$100 million grant establishes institute at MIT and Harvard to support research in genomic medicine and disease processes
The Massachusetts Institute of Technology, Harvard University, and Whitehead Institute, all of Cambridge, Mass., have announced the joint creation of the Eli and Edythe L. Broad Institute dedicated to biomedical research and established with $100 million grant from the Los Angeles philanthropists for whom the Institute is named. According to a press release issued by the consortium, the Institute is being founded with the aim of realizing the promise of the human genome to revolutionize clinical medicine and to make knowledge broadly available to scientists around the world.

The Institute will begin operation in the Kendall Square area of Cambridge later this year. Its work represents a collaboration among MIT, Harvard and its affiliated hospitals, and the Whitehead Institute for Biomedical Research. Together, the institutions bring expertise in molecular biology, genomics, chemistry and chemical biology, computational science, and engineering, as well as breadth and depth in medicine.

The founding gift, expected to total $100 million over 10 years, is from the founder and chairman of SunAmerica and his wife. The Broad Institute, with MIT and Harvard working together, plans to raise up to $200 million in private support for its research programs over the next decade. In addition, there will be federal research support for work at The Broad Institute.

The Broad Institute’s mission will have two parts: to create comprehensive tools for genomic medicine and make them broadly available to scientists around the world; and, to pioneer applications of these tools to the study of disease, in order to propel the understanding, diagnosis, prevention, and treatment of disease. “Comprehensive tools for genomic medicine” refers to the complete set of information, laboratory reagents and analytical methods needed to study human biology and disease processes. This includes the ability to understand and monitor all genes and proteins in cells, tissues, and organisms, and to establish their role in disease; to understand human genetic variation and its association with susceptibility to disease; and to define the wiring diagram of cellular circuitry and its malfunction in disease.

In keeping with the tradition of the international Human Genome Project, The Broad Institute plans to collaborate closely with other efforts to produce such tools. The applications to disease will include using the tools to understand the molecular basis of broad aspects of medicine, such as cancer; metabolic disorders, including diabetes, obesity and heart disease; and inflammatory and infectious diseases. Work will range from research on basic models related to disease mechanisms to the collection and molecular analysis of clinical materials, employing the toolkit for genomic medicine to take global views of biological systems.

Biosite and Beckman Coulter sign BNP test agreement
Biosite Incorporated of San Diego, Calif. and Beckman Coulter, Inc. of Fullerton, Calif. have signed an agreement for Beckman Coulter to manufacture and Biosite to commercialize a b-type natriuretic peptide (BNP) test for use on Beckman Coulter’s immunoassay systems. Expected to be available in the first quarter of 2004, the BNP test will be sold worldwide through a combination of Biosite’s direct and distributor sales forces.

Designed to correlate to the existing rapid Triage BNP Test run on Biosite’s Triage MeterPlus testing platform, the BNP test will be available for use on Beckman Coulter systems including the Access and Access 2 immunoassay systems, Synchron LXi 725 chemistry and immunoassay workstation, and the new high-throughput UniCel DxI 800 Access immunoassay system.

“Combining Biosite’s successful point-of-care test for BNP with Beckman Coulter’s automated testing capability gives health services providers a fully correlated set of results,” said Kim Blickenstaff, Biosite president and chief executive officer.

Under the terms of the agreement, Beckman Coulter will manufacture BNP test reagents for use on Beckman Coulter’s immunoassay systems. Biosite will retain sole control of promotion, pricing, sales and support for the new test, while Beckman Coulter will retain responsibility for placing and supporting their immunoassay systems.

Biosite’s Triage BNP Test is currently used in more than 1,700 U.S. hospitals and in more than 50 international markets. To date, the test has been available solely on Biosite’s Triage MeterPlus testing platform, which enables rapid testing with results in approximately 15 minutes. The diagnostic has received FDA clearance as an aid in the diagnosis of congestive heart failure, an aid in the assessment of disease severity and an aid in the risk stratification of patients with acute coronary syndromes, a group of sudden and severe clinical symptoms suggesting a lack of blood flow to the heart.

McDonald’s asks meat suppliers to begin antibiotics phase out
McDonald’s Corporation of Oak Brook, Ill. has announced plans that call for its suppliers worldwide to phase-out of animal growth promotion antibiotics that are used in human medicine. The company expects to eliminate the use of some antibiotics that promote growth in healthy animals and to significantly reduce the use of other antibiotics that protect animals against disease. The change, outlined in the company’s “Global Policy on Antibiotics” is prompted by increasing evidence that overuse of antibiotics in animal agriculture creates antibiotic resistance in animals and in the bacteria that cause disease in humans.

In making the decision the company anticipates that its purchasing power can be leveraged to help reverse the trend of antibiotics overuse in animal agriculture around the world. McDonald’s is the world’s largest restaurant chain, and one of the world’s biggest purchasers of meat. McDonalds purchases over 2.5 billion pounds of chicken, beef and pork annually.

 NCI and FDA announce a joint program to streamline the development of cancer drugs and biomarkers
Under an agreement between the Food and Drug Administration (FDA) and the National Cancer Institute (NCI), which is part of the National Institutes of Health (NIH), the two agencies will share knowledge and resources to facilitate the development of new cancer drugs and speed their delivery to patients.

FDA Commissioner Mark McClellan, M.D., Ph.D., and NCI Director Andrew von Eschenbach, M.D., said that they will establish a multi-part Interagency Agreement to enhance the efficiency of clinical research and the scientific evaluation of new cancer medications.

“The collaboration will help the two agencies take full advantage of their combined knowledge base at a time when many new kinds of anti-cancer agents are in the pipeline,” said von Eschenbach. “Molecularly targeted drugs and other novel agents offer great promise, but they also present new challenges that require more collaboration between those involved in their discovery and development,” he said.

An NCI/FDA Oncology Task Force, which involves senior staff from both agencies, will oversee implementation of the specific components of the agreement. Areas of collaboration include the following developing markers of clinical benefit (biomarkers) for evaluating new cancer medicines. The two agencies will work to develop a standard approach for evaluating biomarkers that demonstrate a drug’s clinical effectiveness and that can potentially serve in clinical trials as surrogate endpoints, which are substitutes for more conventional measures, such as survival time or mortality. Better defined surrogate endpoints could help speed the development of new drugs.

The agreement also calls for creation of a cancer bioinformatics infrastructure to improve data collection, integration, and analysis for preclinical, preapproval, and post-approval research across all of the sectors involved in the development and delivery of cancer therapies.

NCI and FDA staff will continue their current collaboration on clinical proteomics (involving the discovery of protein markers in the blood that can be used to detect and monitor disease course and drug response) as a possible model for initiatives in areas such as diagnostic imaging and molecular targeting.

“This is truly a unique opportunity to improve the development process for new cancer drugs and diagnostics,” said Anna Barker, Ph.D., NCI’s deputy director for strategic scientific initiatives, and co-chair of the NCI/FDA task force. “Whether you’re in academia or industry or government, bridging the gaps between research and regulatory processes will benefit everyone involved, especially cancer patients.”

GE Medical Systems to acquire Triple G Systems
GE Medical Systems Information Technologies, the healthcare IT business of General Electric Company in Milwaukee, Wisc.,and Triple G Systems Group, Inc. of Toronto, Ontario have signed a definitive transaction agreement, pursuant to which GE will acquire Triple G. In this transaction, GE will acquire all of the issued and outstanding common stock of Triple G for a consideration of $3.30 (Canadian) per share, payable in cash.

“Laboratory information systems are critical to delivering quality patient care in today’s healthcare environment,” said Dow Wilson, president and CEO of GE Medical Systems Information Technologies. “The increased focus on raising

clinical productivity, while improving the quality of patient care has made clinicians eager for technology that provides real-time patient information across the healthcare enterprise. Because most clinical treatment decisions are based on laboratory test results, the potential for improving patient safety by enhancing workflow in this area is significant,” added Wilson.

According to Wilson, the combination of Triple G’s laboratory information technologies with GE’s advanced clinical information systems and IT implementation experience, will provide clinicians with a comprehensive end-to-end clinical information system spanning all care areas.

The transaction, which is subject to the requisite Triple G shareholder and regulatory approvals, and other customary conditions, is expected to close in the third quarter of 2003.

Scientists find protein that controls prostate cancer’s spread
A team from the University of Michigan Comprehensive Cancer Center has published a report in the June 18, 2003 issue of the Journal of the National Cancer Institute that may provide insight into why some men’s prostate cancer metastasizes and becomes deadly, while other men’s prostate cancer stays contained. The team reports strong evidence that a protein called RKIP, for Raf kinase inhibitor protein, governs the ability of prostate cancer cells to leave their original location and enter nearby blood vessels in a process called vascular invasion. Once in the blood vessels, the cells can be transported to other parts of the body in a cascade of events that leads to metastatic cancer.

According to the new report, tumors that produce a normal amount of RKIP appear unable to make the jump to the vascular system, while tumor cells lacking the inhibitor protein can get into the bloodstream. “The gene encoding RKIP appears to be a novel metastasis suppressor gene, involved in blocking the cell-signaling processes that allow cancer cells to enter the bloodstream,” says senior author Evan Keller, DVM, Ph.D., an associate professor of Comparative Medicine and Pathology at the U-M Medical School. “If there is RKIP expression in a tumor, this first important step appears to be less likely.”

Part of this new discovery was made using tissue samples from patients treated for metastatic prostate cancer at the U-M Cancer Center, so researchers believe the laboratory findings are especially relevant to “real life” cases of cancer.

RKIP could also be involved in other forms of cancer. “Understanding the basic biology means we may eventually be able to help patients with any form of disease that depends on RKIP to keep metastasis from happening,” said Keller in a press release.

 OraQuick Rapid HIV-1 Antibody Test receives gold Medical Design Excellence Award
OraSure Technologies, Inc. of Bethlehem, Penn. has been awarded the gold Medical Design Excellence Award in the “In Vitro Diagnostics” category for its OraQuick Rapid HIV-1 Antibody Test. OraSure received FDA approval of the OraQuick test on November 7, 2002 and a CLIA waiver on January 31, 2003.

The MDEA competition exclusively recognizes design advances for medical products. The products are evaluated by a multidisciplinary panel of third party jurors using several criteria including: design and engineering attributes, user-related features that improve healthcare delivery and change traditional medical attitudes or practices, enhanced benefits to the patient, and the ability of the product development team to overcome design and engineering challenges to meet clinical objectives. The impartial panel is comprised of individuals with expertise in biomedical engineering, human factors, industrial design, medicine, and diagnostics.

The silver medal went to the Accu-Chek Inform blood glucose meter manufactured by Roche Diagnostics of Indiannapolis, Ind.

 Roche launches pharmacogenomic microarray powered by Affymetrix technology
Roche Diagnostics of Basel, Switzerland has announced the launch of the AmpliChip CYP450 microarray in the U.S., the company’s first microarray for clinical applications. The product enables clinical diagnostic laboratories to identify polymorphisms in two genes, the CYP2D6 and CYP2C19, which play a major role in drug metabolism. According to the company, which expects the AmpliChip CYP 450 to generate over $100 million by 2008, these polymorphisms in consideration with other contributing factors can help a physician select the best drug and set the right dose for a patient sooner, as well as avoid drugs that may cause the patient to suffer serious adverse reactions.

A significant percentage of people fail to benefit from many drugs currently on the market, and many suffer from adverse drug-related events. The Amplichip CYP is a diagnostic quality tool that offers the potential to address the problems. In the U.S. alone, serious adverse drug reactions cause an estimated 100,000 deaths each year and are the fifth leading cause of death. Other less serious adverse drug reactions are estimated to affect more than 2 million people in the U.S. annually.

Roche developed the AmpliChip CYP450 microarray on the Affymetrix microarray platform. In January 2003, Roche and Affymetrix signed an agreement that gives Roche non-exclusive rights to develop human diagnostic products using core Affymetrix technologies. As part of the agreement, Affymetrix will manufacturer Roche’s AmpliChip microarrays. Roche will sell the AmpliChip CYP450 microarray initially as an analyte specific reagent (ASR). Roche expects the test to be available as an in vitro diagnostic test in the U.S. later in 2004.

Roche plans to develop additional microarray-based diagnostic tools in the areas of HIV-1 resistance genotyping, p53 cancer resequencing, colorectal cancer risk prediction, cystic fibrosis, and human papilloma virus (HPV) genotyping. It is anticipated that these microarrays will provide information about relevant aspect of an individual’s genetic make-up or reveal distinguishing characteristics of the disease or infectious agent itself that can influence choice and duration of therapy. Roche expects these new AmpliChip products to be available by the end of 2004.