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Eppendorf and Bio-Rad, Waters and Lambda Therapeutics, PerkinElmer, Thermo Fisher Scientific and Microsoft, Sigma-Aldrich and Ingenuity, Celera and Merck, and FDA

Eppendorf Files Countersuit Against Bio-Rad
Eppendorf North America, the Westbury, NY-based unit of German firm Eppendorf, has filed a countersuit against Bio-Rad Laboratories in the US District Court for the Northern District of California.
The suit is in response to Bio-Rad’s July suit filed in a US District Court in Texas alleging that Eppendorf North America is infringing Bio-Rad’s US Patent No. 6,340,589, which covers the firm’s thin-well microplate (see BioCommerce Week 7/11/2007).
The firms had been in negotiations to settle their dispute out of court when Bio-Rad filed the complaint in Texas, according to court documents filed by Eppendorf.
Eppendorf has now sued Bio-Rad asking the California court to declare that it is not infringing the patent, that Bio-Rad’s patent is invalid, and that the patent is unenforceable. Among Eppendorf’s claims is that “those involved in the prosecution of the ‘589 patent were aware of material prior art, which they failed to disclose to the United States Patent Office.”
In addition, Eppendorf argues that the Eastern District of Texas is not a proper venue for Bio-Rad’s case and said that it wants the case in Texas dismissed or moved to the Northern California court.
Eppendorf is the third company Bio-Rad has sued this year over the ‘589 patent, which covers the plate and methods for manufacturing the product. Earlier this year, it sued 4titude Ltd. and Phenix Research Products alleging that those firms infringed the same patent.

Waters Inks Pact With Indian CRO
Waters will provide mass spectrometry equipment and training to the clinical research services company Lambda Therapeutics Research when Lambda lands service contracts, a Waters spokesman told BioCommerce Week sister publication GenomeWeb Daily News this week.
The agreement “paves the way” for Ahmedabad, India-based Lambda to purchase Waters’ Quattro Premier XE tandem quadrupole mass spectrometer, Acquity UPLC system, and MassLynx software for use in analyzing complex biological samples, Waters spokesman Jeff Tarmy said.
“The agreement enables Lambda to meet its international business goals by fulfilling its needs for innovative laboratory equipment, including mass spectrometry, liquid chromatography, and laboratory software solutions,” the company said in a statement.
Tarmy said the plan means that “the agreements are in place” for Lambda to buy the tools, training, and knowledge, and that a pathway has been set for Lambda to handle orders as they come in.
Lambda works as a clinical research services partner with pharmaceutical companies, and has facilities in Mumbai, Chennai, and in Warsaw, Poland.
Financial terms of the agreement were not released.

PerkinElmer to Supply Saudi Hospital With Newborn Screening Tools
PerkinElmer has struck a multi-year agreement with a hospital in Riyadh, Saudi Arabia, to provide tools, materials, and expertise for newborn screening services.
Through the agreement, PerkinElmer will provide the King Faisal Specialist Hospital and Research Center with reagents, software, and screening know-how that the company said will double the hospital’s screening capacity by the end of 2008.
The company said the hospital hopes to increase its screening rate to as many as 200,000 newborns by the end of 2008 and as many as 400,000 by the end of 2009. The company’s regional distributor, HVD Vertriebs, will execute the contract, under which the hospital will use the company’s Specimen Gate screening lab information-management system software.
The hospital currently uses PerkinElmer reagents to screen for congenital hypothyroidism, but this agreement will enable it to screen for three additional illnesses, including congenital adrenal hyperplasia, which affects adrenal glands; galactosemia, which can cause poor development or death; and biotinidase deficiency, which can cause seizures, developmental delay, and eczema and hearing loss.
Financial terms of the agreement were not released.

Thermo Fisher, Microsoft Collaborate on Web-Enabled LIMS
Thermo Fisher Scientific and Microsoft have penned a partnership to "web-enable" Thermo’s lab information-management system products with the goal of streamlining and simplifying how customers implement and manage the software, Thermo said last week.
Thermo Fisher said it will use Microsoft’s ClickOnce technology to update its LIMS solution, which will combine the functionality of a desktop product with the centralized structure of a web-enabled LIMS.
Unlike most LIMS, which are based on a client-server model, a web-enabled LIMS only needs to be installed once on a central server, and then a URL is sent to users that allows them to run the application in a "sandbox" on their desktops, Thermo said.
According to the company, this approach minimizes the risk of application conflicts that are often associated with client installations and also reduces the amount of time and resources IT departments need to install and maintain the LIMS infrastructure.

Sigma-Aldrich, Ingenuity to Co-Develop Portfolio Search Function
Ingenuity Systems and Sigma-Aldrich plan to co-develop a tailored search capability based on Ingenuity’s database of biological networks with the aim of expanding Sigma customers’ web-based shopping options, Sigma said last week.
Specifically, the deal calls for Sigma-Aldrich to “leverage Ingenuity's knowledge base and integrate its search technology into Sigma-Aldrich's life science product portfolio,” Sigma said
Ingenuity’s database is developed from “millions of expert curated relationships among proteins, genes, complexes, cells, tissues, drugs and diseases,” Sigma said.
Sigma said the new search capability will be freely available to researchers and will allow them to locate Sigma-Aldrich products that are relevant to their research and to understand these products "in a content-rich environment of highly relevant biological and chemical relationships.”
Sigma said the tool will extend its current search capability, which allows customers to match gene information to thousands of its products, “to much broader biological queries around disease, function, and pathways.”
Ingenuity CEO Jake Leschly said Sigma’s interest in expanding its web-based search options reflects an “increasing emphasis on a systems view of biology” that requires scientists to design experiments based on a more complete and dynamic understanding of biology.
Financial terms of the agreement were not released.

Celera to Develop Companion Molecular Dx for Merck Cancer Drugs
Celera this week said that it will collaborate with Merck & Co. to develop molecular diagnostics for the drug maker to use in its clinical trials, which could potentially be used as companion diagnostics for Merck’s cancer drugs.
Terms of the deal, which is expected to wrap up at the end of Celera’s fiscal year 2008, call for the Applera unit to create assays based on gene-expression profiles that Merck identifies.
Celera said it will collect an undisclosed payment for its work in the collaboration, and will receive another payment if Merck opts to transfer one of Celera’s validated tests to a clinical reference lab.

FDA Seeks More Comments on IVDMIA Guidance
Molecular diagnostics researchers who were unable to have their opinions heard about the US Food and Drug Administration plan to oversee in vitro multivariate diagnostics now have until Oct. 17 to make themselves heard.
The FDA this week announced that it has reopened the comment period for the "Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Multivariate Index Assays." The draft is a revised version of an original draft guidance the FDA published in September of 2006.
In that draft guidance, the FDA defined IVDMIAs as tests that use mathematical formulas to interpret gene and protein data to guide medical decision-making. The FDA said such tests, ordinarily overseen by CLIA regulations, must instead be cleared by the agency due to their complexity.
But in February, representatives from the healthcare and pharmacogenomics communities challenged the guidance by claiming the FDA does not have the right to regulate IVDMIAs, and that the agency's draft represents an antiquated view of a field that is constantly advancing. 
At the time, Steve Gutman, FDA's director of the Office of In Vitro Diagnostic Device Evaluation, responding by saying that the FDA "always expected that the document was not perfect and I guess you have suggested the same."
The FDA said this week that the recent draft, published in July, "simplified the definition of IVDMIAs and provided a variety of specific examples to assist sponsors in understanding the definition."

The Scan

Genome Sequences Reveal Range Mutations in Induced Pluripotent Stem Cells

Researchers in Nature Genetics detect somatic mutation variation across iPSCs generated from blood or skin fibroblast cell sources, along with selection for BCOR gene mutations.

Researchers Reprogram Plant Roots With Synthetic Genetic Circuit Strategy

Root gene expression was altered with the help of genetic circuits built around a series of synthetic transcriptional regulators in the Nicotiana benthamiana plant in a Science paper.

Infectious Disease Tracking Study Compares Genome Sequencing Approaches

Researchers in BMC Genomics see advantages for capture-based Illumina sequencing and amplicon-based sequencing on the Nanopore instrument, depending on the situation or samples available.

LINE-1 Linked to Premature Aging Conditions

Researchers report in Science Translational Medicine that the accumulation of LINE-1 RNA contributes to premature aging conditions and that symptoms can be improved by targeting them.