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Affy to Launch Clinical Lab Business in 2007, Breaks Ground on New Manufacturing Plant

Affymetrix will open a clinical lab business next year with an eye toward growing its molecular diagnostics business, CEO Stephen Fodor said this week at the JPMorgan Healthcare Conference, held in San Francisco this week.

Affymetrix Clinical Laboratories will be based in Sacramento, Calif., and will develop CLIA-certified tests for diagnostic partners based on the firm's GeneChip technology. Fodor said the tests would enable partners to get their assays on the market quicker than developing tests that have to be cleared by the US Food and Drug Administration's 510(k) process.

In addition to the clinical lab business, Fodor said Affymetrix has broken ground on a new microarray and reagent-manufacturing facility in Sacramento that is expected to open in 2007.

The firm had some problems with manufacturing capacity during 2005, which partially contributed to a shortfall in fourth-quarter and full-year revenue. In response to those difficulties, Affymetrix expanded its capacity 30 percent during the fourth quarter of 2005, and company officials said the firm would expand manufacturing capacity an additional 30 percent during the first quarter of 2006.

Affymetrix officials also noted at the conference that the firm is leasing a manufacturing facility in Singapore to make instrumentation and they expect to begin manufacturing there in the second half of 2006. The facility is part of Affy's early efforts to expand its operations in Asia. Those plans include setting up offices in Shanghai and collaborating with state labs in China.


Perlegen and Genentech to Study Genetics of Cancer

Perlegen Sciences announced last week that it has begun a collaboration with Genentech to study the genetics of cancer.

The companies hope to apply findings to the discovery and development of targeted medicines and molecular diagnostics for cancer.

Perlegen uses Affymetrix's GeneChip technology in its high-throughput oligonucleotide array approach.

Terms of the agreement were not disclosed.


PerkinElmer to Use Luminex's xMAP Platform in IVD Development

Luminex will provide access to PerkinElmer to its xMAP technology and assay-development capabilities, PerkinElmer said this week.

Under the agreement, PerkinElmer will standardize its multiplex assay development on the xMAP platform. The company will use the technology in biomarker panels for pharmaceutical development and ADME/Tox, and to develop in vitro diagnostics in maternal, neonatal, and prenatal health.

Additional details were not disclosed.


AstraZeneca Modifies ARMS License to BTG and DxS; New Deal Enables Shops to Outlicense Tech

AstraZeneca modified its agreement with BTG and DxS over licenses for the Amplification Refractory Mutation System, the companies said this week.

Under the improved agreement, BTG and DxS can grant licenses to ARMS and related technologies to other companies.

The original agreement, signed in March 2004, gave BTG and DxS intellectual property rights to commercialize the technology within the diagnostic and research markets.

ARMS is used to detect gene mutations and SNPs.

Details on the agreement were not disclosed.


Keygene Buys 454 Sequencer; First Sequencer 20 Placement for Roche in Europe

Keygene purchased 454's Genome Sequencer 20 system from Roche Diagnostics, the companies announced this week.

Keygene is Roche's first European customer for the sequencing system.

The Genome Sequencer 20 System takes a nanotechnology-based approach to sequencing and was developed by 454 Life Sciences. The system sequences over 20 million bases within a four and a half hour run, Roche said.

Roche, 454 Life Sciences, and Keygene will use the system with Keygene's AFLP and SNPWave technologies for research in plant genetics.


Acacia to Spin Out CombiMatrix as Independent Public Company

Acacia Research said this week that its board of directors has approved a plan for its CombiMatrix microarray subsidiary to become an independent public company.

Acacia said it expects the transaction to close in the second quarter of 2006, subject to receiving a "satisfactory tax opinion from legal counsel" and other conditions.

If these conditions are met, Acacia will redeem all of the issued and outstanding shares of Acacia Research-CombiMatrix common stock, which trades under the ticker symbol CBMX, for all of the common stock of CombiMatrix, which will list its shares for trading on Nasdaq.

The spin-out "will benefit both companies by eliminating the risk factors associated with the current capital structure," Paul Ryan, chairman and CEO of Acacia, said in statement. The separation of the two companies is also expected to make the firms more attractive to investors, he said.


Affymetrix Cuts Q4 Revenue Projection for Second Time

Affymetrix last week said it had cut its fourth-quarter revenue projections by roughly $15 million, or 12.5 percent, below previous guidance.

The company blamed the cut, which is the second one in three months, on low fourth-quarter instrument sales and delays in completing genotyping processing under a services contract.

Affymetrix had originally projected its Q4 revenues to be $130 million. In the fall of 2005, the company cut this projection to $120 million.

Affy also cut its full-year 2005 product-related revenue projection, also for a second time. The company originally projected to generate $390 million in product-releated receipts in 2005, but in the fall of 2005, the firm cut that figure 6 percent to $365 million. In last week's announcement, Affy further cut that projection, this time to $350 million, or an additional 4.3 percent.

Also last week, Affy cut its total 2005 revenue projection by $40 million, or 9.9 percent, to $365 million.

"Affymetrix is experiencing growing pains as it both innovates and commercializes new products in high potential markets," said CEO Stephen Fodor. "We are carrying record orders into 2006 and expect to achieve around 15 percent top-line growth for the full year."


BD Acquires GeneOhm Sciences for $230M in Bid to Bolster Infectious-Disease Play

Becton Dickinson has acquired GeneOhm Sciences for $230 million plus up to $25 million in additional incentives, BD said this week.

GeneOhm is a privately held company headquartered in San Diego that develops molecular diagnostics designed to detect bacteria known to cause healthcare-associated infections. BD said that GeneOhm had 2005 revenues of approximately $5 million, and provides BD with expanded entry into the emerging HAI market.

Specifically, GeneOhm markets FDA-cleared IDI-MRSA and IDI-Strep B diagnostic tests. MRSA, also known as methicillin-resistant Staphylococcus aureus, is responsible for HAIs, and Group B Strep poses a risk to pregnant women and their children during the latter stages of pregnancy.

The acquisition is subject to regulatory approvals and is expected to close by the end of March 2006. BD also said that the GeneOhm transaction is slightly dilutive. However, it reaffirms its previous guidance that reported diluted earnings per share from continuing operations for fiscal year 2006 are expected to be in the range of $3.15 to $3.19. BD said it will provide further details around this guidance during its first quarter earnings call on January 26.


CombiMatrix Adds University of Colorado to CombiCore Program

The University of Colorado Health Sciences Center will buy CombiMatrix's microarray products under the CombiCore access program, Acacia Research, CombiMatrix's parent company, said last week.

Under the non-exclusive agreement, researchers can purchase CustomArrays and CatalogArrays, including array-processing services performed at the university's Microarray Core Facility.

The company markets, sells and delivers products to universities under the CombiCore program.

Financial details were not disclosed.


Charles River Labs Licenses Luminex's xMap Technology

Charles River Labs has licensed Luminex's xMAP technology for use within its research models and services, the companies said last week.

Luminex's xMAP technology enables multiple assays to be performed in a single well, using suspended beads.

 

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