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Life Technologies and Advanced Cell Diagnostics Sign Global Distribution Agreement

Life Technologies Corporation (NASDAQ: LIFE) and Advanced Cell Diagnostics, Inc. (ACD), a leader in the field of molecular pathology and developer of cell and tissue-based analysis tools, recently announced a global distribution agreement by which Life will distribute ACD’s fluorescent RNAscope® portfolio of probes and kits to the research market through its worldwide distribution network.

Independent Study: Health Diagnostic Laboratory, Inc. Services Lead to Cost Savings of 23% and Significantly Improved Health Outcomes After Two Years

Advanced cardiometabolic testing paired with follow-up health management from Health Diagnostic Laboratory, Inc. has resulted in a 23 percent decrease in a patient’s overall healthcare costs and an improved lipid profile in just two years, according to a new independent study published recently in Population Health Management.

Gentris Corporation Launches Next Generation Human Transcriptome Array

Gentris Corporation (www.gentris.com), a global leader in pharmacogenomics and biorepository solutions, recently announced that it is expanding its genomic biomarker offering with the launch of Affymetrix GeneChip(R) Human Transcriptome Array (HTA) services. The GeneChip(R) HTA is a high resolution microarray for gene expression that is designed to empower next-generation expression profiling studies. The new array goes beyond gene-level expression profiling by providing the coverage and accuracy required to detect all known transcript isoforms produced by a gene.

Biomarker May Predict Prostate Cancers Requiring Treatment

Not all early-stage prostate cancer diagnoses are alike. While some patients have aggressive tumors, others have slow-growing, low Gleason score tumors that may not require treatment, but instead can be monitored with regular clinical evaluations. But distinguishing between prostate cancers that require treatment and those that do not is still a major challenge.

Researchers at Columbia University in New York City have now identified a 3-gene signature that could indicate whether a particular early-stage prostate cancer is indolent. The test relies on a tissue sample, and along with a prostate-specific antigen (PSA) test and a histology assessment, could help clinicians make an accurate diagnosis. The early results, including a blinded retrospective analysis of 43 patients, show that the signature can accurately predict which patients with low-risk disease would develop metastatic prostate cancer and which patients would not progress. The study is published in Science Translational Medicine.

“These types of markers will, for the first time, give us the opportunity to measure biological features of cancer in the same patient, with multiple biopsies spread out over many years,” said Eric Klein, MD, chairman, Glickman Urological and Kidney Institute at the Cleveland Clinic in Ohio.
Cory Abate-Shen, PhD, professor of urological oncology at Columbia University; Andrea Califano, PhD, professor of systems biology at Columbia University; and colleagues used a computational approach that identified three genes—FGFR1, PMP22, and CDKN1A—all associated with aging, that could accurately predict outcomes of low-risk, low Gleason score prostate tumors. Protein and mRNA levels of all three genes were high in those patients who had non-aggressive, indolent disease and low in those who had aggressive tumors.

Clinicians still rely on the Gleason score, a histology and pathology evaluation that does not incorporate any molecular assessment. Those patients with a Gleason score of 8 or higher are candidates for immediate treatment, but whether men with a score of 6 or 7 require treatment is difficult to assess—no test exists to identify the small percentage of patients who have early-stage prostate cancer that is more likely to metastasize.

The 3-gene signature was validated using an independent prostate cancer cohort. According to the study authors, the signature was prognostic and improved prognosis compared with the use of PSA and clinical assessment.

“We would predict that the test would be beneficial for patients with low Gleason score prostate tumors,” said Abate-Shen. “These patients are now typically monitored on active surveillance protocols, and the patients get a biopsy periodically. The test would be conducted on the biopsy.”

Rather than focusing on the entire genome, the researchers focused on 377 genes involved in aging, predicting that genes involved in aging and senescence are critical for tumor suppression. Cellular senescence is known to play a role in tumor suppression and is associated with benign prostate tumors both in the clinic and in mouse models, according to the researchers. Using a computational analysis called gene set enrichment analysis (GSEA), they narrowed the long gene list to 19 genes, and then to a set of 3 genes that could identify indolent tumors.

“To focus on senescence genes is intellectually interesting,” said Klein. “There is already a body of work supporting the role of these genes in prostate cancer, but to my knowledge no one has looked at them in early-stage disease before.”

Forty-three patients, who had been under active surveillance for 10 years at Columbia University Medical School, were used for the blinded retrospective analysis to assess the predictive value of the gene signature. Each patient had been diagnosed with low-risk prostate cancer, with a Gleason score of 6 or less. The test was correctly able to identify all 14 patients who eventually developed advanced prostate cancer.

CDKN1A has been shown to be linked to senescence and to regulate the cell cycle. Previous studies have shown that downregulation of the gene is linked to cancer progression. The correlation of FGFR1 (fibroblast growth factor receptor 1) with indolent tumors was surprising, as fibroblast growth factors have been shown to play a role in prostate cancer development. But, as the authors highlight in their discussion, FGFR1 signaling in prostate cancer is likely complex. The third gene in the signature, PMP22, encodes a glycoprotein expressed in neurons and has not been previously associated with prostate cancer.

This 3-gene signature is different from previously identified biomarkers, which have largely focused on advanced tumors. The potential biomarker test could complement other approaches in development, such as urine or blood tests, according to the authors.

A trial to validate the genetic signature is underway at Columbia University, and a national trial is being planned.

“It is really important to find novel ways to help to define early-stage tumors that may or may not progress to aggressive disease,” said Abate-Shen. “This will ultimately really help to minimize overtreatment, while capitalizing on the benefits of cancer screening.”

Other genomic approaches to distinguish indolent and aggressive disease are also underway. The first-generation expression-based tests, including Oncotype DX prostate and Prolaris, can facilitate clinical decisions based on the molecular characteristics of a prostate tumor. Both the available tests and the new ones “promise to reduce overtreatment and help men make the right decisions based on biology rather than uncertainty,” said Klein. 

Study: A Molecular Signature Predictive of Indolent Prostate Cancer [Science Translational Medicine]

Source: CancerNetwork

Quintiles Asks, ‘Why Not Test for Many Biomarkers at Once?’ When Evaluating Therapies for Cancer Patients

Calling the concept “pre-profiling,” Quintiles (Research Triangle Park, NC) is collaborating with US Oncology Research (the research arm of McKesson Specialty Health) to test the value of running multiple biomarker tests at once for cancer patients—in this case those with metastatic colorectal cancer (mCRC). Either for initial therapy, or as a step to selecting candidates for clinical trials, the current practice is to look for genomic data that is relevant to one type of therapy; if the suitable genomic variant is found, the clinician then knows that the patient is a good trial candidate, or that the patient could benefit from a specific therapy. Quintiles is suggesting to look at many variants or makers initially and then make treatment or trial recruitment decisions.

In practice, says Dr. Jeffrey Spaeder, CMO at Quintiles, a biopsy would be retrieved from the patient, DNA and other genomic information sequenced, abnormalities identified, and bioinformatics analysis conducted, then returning the results back to the clinician. “All these steps sound intuitively straightforward, but they involve complex handoffs of information and clinical decisions,” he says. Understanding what the clinician can do with the data needs to be determined; what choices the patient might have for one therapy or another; and in the final analysis, whether better outcomes could be achieved remain to be evaluated. Eventually, the multiple-biomarker process could become a step in the clinical pathways that various organizations have developed for treatment of cancers. “Early indications from this study suggest that we can provide physicians and patients with early visibility on potentially clinically actionable biomarkers within a rapid two-week timeframe. This level and speed of analysis has promise to save valuable time in administering potentially life-saving therapies to patients, and reduce the development times of precision medicines.”

The biomarker field, while demonstrating exciting new potential and spurring the evolution of personalized (or “precision”) medicine, is fraught with operational difficulties. Insurers are selective about what biomarker tests they are willing to pay for; practitioners have varying enthusiasm for the tests, and the clarity around which tests lead to beneficial outcomes are not clear. Even so, this study could be one of a series of medical innovations to make biomarkers a standard element of cancer therapy.

Source: Pharmaceutical Commerce