By inking a deal to acquire two of Abbott’s diagnostics businesses for $8.13 billion in cash, General Electric has taken a major step in its goal to reposition its healthcare unit’s focus on an “early health model” that fuses in vitro and in vivo diagnostic technologies.
While the acquisition of Abbott’s in vitro diagnostics and point-of-care divisions will provide GE with one of the biggest diagnostic businesses in the world and an enormous sales force, the deal does not include Abbott’s molecular diagnostics unit. Neither GE nor Abbott would say whether the molecular diagnostics unit was for sale, and GE officials remain mum on the firm’s strategy for that fast-growing market.
The acquisition, which is expected to close during the first half of 2007, will immediately transform GE Healthcare from a firm with no in vitro diagnostics component to the world’s second-biggest in vitro diagnostics player behind Roche. It also will enable the company to more effectively compete with long-time rival Siemens, which recently completed its acquisition of Bayer Diagnostics for roughly $5.25 billion.
GE CEO Jeffrey Immelt says the purchase is “consistent with GE’s strategy” and that Abbott’s foothold in the “growing diagnostics field is aligned with our objective to deliver a comprehensive array of diagnostic products around the world.”
According to GE Healthcare officials, the unit had been eyeing the in vitro diagnostic space even before it acquired Amersham for more than $9 billion in 2004 -- a deal that provided GE Healthcare with a vast portfolio of imaging agents and marked its entry into the bioscience research field.
“We’ve been looking at this for five years,” said Joe Hogan, president and CEO of GE Healthcare, during the firm’s fourth-quarter conference call in January. “I feel strongly now with the integration [of Amersham] over the last three years [that] we had a much more solid platform to bring this on.”
- Edward Winnick
Harmony? PGx Draft Guidance Starts with Standards
A recently released draft guidance by the International Conference on Harmonization hopes that internationally standardized definitions of pertinent pharmacogenomic terms will help integrate the discipline into global drug development and approvals.
The guidance, called the E15 Terminology in Pharmacogenomics, was released in January. The US Food and Drug Administration will be accepting written or electronic comments on the draft guidance until April 9.
It “is the first step necessary to talking about pharmacogenomics on a global regulatory scale,” says Felix Frueh, associate director of genomics at the FDA. “Proper definitions will facilitate clear communication and create a foundation upon which we can build further activities, such as biomarker validation.”
The draft results from an ICH steering committee meeting last year, during which representatives from US, European, and Japanese regulatory agencies and industry organizations met for the first time to discuss pharmacogenomics.
The goal of that initial meeting was to eventually incorporate uniform pharmacogenomics terminology into drug discovery and development protocols.
Although harmonizing these terms will have regulatory impact, Frueh doesn’t expect the guidance to change the way business is done, or to squelch intellectual disagreements over the definitions.
According to the draft guidance, “the lack of consistently applied definitions to commonly used terminology raises the potential for conflicting use of terms.”
The draft guidance defines pharmacogenomics as “the investigation of variations of DNA and RNA characteristics as related to drug response.” Pharmacogenetics, “a subset of pharmacogenomics,” is defined as “the influence of variations in DNA sequence on drug response.”
According to Frueh, the terms were chosen based on what the ICH regions felt were the most important considerations for building the groundwork for future harmonization activities in this field.
- Turna Ray
Short Reads
US Genomics and Quest Diagnostics have signed a worldwide licensing agreement that gives Quest rights to develop a screening method for Fragile X syndrome. Quest will use US Genomics’ genetic testing applications to develop an automated test to enable “widespread population-based carrier testing” in the hopes of resolving the inadequacies of current screening methods.
BioServe joins a collaborative study with Harvard University and the University of Michigan designed to understand the link between lead exposure and childhood mental and behavioral development. Through the collaboration, Bioserve will purify and genotype tissue samples taken from 750 school children in India who have had exposure to lead pollutants.
The Vanderbilt-Ingram Cancer Center will use Affymetrix microarrays in translational research projects studying cancer and HIV and AIDS. Under the terms of the agreement, VICC and Vanderbilt University Medical Center will use Affy’s mitochondrial resequencing array as a tool to research genetic variants that may make patients more susceptible to adverse effects of certain drugs.
Oxford Gene Technology and the Wellcome Trust Sanger Institute will work together to develop a microarray to test for prenatal genetic defects. Under the agreement, OGT will use its inkjet in situ synthesis platform to make a 60-mer oligonucleotide microarray, while Sanger will contribute clinical knowledge.
Genome imaging company BioNanomatrix will work with the National Cancer Institute under a multi-year CRADA to develop technology to measure DNA damage caused by ionizing radiation therapy in cancer treatment.
Warnex Medical Laboratories will develop several new pharmacogenetic assays for Schering-Plough Canada’s clinical trials for cancer and infectious disease therapeutics.
BioImagene announced a collaboration with HP to bundle its high-content analysis and digital pathology platforms with HP servers. BioImagene says the integration of the technologies will allow for better management of the huge amounts of images and data generated in discovery, life sciences, and clinical laboratories.
Aruna Biomedical entered into a technology licensing agreement with the University of Georgia Research Foundation that will enable the company to commercialize human neural progenitor cell technology developed at the university. Through the deal, Aruna acquired an exclusive worldwide license to develop and commercialize neural cells derived from human embryonic stem cells.
Roche Pharma signed on to use the CNS subset of LifeSpan BioSciences’ DrugTarget Database, which contains information on more than 3,400 genes, 996 immunohistochemistry reports, and localization information for more than 450 potential drug targets.
Patents
US Patent 7,160,680. Mutation analysis by mass spectrometry using photolytically cleavable primers. Inventors: Markus Kostrzewa, Thomas Frohlich, Thomas Wenzel, Andres Jaschke, and Felix Hausch. Assignee: Bruker Saxonia Analytik. Issued: January 9, 2007.
This patent relates to “a method of a mass-spectrometric analysis of known mutation sites in the genome, such as single nucleotide polymorphisms (SNPs), using the method of restricted primer extension. The invention consists of the use of primers with a photocleavable linker,” according to the abstract.
US Patent 7,157,079. Combined tumor suppressor gene therapy and chemotherapy in the treatment of neoplasms. Inventors: Loretta Nielsen, Jo Ann Horowitz, Daniel Maneval, and William Demers. Assignee: Canji. Issued: January 2, 2007.
“This invention provides methods of treating mammalian cancer or hyperproliferative cells, said method comprising contacting said cells with a tumor suppressor protein or tumor suppressor nucleic acid and also contacting said cell with at least one adjunctive anti-cancer agent,” the abstract states.
US Patent 7,171,311. Methods of assigning treatment to breast cancer patients. Inventors: Hongyue Dai, Yudong He, Peter Linsley, Mao Mao, Christopher Roberts, Laura Van’t Veer, Marc Van de Vijver, Rene Bernards, and AAM Hart. Assignees: Rosetta Inpharmatics and Netherlands Cancer Institute. Issued: January 30, 2007.
The patent covers “sets of markers whose expression patterns can be used to differentiate clinical conditions associated with breast cancer, such as the presence or absence of the estrogen receptor ESR1, and BRCA1 and sporadic tumors, and to provide information on the likelihood of tumor distant metastases within five years of initial diagnosis.”
US Patent 7,171,030. Systems for analyzing microtissue arrays. Inventors: David Foran and Wenjin Chen. Assignee: University of Medicine & Dentistry of New Jersey. Issued: January 30, 2007.
“A tissue microarray imaging system autonomously images, analyzes, and stores data for samples in a tissue microarray … [and] may include a tissue microarray, a robotic microscope, and an imaging workstation that executes software to automatically control operation of the microscope to capture images from the microarray and analyze image results.”
Data Points
HR 493
Identifier for the Genetic Information Non-discrimination Act, a bill that has been stalled in the US Congress for 12 years. The bill has been unanimously approved by the US Senate twice, but has never come to a vote in the House of Representatives due to political opposition. Legislators are once again urging that it be passed.
2008
Celera says it still expects to reach profitability by 2008, though several relevant factors -- including pending clearance by the US FDA of its real-time HIV1 and hepatitis C viral load tests -- remain up in the air.