2007, is being published in ASCO’s Journal of Clinical Oncology (JCO) and the CAP’s Archives of Pathology & Laboratory Medicine. The joint guideline was prepared by an ASCO/CAP Update Committee consisting of experts in breast cancer and cancer biomarkers.

Rancho BioSciences Partners with OmicSoft for Manual Data Curation

Rancho BioSciences, the leading manual data curation company for genomic and clinical data recently announced that they will partner with OmicSoft, an industry leading provider of enterprise solutions for next-generation sequencing and Omics data analysis, management, and visualization. Rancho BioSciences and OmicSoft will collaborate on customer driven projects to curate data in order to make it analysis ready, leveraging Rancho BioSciences global team of PhD and MD curators and OmicSoft tools and databases for biomarker data management, visualization, and analysis. OmicSoft software is powerful but easy to use, allowing the bench scientist, bioinformatician and statistician to all benefit from the same tools.

NanoString Technologies Receives FDA 510(k) Clearance for Prosigna Breast Cancer Prognostic Gene Signature Assay

NanoString Technologies, Inc., (NASDAQ: NSTG) a provider of life science tools for translational research and molecular diagnostic products, recently announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Prosigna™ Breast Cancer Prognostic Gene Signature Assay. Based on the PAM50 gene signature, Prosigna is the company’s first FDA-cleared in vitro diagnostic assay and uses the gene expression profile of cells found in breast cancer tissue to assess a patient’s risk of distant recurrence of disease. The Prosigna Assay is performed using the nCounter® Dx Analysis System, which can be placed in qualified laboratories throughout the United States, empowering oncologists and pathologists to quickly and easily meet the testing needs of their breast cancer patients.

“Receipt of FDA 510(k) clearance for Prosigna marks a key milestone for NanoString and is an important step forward in the treatment of breast cancer. This achievement is a testament to the ongoing dedication and professionalism of our team, and the commitment of our collaborators,” said Brad Gray, President and Chief Executive Officer of NanoString Technologies. “Prosigna illustrates our approach of using nCounter technology to translate genomic discoveries into powerful in vitro diagnostic products, and it represents a significant growth opportunity beyond our robust life sciences research business.”

The Prosigna Assay is intended for use as a prognostic indicator for distant recurrence-free survival at 10 years, and is indicated for postmenopausal women with Stage I/II lymph node-negative or Stage II lymph node-positive (one to three positive nodes) hormone receptor-positive breast cancer who have undergone surgery in conjunction with locoregional treatment consistent with standard of care. For each patient, the Prosigna Assay reports the Prosigna Score (referred to as Risk of Recurrence Score, or ROR Score, in the scientific literature, including the TransATAC study recently published in the Journal of Clinical Oncology ) and a risk category based on both the Prosigna Score and nodal status. Node-negative patients are classified as low, intermediate or high risk, while node-positive patients are classified as low or high risk.

Other key features of the Prosigna Breast Cancer Prognostic Gene Signature Assay include:

  • All-in-one assay consumables, including RNA extraction kits, allowing laboratories to test as little as a single section of formalin-fixed paraffin embedded (FFPE) tumor tissue
  • High-throughput workflow allowing each nCounter Dx Analysis System to process up to 30 patient samples per eight hour work day
  • Automated generation of personalized full-color patient reports that can be quickly and easily shared electronically with ordering oncologists

Bruce Seeley, Senior Vice President & General Manager of Diagnostics of NanoString Technologies commented: “We believe that the compelling clinical data, clear patient reporting, and unique delivery model position Prosigna for success in the U.S. market. By integrating the Prosigna Assay into existing laboratory workflows, we are offering physicians and patients seamless and timely access to clinical insights and a powerful tool that can aid in making more informed treatment decisions.”

Prosigna-enabled nCounter Dx Analysis Systems are expected to be available for placement in high-complexity Clinical Laboratory Improvement Amendments (CLIA) certified laboratories late in the fourth quarter of 2013. Prosigna testing services are expected to be available through qualified U.S. clinical laboratories beginning in the first quarter of 2014.

Source: NanoString Technologies

Unexpected Synergy Between Two Cancer-linked Proteins Offers Hope for Personalised Cancer Therapy

A team of scientists led by Associate Professor Zeng Qi from A*STAR’s Institute of Molecular and Cell Biology (IMCB) have discovered a new biomarker which will help physicians predict how well cancer patients respond to cancer drugs. Having the means to identify patients who are most likely to benefit from currently available cancer drugs not only reduces substantially the healthcare cost for the patient, it could mean saving precious lives by getting the right drugs to the right patient at the onset of the treatment. This study published and featured on August cover of the Journal of Clinical Investigation will boost the development of personalised medicine in cancer care and therapy.

Metastasis is the rapid and uncontrollable spread of cancer cells from the primary tumour to other parts of the body. It is often the leading cause of death in cancer patients. Increasingly, there is evidence to show that in many cancers that have metastasised, a protein called PRL-3 is often found to be present at unusually high levels. Since it was first identified in 1998 by Associate Professor Zeng, several other research groups have found evidence to support the strong link between elevated levels of PRL-3 protein and the metastasis of aggressive cancers in the lung, liver, colon and breast. This cancer-promoting action of PRL-3 makes it an ideal target for cancer diagnostics and treatment.

In this study, the IMCB team discovered a curious synergy between PRL-3 and EGFR, another well-known cancer-linked protein frequently associated with breast and lung cancers in humans. They found that cancer cells with higher levels of PRL-3 not only hyperactivate EGFR, but also develop an ‘addiction’ for it to survive. Consequently, by suppressing EGFR activity with EGFR inhibitor drugs, the scientists observed that cancer cells with higher levels of PRL-3 were more rapidly destroyed. To validate these findings in humans, the team collaborated with Associate Professor Wee Joo Chng from the National University Health System to run an analysis on pre-existing clinical data of colorectal cancer patients. The results confirmed that patients who respond better to EGFR inhibitor drugs were those suffering from cancers with abnormally high levels of PRL-3.

Associate Professor Zeng said, “This unexpected synergy has revealed a vulnerable spot of aggressive cancers and brought new hope of treating PRL-3 driven cancers successfully. The addiction phenomenon we observed in cancer cells is akin to depriving alcohol from an alcoholic, thereby inducing the severe ‘withdrawal effects’. In the same way, by selecting cancer patients with elevated levels of PRL-3 and greater ‘addiction’ of EGFR for anti-EGFR treatment, we can deliver more effective and targeted cancer therapy with the existing EGFR inhibitor cancer drugs.”

Professor Sir David Lane, Chief Scientist of A*STAR said, “This is an excellent example of how years of basic research lay the foundation for advancement in translational and clinical applications. I am pleased that the team is exploring the potentials of developing this new predictive biomarker into a rapid diagnostic kit for identifying patients who will respond favourably to current anti-EGFR treatment. I believe that this study will open new avenues for personalised medicine in cancer therapy.”

Study: Metastasis-associated PRL-3 induces EGFR activation and addiction in cancer cells [Journal of Clinical Investigation]

Source: Agency for Science, Technology and Research (A*STAR)