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Proteome Systems, Egenix, Sentigen, FDA, Applied Imaging, Genetix, Pfizer, PerkinElmer

Proteome Systems, Egenix Find Prostate Cancer Biomarker, Developing Test
Researchers at Proteome Systems and Egenix have identified a prostate cancer biomarker associated with human carcinoma antigen (HCA), Proteome Systems said this week.
The two companies are collaborating on a non-invasive prostate cancer diagnostic test to detect the presence of the prostate-specific glycoprotein and HCA.
HCA, which is over-expressed in prostate cancer tissue, was discovered by researchers at Harvard Medical School and licensed by Egenix as a biomarker for several types of cancers including prostate, lung, breast, and ovarian cancer.

Proposed Merger with Sentigen Would Give Invitrogen Protein-Protein Interaction Measurement Tool 
Invitrogen has agreed to purchase Sentigen in a cash transaction worth about $25.9 million, the companies announced late last week. 
Under the terms of the deal, Invitrogen will pay $3.37 for each issued and outstanding share of Sentigen stock. The price represents a premium of 35 percent over the average closing price of Sentigen’s common stock for the 30-business-day period prior to the execution of the merger agreement, the companies said. 
As of June 30, Sentigen had cash and cash investments of $11.7 million and debt of $800,000. 
In a press release, Invitrogen said Sentigen’s proprietary Tango assay system and division-arrested Assay Ready Cells “will bolster [its] leading position in assay development by providing a novel approach to screen G-protein coupled receptors.” 
In addition to providing a universal assay system for GPCR targets, the most screened target class in drug discovery, Invitrogen said the Tango assay system is useful in measuring protein-protein interactions in living cells, “which can be an important way to determine the function of a protein of interest.” 
Sentigen is based in Phillipsburg, NJ. 
The deal is expected to close during the fourth quarter and is not expected to have a material effect on Invitrogen’s financials for fiscal 2006 or decelerate the progress of its share repurchase program announced last month, the company said.

FDA Issues Draft Guidance on Multivariate Index IVDs
The US Food & Drug Administration this week released a draft regulatory guidance for industry and clinical labs for in vitro diagnostic multivariate index assays.
IVDMIAs use mathematical formulas to interpret gene and protein data to guide medical decision-making.
The guidance, available here, outlines the agency’s regulatory approach to IVDMIAs to assure the public that these tests are safe and effective. The draft guidance is intended for public comment and does not establish legally enforceable responsibilities at this time.
The draft defines IVDMIAs and outlines the regulatory rules for companies and labs that manufacture them.
IVDMIAs employ an algorithm to evaluate patient test results, including protein and genetic data, along with other clinical information for diagnosis and treatment for diseases such as breast cancer, prostate cancer recurrence, cardiovascular disease, and Alzheimer's disease.
The FDA is accepting public comment on the draft guidance for 90 days.

Applied Imaging, Genetix Agree to $18.3M Merger 
Applied Imaging announced late last week that it will be acquired by Genetix Group in an all-cash transaction worth $18.3 million. 
The deal, expected to close during the fourth quarter, calls for Genetix to pay $3.03 for each share of Applied Imaging’s common stock.
Genetix, based in New Milton, UK, designs and develops instruments and consumables used in the analysis and selection of cells for the production of therapeutic proteins.  
“By diversifying our product portfolio and building our US presence, we will be better able to address global growth opportunities in the drug discovery and clinical diagnostics markets,” said Mark Reid, CEO of Genetix, in a statement.

Pfizer Builds on Deal to Use Odyssey PCA Tool
Pfizer will use Odyssey Thera’s Protein-fragment Complementation Assay technology to evaluate the selectivity of potential Pfizer drugs, Odyssey announced this week. 
The deal builds upon an agreement reached between the two companies in 2005 and will focus on Pfizer’s chemical leads and drug candidates for several therapeutic areas, Odyssey said. 
Odyssey will receive an upfront payment, research and expenditure funding and payments based on successful milestones being reached. 
No further financial details of the deal were disclosed. 
Odyssey’s PCA technology measures pathway activity within living cells and can be applied to signalling pathways.

PerkinElmer Buys Avalon, Adding Raman Spectrometers
PerkinElmer announced this week it acquired Avalon Instruments Limited, adding a family of benchtop dispersive Raman Perkin Elmer’s molecular spectroscopy product portfolio.
Raman spectroscopy “identifies and characterizes the composition of both organic and inorganic materials in a wide range of applications,” the company said in a statement, adding that the Avalon Raman product line supports “both bulk analysis and microscopic imaging.”
Financial terms of the transaction were not disclosed.

The Scan

Pig Organ Transplants Considered

The Wall Street Journal reports that the US Food and Drug Administration may soon allow clinical trials that involve transplanting pig organs into humans.

'Poo-Bank' Proposal

Harvard Medical School researchers suggest people should bank stool samples when they are young to transplant when they later develop age-related diseases.

Spurred to Develop Again

New Scientist reports that researchers may have uncovered why about 60 percent of in vitro fertilization embryos stop developing.

Science Papers Examine Breast Milk Cell Populations, Cerebral Cortex Cellular Diversity, Micronesia Population History

In Science this week: unique cell populations found within breast milk, 100 transcriptionally distinct cell populations uncovered in the cerebral cortex, and more.