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FDA, BioArray Solutions, International Sequencing Consortium, ABI, Broad Institute, Rockefeller University, British Embassy, Gene Logic, Quest, Correlogic


Organizations Call for Genomics — Not
Race — to Guide FDA Approval of BiDil

Anticipating an FDA committee meeting scheduled for this week to discuss the application for the heart failure drug BiDil, a coalition of several organizations this week expressed concern that the treatment has been characterized as "race-specific," and called for additional clinical trials that will take a closer look at the genomic basis for patient response.

The organizations said today that they are forming a commission to advance personalized medicine based on molecular data, rather than race, which the groups dubbed a "proxy for biology" in a statement issued this week. These groups include the National Minority Health Month Foundation, the Alliance of Minority Medical Associations, the Association of Black Cardiologists, the Genetic Alliance, the International Society on Hypertension in Blacks, the Joint Center for Political and Economic Studies, the Health Policy Institute, the National Association for the Advancement of Colored People, and the National Medical Association.

The newly formed National Commission on Health, Genomics, and Human Variation will take steps to "develop a comprehensive strategy, speak out on the application of 'social race' in medical advances, and encourage additional clinical trials with significant minority representation," said Gail Christopher, vice president of the Office of Health, Women, Family, Joint Center for Political and Economic Studies, in a statement. Christopher will serve as co-chair of the commission.

BiDil's ties to social race stem from the African American Heart Failure Trial (A-HeFT), which tested the NitroMed drug in 1,050 patients who self-identified as African American/Black. The trial showed that patients taking BiDil (isosorbide dinitrate/hydralazine) experienced a 43-percent increase in survival, a 39-percent reduction in the rate of first hospitalization for heart failure, and an improved quality of life.

But Ngozi Robinson, director of health disparities initiatives at the Genetic Alliance, said in a statement that the trial used race "as a proxy — a profoundly imperfect one — to identify patients who might find benefit in this particular drug."

As an alternative, "We strongly encourage Phase IV monitoring or testing to determine at the cellular level patients that would benefit from BiDil," Robinson said. "Through the development of a test to indicate the patient's molecular sensitivity to BiDil, we know that all those who benefit from BiDil will get it and that they will be responsive."

Christopher called for a "larger study" to examine BiDil "in a heterogeneous population with the same clinical presentation or diagnosis — stage 3 and 4 cardiovascular disease," adding that "race-based claims are not credible in the face of modern genetic science."

BioArray Solutions Gets FDA
Clearance for Bead Array Immunoassay

BioArray Solutions has received clearance from the US Food and Drug Administration for a bead array-based multiplexed immunoassay, the Warren, NJ-based company said this week.

The 510(k) clearance covers the company's IgG BeadChip test system, an immunoassay for the simultaneous detection of six antibodies to different extractable nuclear antigens. The test will be used with BioArray's Array Imaging System, AIS 400, which employs a chip format for detection.

BioArray Solutions is currently developing other assays for protein and DNA analysis to run on its platform.

International Sequencing Consortium Sets Out to
Tackle 16 Billion Base Pairs of Wheat Genome

An international group of scientists from academia, industry, and government agencies has formed the International Wheat Genome Sequencing Consortium to analyze and sequence the genome of wheat, the organization said last week.

The group aims to develop a physical map as well as sequence the common wheat genome, which is hexaploid and has 16 billion base pairs. Initially, the WGSC will focus on sequencing a region of wheat that is rich in agriculturally important traits, such as resistance to fusarium head blight, glume blotch, and rust, and tackle portions of the physical map.

The consortium, which is co-chaired by three scientists from the US, Australia, and France, is open to individuals and organizations supporting its goals. The Kansas Wheat Commission and Kansas State University, which spearheaded its formation, will cover the start-up costs of the executive director and web services.

Fifty scientists from eight countries participated in the WGSC's first meeting, held earlier this month in Bozeman, Mont.

ABI Sells DNA Analyzers to Broad Institute, Says Capillary
Electrophoresis Remains 'Gold Standard' for Sequencing

Applied Biosystems has sold approximately 20 capillary electrophoresis DNA sequencing instruments to the Broad Institute of MIT and Harvard, the company said today.

The purchase of the 3730xl DNA Analyzers brings the institute's number of instruments of this type to 126. The Broad plans to use the analyzers to sequence new genomes and to perform genotyping studies.

ABI interprets the sale as a sign that the days of traditional DNA sequencing are not yet numbered, despite the company's expectation that revenues from its sequencing business will decline in the future, and the Broad's purchase in March of a next-generation sequencing instrument from 454 Life Sciences.

"Broad's choice of the 3730xl instruments is confimation that capillary electrophoresis remains the gold standard in DNA analysis technology today," said CSO Dennis Gilbert in a company statement. ABI said it continues to invest in the development and enhancement of capillary electrophoresis technology.

Rockefeller Donates Record $100M to Rockefeller
University; Genomic Research to Benefit

David Rockefeller, honorary chairman and life trustee of the University's Board of Trustees, has pledged $100 million to the University, the largest gift in its history, the school said last week.

The gift will enable the university to expand its research "in areas such as genomics," as well as stem-cell research, aging, and neurology, according to Russell Carson, chairman of the university's Board of Trustees.

The school will use $30 million of the gift to help support its newly named David Rockefeller Graduate Program. Additionally, $70 million of the gift will go to help the school restore some of its lab buildings and to support research on the North side of the University's campus.

British Gov't Seeks Proposals for UK-Japanese
Structural Genomics Collaboration

The British Embassy in Tokyo is seeking proposals to support the initial stages of new collaborations between UK and Japan researchers in the field of structural genomics, the UK government said last week.

Proposals should be submitted by July 15.

Gene Logic Finishes Expanding Facilities for
Contract Study Services, Nonclinical Testing

Gene Logic has finished expanding its contract study services facility, the company said last week.

The firm said its general toxicology testing capacity has increased 55 percent, while the area dedicated to its nonclinical testing services facilities now totals more than 100,000 square feet.

"The demand for testing has grown faster than the industry's ability to provide it," said VW Brinkerhoff, senior vice president and general manager at Gene Logic.

Quest Makes Equity Investment in Correlogic

Quest Diagnostics has made an equity investment in Correlogic Systems, the companies said last week.

The companies declined to disclose the amount of funding.

Quest retains an option to commercialize specific Correlogic diagnostics for particular disease states, the companies said. The company has also licensed Correlogic's OvaCheck for commercialization, the companies said.

OvaCheck was the subject of a February letter sent to Correlogic by Steve Gutman, director of the US Food and Drug Administration's Office of In Vitro Diagnostic Device Evaluation and Safety notifying the company that the diagnostic may be subject to the agency's premarket review requirements.

OvaCheck is now in validation testing, Correlogic said.

Correlogic is also developing a prostate cancer diagnostic with the Uniformed Services University of the Health Sciences and the Henry M. Jackson Foundation for the Advancement of Military Medicine based on the company's protein pattern-recognition approach, the company said in May.

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