Affymetrix’s CSL, DOCRO Ink IVD Alliance
Affymetrix’s Clinical Services Laboratory and in vitro diagnostics contract research company DOCRO have formed a partnership to help pharmaceutical companies, IVD makers, and other customers move their products toward clearance by the US Food and Drug Administration, Affymetrix said this week.
Affy said the agreement offers its ACSL customers validation and clinical trial services such as protocol design, patient recruitment, clinical site training and monitoring, sample procurement, device testing, and guidance for the submission process.
Affy said DOCRO will supply its ACSL customers “a clear path and understanding of how to commercialize IVD products.”
Affymetrix, CRI to ID Genetic Variations Tied to Childhood Diseases
Affymetrix and the Children’s Research Institute in Wisconsin will use Affy’s GeneChip technology to identify genetic variations linked to common, complex childhood diseases, Affy said this week.
CRI, a non-profit medical research arm of the Children's Hospital and Health System affiliated with the Medical College of Wisconsin, intends to use the data from the large-scale studies to develop diagnostics, and to “show the clinical utility of array-based molecular diagnostics,” Affy said.
Affy is conducting the five-year partnership through its Translational Medicine Program.
Third Wave to Collaborate With LabCorp on Cardio Companion Dx
Third Wave Technologies said this week that it will collaborate with Laboratory Corporation of America to develop a diagnostic that may be used in conjunction with a heart failure drug that is being developed by Arca Discovery.
The diagnostic is intended to help physicians determine use of the drug bucindolol, a beta blocker that Third Wave said could be "the first genetically targeted cardiovascular drug."
The test will be developed in tandem with the drug's approval process, the company added.
Bucindolol has shown "extensive" efficacy and safety in Phase III trials, Third Wave said, noting that Arca plans to use genetic data to target patients most likely to respond to the drug when it seeks FDA approval in 2008.
Labcorp acquired the rights to develop and commercialize the companion diagnostic for the Arca drug in February.
Financial terms of the agreement were not released.
Bio-Rad to Pay Ciphergen $2M for Re-Issued SELDI Patent, Inks Dx Deal With Quest
Bio-Rad Laboratories will pay Ciphergen $2 million once the US Patent and Trademark Office re-issues a SELDI mass-spectrometry-related patent, Ciphergen said last week.
Ciphergen said the USPTO has given it a notice of intent to issue a Re-examination Certificate for the patent, entitled “Method and apparatus for desorption and ionization of analytes” and assigned to the Baylor College of Medicine.
Ciphergen said the payment is part of Bio-Rad’s acquisition of Ciphergen’s proteomic tools business last year.
In separate news announced this week, Bio-Rad said that it signed two multi-year agreements with Quest Diagnostics, which will place Bio-Rad’s BioPlex 2200 systems, autoimmune test reagents, and HIV-1/HIV-2 PLUS O EIA assay at its reference labs throughout the US.
The firms did not disclose financial terms of the agreement.
Antitrust Waiting Period Expires for Qiagen, Digene Merger
Qiagen said this week that the antitrust waiting period required by the Hart-Scott-Rodino Antitrust Improvements Act of 1976 has expired with respect to its intended merger with Digene.
The expiration of the waiting period satisfies one of the key conditions required to close the transaction.
Qiagen announced in early June that it would merge with Digene in a deal valued at roughly $1.6 billion (see BioCommerce Week 6/6/6007). The deal is expected to close in August or September.
Invitrogen to Sell Biocon’s Pharma-Grade Insulin to Cell-Culture Market
Invitrogen will exclusively market pharmaceutical-grade insulin made by Indian biotech Biocon to global cell-culture customers, Invitrogen said this week.
Invitrogen said Biocon’s insulin is equivalent to others used for cell-culture bio-manufacturing and in delaying apoptosis in mammalian cell cultures.
This agreement will enable the companies to offer scientists “a competitive alternative” to other human insulin suppliers, who offer a pharmaceutical-grade product only in bulk, said Jeff Greenberg, Invitrogen’s vice president of Bioproduction. Invitrogen will market Biocon’s insulin in volumes of 25 kg or more.
Financial terms of the agreement were not released.
Roche Sells Three 454 Sequencers, Signs Cross-Marketing Pact with Eppendorf
Roche has recently sold three of its 454 GS FLX sequencers to research and service organizations in Bloomington, Ind., Liverpool, UK; and Munich, Germany, according to Roche and the customers.
The University of Liverpool, Indiana University, and the German companies MWG Biotech and Eurofins Medigenomix all are stocking their labs with the next-generation sequencers.
Indiana’s Center for Genomics and Bioinformatics is buying a GS FLX sequencer from Roche for de novo genome sequencing, genotyping, cDNA sequencing, and microRNA sequencing, the CGB said last week.
The CGB, located at Indiana University Bloomington, said it paid around $500,000 for the sequencer, which it expects to install in mid-July.
The IU center used a grant from the Indiana MetaCyt Initiative, which also pays for maintenance and operational costs, CGB said.
The University of Liverpool, meantime, has installed a FLX in its School of Biological Sciences, making it one of only two UK universities with the new sequencer.
The school said its researchers will use the tool for projects studying marine DNA, illnesses that pass between domestic pets and humans, among other studies. Financial terms of the placement were not released.
Finally, MWG Biotech and Eurofins Medigenomix upgraded to the FLX system. Last November they became the first sequencing providers in Germany to offer services on the 454 GS 20 system, the predecessor to the GS FLX.
Financial terms of the placements were not released.
Roche separately announced this week that it and German lab equipment provider Eppendorf plan to co-market some of their products to researchers performing protein-expression projects.
Under the agreement, the companies will market Roche Applied Science’s Rapid Translation System reagents portfolio with Eppendorf’s Thermomixer system as a replacement for Roche’s RTS Proteomaster.
“The characteristics of the Thermomixer comfort will be the ideal complement for our reagents for protein expression,” Manfred Baier, head of Roche Applied Science, said in a statement.