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Snippets: Apr 22, 2009


GPPC Lands $750K Pew Grant

The Genetics and Public Policy Center at Johns Hopkins University has been awarded $750,000 from the Pew Charitable Trust to conduct studies of what, if any, steps should be taken toward creating consumer protections in relation to genetic testing.

The main focus areas for the Consumer Genetics Project will include whether or not the Food and Drug Administration should incorporate genetic testing information into drug labeling, a new point program for GPPC. The center also said that it will continue to focus on the truth of claims made by genetic testing companies, and issues surrounding genetic discrimination.

GPPC Director Kathy Hudson said in a statement that since the center began studying genetics-related policy issues "the technology and business environments for genetic testing have changed dramatically, creating new opportunities for protecting the consumer public and ensuring genetic testing quality. While we will need to continue efforts to ensure that needed and now widely endorsed regulatory reforms are implemented to ensure tests' accuracy and validity, new measures are needed to protect consumers from harm and to reap the benefits of genetic testing."

GPPC, which was established with a Pew grant of $10 million to Johns Hopkins University in 2002, said that adverse drug reactions are responsible for 100,000 deaths and over 2 million hospitalizations each year in the US, at an estimated cost of between $1.5 billion and $4 billion. But "there have been few examples of pharmacogenetic information being translated successfully into clinical care," GPPC said.

While FDA has put out guidance documents showing that it "appreciates the value of pharmacogenetics to foster its mission of protecting public health, the agency has not developed a clear pathway" to include pharmacogenetic information on labels, noted GPPC.

"We are evaluating the amount of evidence required by FDA to support labeling changes, the amount of time required to implement such changes, and the clarity of communication about the implications of the information for clinical care," added GPPC Law and Policy Director Gail Javitt said in a statement.

The center said it will continue to study the truth in advertising about genetic testing marketed directly to consumers.

Javitt said that the center has found that "companies are making scientifically unsupportable claims and consumers are putting their health and their pocketbooks at risk."

Although the Federal Trade Commission could regulate the industry, the agency "has taken no action to date on advertising claims about genetic tests," Javitt added.

NCI to Use Budget Bump to Expand Genomics, PHC

The National Cancer Institute has put in place its outline for how it plans to spend the three percent increase it received in the 2009 budget and the extra funding it expects to receive from the American Recovery and Reinvestment Act, NCI Director John Niederhuber said this week.

As part of the $10.4 billion in the ARRA for NIH, $1.3 billion is marked to go to NCI over between 2009 and 2010.

At a meeting of the American Association for Cancer Research in Denver, Niederhuber described "an accelerated cancer genetics program," the development of "a platform for personalized cancer care," and more research grants "that will move cancer research forward in this new economic environment," as key recipients for funding.

The NCI initiatives include an expansion of the Cancer Genome Atlas (TCGA) program, a personalized healthcare platform, more grants to first-time investigators, and an increase in support for universities to use in training and assisting new faculty investigators, Niederhuber said.

"We must hasten our progress against cancer by conducting exciting new science, which this year's increase in funding, in addition to anticipated funds from the American Recovery and Reinvestment Act, will help make possible," Niederhuber said in a statement. "Because cancer research contributes to the diagnosis and treatment of many other major diseases, we anticipate NCI's efforts will lead to scientific advances necessary to improve the nation's health."

He noted that TCGA has identified three genes not previously associated with glioblastoma and has delineated as many as four subtypes of glioblastoma to date.

"With that foundation of success, we plan to move TCGA forward, with a goal of identifying all of the relevant genomic alterations in 20 to 25 major tumor types," he added in prepared statements made for his announcement at AACR.

According to an NCI statement, the personalized cancer care platform will be "based upon the knowledge that cancer is a disease of altered genes" and that it will be designed to "encompass and enable drug development, from discovery of genetic changes to clinical applications for patients."

Two other measures NCI will institute include an increase in the pay line that would make it possible to "fund a greater number of meritorious investigator-initiated projects," and a "new network of Physical Sciences-Oncology Centers to explore new and innovative approaches to better understanding and controlling cancer through the convergence of the physical sciences with cancer biology."

NCI recently outlined its major priority areas for public health genomics research, which included some comparative effectiveness research of the use of genomic markers in cancer care, pharmacogenomics studies, genomics in translational cancer research, development of candidate genomic applications for cancer prevention, management, and prognosis, and several other major priority areas.

Niederhuber said that the stimulus funds present an opportunity to "demonstrate that NCI is worthy of sustained, increased support for years to come," and that the institute should use the funds to lead "with a clear direction that will hasten the pace of cancer research."

The stimulus funding and the Federal budget funding "must not be mixed," the director continued, saying that "there are different rules, in many cases, of what can be funded from which pot of money." Because of the unique nature of the ARRA funds, "recipients of the stimulus funds will also have some stringent requirements, particularly around reporting on your stewardship of these dollars," Niederhuber explained.

NCI's plan to fund early-stage investigators involved in translational research "will assist young faculty members in establishing laboratories; in creating a foundation for a career of excellence," he said. A parallel program will be available for NCI-Designated Cancer Centers and at institutions funded through the Minority Institution/Cancer Center Partnership program.

The TCGA and the Therapeutically Available Research to Generate Effective Treatments program currently "are generating a mountain of data and revealing potential genetic defects that occur within cancer," said Niederhuber. Taking that data and moving it toward a therapy "will not be simple, nor will it be easy or inexpensive," he said.

The plan includes the creation of functional biology centers, including a virtual network of researchers that will use data from TCGA and answer specific questions about biologic function and potential druggable targets. "High throughput screening will follow, using appropriate assays, to compare the vast libraries of compounds to newly defined targets," he said.

NCI will use its caHUB program to manage the scale-up of the TCGA and to handle the genetic characterization of patients, while the NIH Clinical Center, the SPORE Program, the Community Cancer Centers Program, and others, "will all be key players in establishing a highly-characterized national cohort of patients who can be easily matched with potential new agents."

Niederhuber also called for an improved clinical trials system, "to better accommodate the validation of highly targeted therapies and to accurately assess the targeting of those therapies in patients in real time."

Matt Jones, GenomeWeb Daily News

Satoris, RayBiotech to Co-develop Alzheimer's Test

Satoris will collaborate with RayBiotech to develop array-based test kits for Alzheimer's disease, the firms said last week.

Satoris, a Redwood City, Calif.-based molecular diagnostics company that has developed a panel of 18 biomarkers that predicted the presence of Alzheimer's disease in test sample sets with up to 90 percent accuracy, will collaborate with RayBiotech, a developer and supplier of multiplex protein detection arrays and array-based test kits.

Under the collaboration, the 18 biomarkers will be applied to the RayBiotech Quantibody array platform. After the array-based test is validated for performance, it will be commercialized later this year as a research-use-only test. Norcross, Ga.-based RayBiotech will market the test, and Satoris will use the array along with proprietary bioinformatic analysis tools to offer a testing service.

"We expect this blood test will be well received as a valuable tool in Alzheimer's research and, potentially, as a diagnostic test as well," said Ray Huang, RayBiotech's president, in a statement. "Using antibody-based approaches, more biomarkers can be identified, validated, and put into clinical application faster and cheaper than with traditional methods based on mass spectrometry."

NCI to Fund Prognostic Biomarker Studies

In order to address what it describes as a need for more biomarker-based products aimed at predicting cancer and its advancement and predicting patient response, the National Cancer Institute has put out a new grants program to fund biomarker development.

The program, Developmental Research in Cancer Prognosis and Prediction, funds both R21 and R33 grants aimed at developing new biomarkers from initial observations into assays or test systems for use in clinical trials.

The R21 grants will award up to $275,000 over a two-year period, and the R33 program will be held to a three-year period and will have a budget that is "appropriate for the science proposed."

The goal of the R21 program is to continue development of novel prognostic and predictive biomarkers towards laboratory assays and test systems that can be used in clinical trials or in larger studies.

The R33 program aims to develop biomarkers into assays or test systems for cancer in clinical trials or other types of confirmatory clinical research studies.

"Despite strong interest in biomarkers and a growing body of knowledge, the number of clinical laboratory assays currently in routine use in oncology remains very small," NCI explained in a funding announcement. NCI said that although the R21 grants will fund "rapid appraisal of new candidate prognostic and predictive markers."

NCI said that although there is an increasing number of new molecules and new patterns of gene expression that are correlated with prognostic factors, "very few biomarkers progress beyond the stage of an initial promising result. Studies to move the development of a new diagnostic test beyond the exploratory stage require both large numbers of patient samples with associated clinical data, robust, efficient assays/techniques, and substantial statistical input," said the institute in the funding announcement.