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Biomarker Identification May Lead to New Noninvasive Test for Colorectal Cancer Detection

The average 5-year survival for colorectal cancer (CRC) is less than 10% if metastasis occurs, but can reach 90% if detected early. A new non-invasive test has been developed that measures methylation of the SDC2 gene in tissues and blood sera. This test detected 87% of all stages of colorectal cancer cases (sensitivity) without significant difference between early and advanced stages, while correctly identifying 95% of disease-free patients (specificity). The results are published in the July issue of The Journal of Molecular Diagnostics.

According to the US Centers for Disease Control and Prevention, CRC is the second leading cancer killer in the US affecting both men and women. In 2009, close to 137,000 people in the US were diagnosed with CRC, with close to a 40% mortality rate.

There are other screening choices for CRC, including fecal occult blood testing (FOBT), fecal immunochemical testing, and colonoscopy. Colonoscopy is the gold standard of CRC screening, but patient resistance – mostly due to the unpleasant preparation – has curbed widespread adoption. FOBT is non-invasive but has limited sensitivity, particularly for early disease. A sensitive and specific non-invasive test using blood or stool could to be a more preferable option with the potential of saving many lives.

In their search for a biomarker that could be used for the early detection of CRC, investigators from Genomictree, Inc. and Yonsei University College of Medicine in Seoul, South Korea, performed DNA microarray analysis coupled with enriched methylated DNA using tissues from primary tumors and non-tumor tissues from 12 CRC patients. After step-wise filtering, they found a set of genes that were highly methylated across all of the CRC tumors. Ultimately they identified one gene, SDC2, which encodes the membrane syndecan-2 protein, a protein that is known to participate in cell proliferation, cell migration, and is expressed in colon mesenchymal cells. The methylation level of target region of SDC2 assessed in tumor tissue was found to be significantly higher than that from paired adjacent non-tumor tissue.

The next step was to clinically validate the biomarker by analyzing SDC2 methylation levels in primary tumors and paired-adjacent non-tumor tissue samples from 133 CRC patients. Investigators found that in the transcriptional regulatory region of the SDC2 gene, tumor samples showed significantly higher levels of methylation than the control samples. SDC2 methylation positivity ranged from 92.9% to 100% when samples were stratified according to stages of cancer.

Further, investigators found that the SDC2 biomarker could be measured in serum samples from CRC patients and healthy individuals. “The SDC2 methylation test was able to detect 92% for detection of stage I cancer patients indicating that SDC2 is suitable for early detection of CRC where therapeutic interventions have the greatest likelihood of curing the patient from the disease,” says first author TaeJeong Oh, PhD.

The authors suggest that the SDC2 methylation test they describe could possibly be used as an alternative to or in conjunction with colonoscopy. It could also be used to monitor cancer progression and treatment. Dr. Sungwhan An, corresponding author and CEO of Genomictree, Inc., commented: “We are very excited with this result using a small amount of serum DNA from less than 1ml of blood. I believe a greater volume of blood will further improve the clinical performance of this test. We are currently preparing another set of clinical validation studies evaluating SDC2 methylation in serum DNA from patients with early adenoma.” In future research the authors will explore whether this biomarker is specific to CRC or universal among other cancers.

Source: Gnome-Wide Identification and Validation of a Novel Methylation Biomarker, SDC2, for Blood-Based Detection of Colorectal Cancer

Source: EurekAlert!

Molecular Response Launches TargetXTM Platform for Rapid Discovery & Validation of New Oncology Targets

Molecular Response recently announced the launch of its TargetX platform for rapid discovery and validation of new oncology targets. The program provides partners with access to the world’s largest bank of living tumor specimens, matched genomic database, and in vivo/ex vivo patient derived tumor models for validation. The integrated platform enables investigators to do in days what used to take months.

Target discovery and validation in oncology has largely relied on molecular and functional studies performed in cell lines. Recent advances in genomics have now created large databases based on well-characterized tumor tissue, which has enabled direct investigation of patient tumors for novel targets. Following these discoveries, it is routine to perform functional studies in cell line-based systems; however, it is often challenging to find a relevant cell line model and if found, there are often numerous factors which confound biology when using historical cell lines for functional studies. The result can be a process which takes considerable time and does not readily translate to clinical relevance.

“TargetX is the largest scale genomic database matched to living patient-derived tumor models,” said Dr. Mohit Trikha, CSO of Triphase Accelerator and founder of Drug Design Corp. “We plan to access it for our drug pipeline development and biomarker identification; having everything in one place allows us to do in days what used to take months. Additionally, we can now work with living patient derived tumor samples rather than cultured cell lines.”

The platform relies on Molecular Response’s proprietary bank of more than 144,000 patient derived tumor cells, of which nearly 400 tumors have been genomically characterized and databased for target discovery studies. The database is growing, but currently features the following cancer indications: colon carcinoma, NSCLC, melanoma, ovarian carcinoma, prostate cancer and Non-Hodgkins Lymphoma. Upon discovery of a novel target, tumors of interest are immediately implanted into mice to perform functional studies in direct patient derived models–either in vivo or ex vivo. Molecular Response currently has more than 60 such patient derived xenograft models established for in vivo studies.

“We continue to focus on the use of patient derived models, both in vivo and ex vivo, for advancing oncology drug development,” said Thomas Broudy, CSO of Molecular Response. “Everybody would like to perform studies in the patient derived tumor setting starting as early as possible, but without the resource to do so, it’s nearly impossible. TargetX now enables you to do that.”

Molecular Response presented results from the TargetX platform at the AACR meeting; the company has identified a novel kinase target for potential therapeutic development. They investigated prevalence of target overexpression across 7 cancer indications, and identified melanoma as a clinical indication of high interest. Growth characteristics from patient tumors featuring high kinase gene expression vs. low expression were examined to help characterize the role of this target in oncology disease progression. Functional studies in these patient derived models to further validate the novel kinase are ongoing, as is a small molecule and antibody-based therapeutic development program.

Source: Business Wire

Selventa Developing Powerful New Class of Multi-omic Based Diagnostic Test for Autoimmune Disease and Cancer

Last week Selventa announced that it is developing a powerful new class of diagnostic test that will accelerate the implementation of personalized healthcare. Systems Diagnostics, or SysDx™, will be a novel diagnostic tests that can consist of “multi-omic” biomarkers selected through a rigorous Big Data analysis of a patient’s biological profile including genomic, epigenomic, transcriptomic, proteomic, metabolomic and electronic medial record information. From this analysis, Selventa will generate a differentiated and clinically-relevant report that physicians and patients can use to improve therapy selection.

PerkinElmer Launches Automated Workstation for Improved Process Development of Protein Therapeutics

PerkinElmer, Inc., a global leader focused on improving the health and safety of people and the environment announced the launch of the JANUS® BioTx ProTM automated workstation for improved process development of protein therapeutics at the 12th Annual Protein Science Week (PepTalk), January 21–25 in Palm Springs, Florida at booth #312. Designed for high throughput, small scale protein purification, it is the only workstation that accommodates multiple chromatography modes (column, tip and batch) eliminating the need for multiple instruments, resulting in more efficient and cost effective sample processing.

Cleveland BioLabs Announces Publication of Studies Identifying Biomarkers of CBLB502’s Efficacy as a Radiation Countermeasure

Cleveland BioLabs, Inc. (Nasdaq:CBLI) recently announced the online publication of studies identifying biomarkers of CBLB502’s efficacy as a radiation countermeasure in the Journal of Pharmacology and Experimental Therapeutics, a leading peer-reviewed research journal in the field of pharmacology. The reported studies were conducted by scientists of Cleveland BioLabs in collaboration with researchers at the Armed Forces Radiobiology Research Institute and the F. Edward Hébert School of Medicine at the Uniformed Services University of the Health Sciences, and Roswell Park Cancer Institute.