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Clinical Data, Spacelabs, HHS, Novartis, NHLBI, FDA, BioImagene

Clinical Data Unit to Provide Services to Spacelabs for Heart Studies
Clinical Data’s Cogenics unit will offer its lab services to Spacelabs Healthcare’s clinical trial services branch to help drug makers test for drug-induced QT prolongation.
Clinical trial services president Jim Roop said this week that the agreement will allow Spacelabs to offer genetic testing services “into all stages of clinical trials.”
Drug-induced QT prolongation commonly slows drug studies because of its link to cardiac difficulties. Clinical Data said that because “several drugs have been pulled from the market as a result of adverse effects related to cardiac safety,” regulators are asking for QT studies before marketing approval.

HHS Secretary Leavitt Discloses Plans to Place Greater Emphasis on Personalized Medicine
The Department of Health and Human Services is developing an agenda that will put extra emphasis on the development of personalized medicine, and will institute initiatives to ensure that genetic tests are safe and accurate, HHS secretary Mike Leavitt said in a speech last week.
Speaking during the Personalized Medicine Coalition’s annual meeting, Leavitt also said the initiative would control access to federal research, build a network that would pool national health care data, and ensure that new technologies and gene-based medical information are used appropriately.
During the speech, made at the National Press Club in Washington, DC, Leavitt heralded pharmacogenomics in general as the future of medicine.
Simultaneously, HHS Secretary’s Advisory Committee on Genetics, Health, and Society released a draft document, Realizing the Promise of Pharmacogenomics: Opportunities and Challenges, outlining the agency position of PGx tools (see articles, in this issue, here and here).
“Personalized health care will combine the basic scientific breakthroughs of the human genome with computer-age ability to exchange and manage data that will give us the ability to deliver the right treatment to the right patient at the right time – every time,” Leavitt said in a statement.
HHS said the initiative has three main goals: to review structures for “ensuring that genetic tests are accurate, valid, and useful” by seeing that HHS departments know their assignments in this area; by developing “consistent policies” to guide HHS agencies in managing “access to and security of federally supported research”; and by creating a “network of networks” that pulls together health care information from “the nation’s major health data repositories” to “enable researchers to match treatments and outcomes.”
Leavitt said HHS is funding personalized health care projects with $277 million in fiscal 2007, and said that support is proposed to increase to $352 million in fiscal 2008.
The HHS already has an Office of Personalized Medicine and an advisory panel that meets regularly to consult and advise on gene-based medical issues.
The Personalized Medicine Coalition is a group of companies and other entities from the health care field. The coalition’s president and chairman, Wayne Rosenkrans of AstraZeneca Pharmaceuticals, said the group is “deeply appreciative” of Leavitt’s leadership “as he makes personalized medicine a national priority.”
The group said its goals are to promote “fair and equitable” payment for diagnostics that promote their advancement, passage of the Genetic Information Non Discrimination Act, and programs to teach providers about new molecular medical approaches.

Novartis to Close NIBR Genome & Proteome Sciences Group, Fold Activities into Other Programs
Novartis is breaking up the Genome & Proteome Sciences program within the Cambridge, Mass.-based Novartis Institutes for Biomedical Research in order to restructure and “refocus” its programs and resources, a spokesman for the company confirmed last week.
The company plans to continue ongoing projects that the department was pursuing, said Jeffrey Lockwood, NIBR’s director of external communications, but noted that most of the staff and programs will be absorbed by other units.
Lockwood said the decision to end the Genome & Proteome program – one of several so-called “expertise platforms” at NBIR -- came after “a regular review,” and said the move is not due to dissatisfaction with the content or cost of the program. 
“The commitment to that area will continue,” Lockwood said of proteomics, genomics, and informatics research. “It is just going to be integrated into another group.” 
Lockwood also confirmed that program head Mark Boguski, who joined NIBR in 2005, will be leaving the company to “pursue other opportunities” at the end of March.

NHLBI Solicits Proposals for Large-Scale Comparative Warfarin Study
NIH’s National Heart, Lung, and Blood Institute is soliciting proposals for a large, multicenter, double-blind, randomized trial comparing approaches to guiding warfarin therapy.
The treatment methods NHLBI would like to compare include: initiation of warfarin therapy based on an algorithm using clinical information and the individual’s genotype; 2) initiation of warfarin therapy based on an algorithm using only clinical information; and 3) a standard, guideline-based initiation strategy.    
According to NIH, the 18-month trial would involve approximately 2,000 participants not previously treated with warfarin and who have “any indication for chronic long term anticoagulation.” Patients would be followed for one year.
“In addition to acquiring genotypic and clinical data, the trial will include detailed measurements of anticoagulation status, collect detailed information on factors (nutritional, pharmacologic and others) influencing the anticoagulation status, and collect quality of life and cost-effectiveness data,” the NIH said in an announcement
The NIH’s Clinical Trial Coordinating Center will oversee the subcontractor who will work on this project. 

FDA Green Lights BioImagene Pathiam Imaging Software for HER2/neu
BioImagene announced last week that it has received clearance from the US Food and Drug Administration for the use of its Pathiam Imaging Software for HER2/neu for in vitro diagnostic use.
BioImagene’s Pathiam is intended to be used in conjunction with Dako’s HercepTest to assist with semi-quantitative measurement of HER2/neu in breast cancer tissue.
According to the company, the software detects and classifies cells in breast cancer tissue by analyzing digitized images.
Following approval of its product, the company said that “interest from pathologists for Pathiam has been very strong and it shows the growing market adoption for our digital pathology solutions.”  

Filed under

The Scan

Positive Framing of Genetic Studies Can Spark Mistrust Among Underrepresented Groups

Researchers in Human Genetics and Genomics Advances report that how researchers describe genomic studies may alienate potential participants.

Small Study of Gene Editing to Treat Sickle Cell Disease

In a Novartis-sponsored study in the New England Journal of Medicine, researchers found that a CRISPR-Cas9-based treatment targeting promoters of genes encoding fetal hemoglobin could reduce disease symptoms.

Gut Microbiome Changes Appear in Infants Before They Develop Eczema, Study Finds

Researchers report in mSystems that infants experienced an enrichment in Clostridium sensu stricto 1 and Finegoldia and a depletion of Bacteroides before developing eczema.

Acute Myeloid Leukemia Treatment Specificity Enhanced With Stem Cell Editing

A study in Nature suggests epitope editing in donor stem cells prior to bone marrow transplants can stave off toxicity when targeting acute myeloid leukemia with immunotherapy.