American Association for Clinical Chemistry
Better health through laboratory medicine
August 2009 Clinical Laboratory News: Industry Profiles

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August 2009: Volume 35, Number 8

Fox Chase Starts Personalized Medicine Institute

In May, the Fox Chase Cancer Center in Philadelphia launched the Institute for Personalized Medicine with the goal of matching emerging targeted drug therapies to the genetic profiles of individual patient tumors. Initially, Fox Chase will sequence the tumors of patients for a number of known cancer-related genes. The genetic information will then be used to select the most appropriate treatment regimen in a phase 1 study designed to test novel cancer therapeutics in patients with advanced cancer. The Institute for Personalized Medicine will build on Fox Chase’s Biosample Repository and Tumor Bank to add more knowledge about the genetic information in patient tumors. “With information from this program, we should eventually be able to choose a drug or set of drugs that will be optimally effective for that patient based on molecular analysis of an individual patient’s tumor,” said George Simon, MD, Fox Chase’s director of thoracic oncology. “We will be able to offer doctors more effective, personally tailored treatment options for their patients.”

Illumina to Offer Personal Genome Sequencing Service

Illumina has partnered with a number of direct-to-consumer genomics firms—including 23andMe, Knome, Navigenics, and Decode Genetics—to deliver the first personalized, whole genome sequencing analysis for under $50,000. The service will offer sequencing of an individual’s DNA and information on SNP variations and other characteristics of the genome. Illumina’s partners will provide secondary analysis such as disease risk, ancestry, and information on other traits of interest. “Rapidly decreasing costs have made sequencing a pervasive technology that can begin to be accessed at the consumer level,” said Jay Flatley, CEO and president of Illumina. “We are entering a new era of genomic health, where information from an individual’s genome will begin to inform lifestyle decisions and ultimately assist in health management. We believe that in the long-run personal genome sequencing will become a routine practice and the information generated will enable physicians to make better healthcare decisions for the consumer.”

Exact Sciences Licenses Mayo Tests

Exact Sciences announced that it has entered into a collaboration and license agreement with Mayo Clinic focused on developing diagnostics for colorectal cancer. Under the agreement, Exact Sciences has secured rights to intellectual property developed by David Ahlquist, MD, gastroenterologist, of the Mayo Clinic in exchange for up-front, milestone and royalty payments to Mayo and funding for future work in Ahlquist’s lab. Exact Sciences will retain exclusive rights to commercialize breakthroughs that result from this collaboration. The licensed patents cover advances in sample processing, analytical testing, and data analysis associated with non-invasive, stool-based DNA screening for colorectal cancer.

Boston Hospital to Collect Patients’ Genomic Data

Boston’s Brigham and Women’s Hospital announced plans to collect blood samples for genetic analysis from all consenting patients, which will allow scientists to analyze patient’s genomes alongside detailed medical histories. The hospital currently houses one of the most sophisticated electronic medical record systems in the country, containing large amounts of patient information that is missing from most large-scale genetic studies. The project could also serve as a model for how to integrate electronic medical records and clinical care. Researchers hope to expand the project to include the entire Partner’s Healthcare System, a local network of hospitals and medical centers that treats hundreds of thousands of patients.

UCSF, Abbott Partner on Pathogen Diagnostics Lab

The University of California, San Francisco (UCSF), and Abbott have partnered to launch a new research center aimed at developing diagnostic technologies for identifying viruses based on their DNA profiles. The UCSF Viral Diagnostics and Discovery Center will use sequencing, microarrays, and other genomic technologies to characterize pathogens linked to acute and chronic human illnesses. Two of the lab’s first projects will be analyzing strains of H1N1 influenza and strains of HIV from Cameroon. The center will be unique in offering both viral discovery and diagnostic resources for clinical researchers and physicians. Abbott has been working with UCSF to create the center for the past 2 years, and the center will help Abbott develop diagnostic technologies and tests for new infectious agents and tools for screening blood supplies. Financial details of the partnership were not disclosed.

SEC Investigating Sequenom over Down Syndrome Test

Sequenom disclosed in a filing with the U.S. Securities and Exchange Commission (SEC) that the SEC is investigating the firm regarding the mishandling of test data and results for its SEQureDx Down syndrome test. The filing does not mention the reasons behind the SEC’s investigation, but Sequenom states that it intends to “cooperate fully with the SEC in this matter” and that Sequenom’s “internal investigation is ongoing.” Sequenom announced in late April that mishandling of test data would delay the release of the test until later this year, and that a special committee of independent directors had been formed to oversee an investigation into employees’ activity related to the mishandled results.

Indiana University Licenses Breast Cancer Biomarker to Clarient

Indiana University (IU) has granted an exclusive intellectual property license to Clarient to commercialize a pharmacogenomic assay that detects a breast cancer biomarker discovered by researchers at IU. Patients who test positive for biomarker FOXA1, also known as forkhead box A1, are more likely to respond to anti-estrogen hormone therapies such as tamoxifen. Studies indicate that those who tested positive for the presence of FOXA1 had less aggressive cancer. Clarient CEO Ron Andrews also noted that FOXA1 has been shown to predict risk of cancer recurrence in estrogen receptor-positive, node-negative breast cancer patients. “FOXA1 has demonstrated an ability to differentiate between unique sets of breast cancer characteristics,” said Ken Bloom, MD, Clarient’s chief medical officer. Terms of the licensing deal were not disclosed.

St. Joseph’s Hospital to Offer Castle Biosciences Test

St. Joseph’s Hospital and Medical Center of Phoenix, Ariz., will offer a pharmacogenetic test for a brain cancer drug manufactured by Castle Biosciences. Under the partnership, the St. Joseph’s DNA Diagnostics Lab will perform Castle Biosciences’ DecisionDx-GBM test to determine if patients will be sensitive or resistant to standard first-line treatments for glioblastoma multiforme tumors. “Our offering this test is a prime example of translational genomics closing the loop between the research lab and the clinic,” said John Stone, PhD, laboratory director of St. Joseph’s DNA Diagnostics Lab. “While there is currently no cure, this test can certainly help patients understand and plan for the likely course of the disease.” St. Joseph’s is currently the only lab to offer the test.