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Snippets: Jan 21, 2009


DeCode Sells Auction Rate Securities to Bank

DeCode Genetics said this week that it had sold to Icelandic bank NBI its auction rate securities for a price of $11 million.

Under terms of the sale, DeCode has a call option to require NBI to sell the securities back to the firm at any time prior to Dec. 31, 2009, while NBI has a put option to require DeCode to repurchase the securities following the sale of certain other DeCode assets, or if not previously repurchased, on Dec. 31, 2009.

Reykjavik, Iceland-based DeCode took a $7.7 million charge in its fourth quarter of 2007 related to impairment of its auction rate securities. At the time, CEO Kari Stefansson said, "Obviously, we are not happy with the illiquidity of the auction rate securities. However, we are taking the appropriate measures in an attempt to recover the money invested in them."

The firm also said in the statement that it was continuing to reduce expenses while evaluating "strategic alternatives, including corporate partnerships and the sale of assets. DeCode believes that the proceeds from the sale of the auction rate securities will be sufficient to sustain operations into the second quarter, enabling the company to complete its strategic review and to pursue the best opportunities emerging from this process without seeking additional financing."

NBI is a state-run bank that was formed in October 2008 to take over the insolvent Landsbanki, which was formerly one of Iceland's biggest banks.

NIH to Give Post-GWAS Cancer Studies $24M per Year

The National Cancer Institute will give up to $96 million over four years to support multicenter collaborations that will use data from genome-wide association studies to identify regions in the human genome that are associated with cancer susceptibility.

The program, "Transdisciplinary Cancer Genomics Research: Post-Genome Wide Association Initiative," will spend as much as $24 million per year to support between five and eight awards.

NCI said in a funding announcement that it wants the project to "provide a rigorous knowledge base that would enable clinical translation and public health dissemination of the GWAS findings."

The institute specifically wants to fund transdisciplinary research projects that will take advantage of the existing genome-wide association studies of cancer by exploiting previously generated GWAS data, and those that will accelerate and coordinate integrative post-GWAS discovery research. Each application should include two or three sub-projects that are "closely pertinent to a single unifying research theme," NCI said.

NCI wants researchers to focus on using data from GWA studies because they are "a powerful method" for detecting effects of high-frequency genetic variants linked to cancer susceptibility. But using GWAS-derived information for genetic testing could lead to confusion and harm, NCI said, so "it is imperative to accelerate the post-GWAS research phase" from discovery to replication studies and on to validation of GWAS findings.

All of the programs funded under this program "must be focused on the post-GWAS research on the significance of genomic variants in specific cancer types."

Of primary interest are projects that study variations in cancers of the breast, colon, prostate, pancreas, lung, melanoma, and bladder, said NIH. Some research components are required, NCI said, and each applicant is "strongly encouraged" to propose sub-projects that address three main areas.

They should involve "discovery expansion and replication," which would include finding new associations through pooled or meta-analyses, independent replication studies, and fine mapping of association signals. The research should involve biological studies that will identify risk-enhancing genetic variants, examine the functional consequence of a genetic variant, and determine biological mechanisms of risk enhancement. These studies also should include epidemiologic studies, such as those that evaluate gene-gene and gene-environment interactions, assess penetrance and populations of attributable risk, develop complex risk models, and evaluate clinical and analytic validity of risk models in observational studies.

Researchers receiving funding under these programs also must agree to data-sharing requirements.

More information about the NCI program is available here.

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EGAPP Issues Cancer Genetic Test Recommendations

The independent Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group (EWG) has released a cautious set of recommendations about the validity and utility of three genetic tests or methods that are aimed at healthcare providers, public health practitioners, policy makers, and consumers.

EGAPP is an initiative that was established by the Office of Public Health Genomics at the US Centers for Disease Control and Prevention.

After conducting an evidence-based analysis, EWG said it could recommend offering genetic testing for Lynch syndrome to newly diagnosed colorectal cancer patients, but that it did not find enough evidence to recommend for or against two other types of genetic tests, for breast cancer and metastatic colorectal cancer. The effectiveness of these tests was studied for analytical validity, clinical validity, and clinical utility.

The CDC on Friday released three new papers, which evaluated tests for Lynch syndrome for use in colorectal cancer cases, for using tumor gene expression profiles for certain breast cancer patients, and for the routine use of UGT1A1 genotyping in patients with metastatic colorectal cancer.

EWG found sufficient evidence to recommend genetic tests for Lynch syndrome to individuals with newly diagnosed colorectal cancer to reduce morbidity and mortality in relatives, but the group found insufficient evidence to recommend a specific genetic testing strategy among those the group examined.

The group constructed a chain of evidence linking the genetic testing for Lynch syndrome with improved health outcomes in their relatives. EWG concluded that there is "moderate certainty that such a strategy would provide moderate population benefit."

EWG said it did not find evidence to recommend for or against using tumor gene expression profiles to improve outcomes in defined groups of women with breast cancer. While the group found preliminary evidence of potential benefit to some women facing certain treatment options, it could not rule out the potential harm for others. Those findings left the group with insufficient evidence to assess the benefits versus the harms of the proposed uses of the tests, said the group.

Some performance data were available for MammaPrint, which is made by Agendia, and Genomic Health's Oncotype DX test, although estimates about sensitivity and specificity could not be made. For Oncotype DX, the EWG found "adequate evidence" regarding disease recurrence and response to chemotherapy.

The working group also found "adequate evidence" to characterize the association of MammaPrint with future metastases, but inadequate evidence to assess the added value to standard risk stratification, and it could not determine the best population for the test.

The EWG found no evidence regarding the clinical utility of MammaPrint and Quest Diagnostics' H:I test, and "inadequate evidence" for Oncotype DX.

"These technologies have potential for both benefit and harm," the group said, adding that there is a need for "further development and evaluation."

EWG also did not find enough evidence to recommend for or against the routine use of UGT1A1 genotyping as way of avoiding adverse reactions to the drug irinotecan for patients with metastatic colorectal cancer.

The group found no intervention trials showing that targeted dosing of the drug based on UGT1A1 genotyping could reduce the rates of two specific adverse events, severe neutropenia or diarrhea.

Although observational studies have found "a significant association" between certain genotypes and the occurrence of severe neutropenia and a possible, but not statistically significant, association with severe diarrhea, the group also found that reducing the drug's dosage could result in reducing effectiveness of the treatment, and may harm the patients. Likewise, a higher dosage of the drug could be warranted among individuals who are at lower risk of adverse drug events.

The preliminary models suggest that "even if targeted dosing were to be highly effective, it is not clear that benefits (reduced drug events) outweigh harms (unresponsive tumors)."

The recommendations are published in the current issue of Genetics in Medicine.

ASCO Encourages KRAS Test for Colorectal Cancer Treatment

The American Society of Clinical Oncology is advising doctors treating colorectal cancer patients to test for a variant of the KRAS gene that may predict poor response to available treatments.

ASCO last week offered its preliminary recommendation based on recent studies concerning genetic testing for KRAS mutations, and the effectiveness and cost of the drugs cetuximab (marketed as Erbitux) and panitumumab (marketed as Vectibix), which are based on anti-EGFR antibodies.

If a patient has a mutated form of the KRAS gene, ASCO recommends against anti-EGFR antibody therapy because recent studies suggest it is effective only in people with the normal form of the gene.

As many as 40 percent of colon cancer patients have the KRAS mutation, ASCO said in its provisional clinical opinion. ASCO also said that routine testing for KRAS mutations in patients with metastatic colorectal cancer could save the US health system up to $604 million per year from the cost of the drug cetuximab alone.

"Basing cancer treatment on the unique genetic characteristics of the tumor or the individual with cancer will improve patient outcomes and help avoid unnecessary costs and side effects for patients who are unlikely to benefit," ASCO President Richard Schilsky said in a statement.

Using KRAS testing to guide colorectal cancer treatment is a prime example of where cancer care is heading," Schilsky added.

ASCO said its opinion paper will be published in the upcoming Journal of Clinical Oncology.

Filed under

The Scan

Drug Response Variants May Be Distinct in Somatic, Germline Samples

Based on variants from across 21 drug response genes, researchers in The Pharmacogenomics Journal suspect that tumor-only DNA sequences may miss drug response clues found in the germline.

Breast Cancer Risk Gene Candidates Found by Multi-Ancestry Low-Frequency Variant Analysis

Researchers narrowed in on new and known risk gene candidates with variant profiles for almost 83,500 individuals with breast cancer and 59,199 unaffected controls in Genome Medicine.

Health-Related Quality of Life Gets Boost After Microbiome-Based Treatment for Recurrent C. Diff

A secondary analysis of Phase 3 clinical trial data in JAMA Network Open suggests an investigational oral microbiome-based drug may lead to enhanced quality of life measures.

Study Follows Consequences of Early Confirmatory Trials for Accelerated Approval Indications

Time to traditional approval or withdrawal was shorter when confirmatory trials started prior to accelerated approval, though overall regulatory outcomes remained similar, a JAMA study finds.