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BioArray Briefs: 2009.02.24


Signature Genomics Labs Gets NY State Clinical Lab Permit

Signature Genomics Laboratories has received its New York Clinical Laboratory Permit, allowing the firm to receive specimens drawn by clinical laboratories in the state of New York for testing.

The Spokane, Wash.-based firm said this week that it is the first laboratory to receive a New York permit to perform microarray-based comparative genomic hybridization. It uses the technology, called SignatureChip, for the genetic evaluation of individuals with unexplained mental retardation and birth defects.

The firm noted that the New York State Clinical Laboratory Permit is issued annually. Signature also holds licenses as an out-of-state clinical lab in Rhode Island, Florida, and California.

Clinical Reference Lab to Handle Lab Services for HTG

High Throughput Genomics said today that it has signed an agreement with Clinical Reference Laboratory Global Services under which it will perform lab services for HTG's clients.

CRL Global Services provides testing for toxicology, molecular diagnostics, bioanalytics, and clinical trials. Under the deal, it will evaluate samples or sample plates using HTG's quantitative nuclease protection assay ArrayPlate technology and reagent kits.

HTG's automated qNPA technology measures gene expression levels of mRNA and miRNA in cells, blood, saliva, and tissues.

CRL Global Services will start offering its services to HTG clients through its CLIA-certified molecular diagnostics lab beginning this spring.

California Clears Decode Genetics' Clinical Lab

The State of California has cleared Decode Genetics to market its genotyping tests to the state’s physicians and residents by giving the company a clinical laboratory license, Decode said last week.

The state had forbidden Decode and a number of other firms from offering genetic tests directly to consumers last summer. At the time, California officials said that these companies were not in compliance with state law governing lab compliance and certification, and that there were concerns about physician oversight of the services.

Decode CEO Kari Stefansson said in a statement that the company is unique in that it discovers genetic risk factors for common diseases and brings to market reference lab tests and DTC scans. "Our competitors outsource the science, the DNA-analysis, or both," he said. "But for us this is the real foundation of personalized medicine."

Kreatech, BioMicro Set European Distribution Pact

Kreatech has begun distributing BioMicro Systems' products in Germany, France, and in the BeNeLux regions, where the company's sales organization is based. The companies also are engaging in co-development projects.

The agreement is structured similarly to a 2007 agreement between the two companies that enables BioMicro to distribute Kreatech's Universal Linkage System labeling portfolio in the US.

Kreatech Vice President of Sales and Marketing Harald Berninger said in a statement that BioMicro's microfluidic and microarray technologies "address the same customer segment as the one we have been targeting with our … ULS labeling technology."

BioMicro CEO Michael Feldman added that the companies are collaborating to develop technologies for the cytogenetics market. Berninger said that BioMicro's Maui hybridization and washing systems potentially could be used in cytogenetics, and that the companies may co-develop new products and specific applications in that area.

DNAStar Taps Infogen for European Sales

DNAStar has signed up Infogen to distribute its gene expression software in several European nations, the company said last week.

Under the agreement, Infogen has gained the rights to sell the ArrayStar software, which is used to visualize and analyze gene expression data, in the UK, Ireland, Italy, Spain, and Greece.

The ArrayStar line was launched in 2007, and it has been expanded to handle applications from data generated by next-generation sequencing platforms, DNAStar said.

“We have seen continuing demand for ArrayStar and felt that our best way to capture this business was by adding to our distribution organization,” Bob Steinhauser, DNAStar’s director of marketing, said in a statement.

Steinhauser said Infogen possesses the “technical expertise" required to sell and to support the ArrayStar software. He added that the company, which has bases in the UK and in Italy, has important knowledge of local markets.

Agilent Posts Falloff in Q1 Revenues and Profit, Plans More Layoffs

Agilent Technologies reported after the close of the market on Tuesday that total revenues for its first fiscal quarter fell 16 percent while net income dropped 47 percent as the company "felt the full brunt of the severe, worldwide economic downturn,” President and CEO Bill Sullivan said in a statement.

For the quarter ended Jan. 31, 2009, Agilent's total revenues fell to $1.17 billion from $1.39 billion — "well below" the company's expectations, Sullivan said.

While the firm's Bio-Analytical Measurement revenues fell 1 percent year over year, that segment was a relative bright spot for the firm, which saw revenues for its Semiconductor and Board Test and Electronic Measurement segments plummet 49 percent and 23 percent, respectively.

Agilent posted first-quarter net income of $64 million, or $.18 per share, compared to $120 million, or $.31 per share, in the year-ago period.

Sullivan said that the company plans to expand a restructuring plan it announced in December, in which it took steps to lay off 500 full-time staffers in order to save approximately $65 million per year.

Under the expanded restructuring initiative, the company will close two small board-inspection businesses and "begin a restructuring of its global infrastructure operations." This will require the layoff of another 600 staffers and will reduce annual operating costs by around $150 million, Agilent said.

The cost of the restructuring should be in the range of $100 million.

The company's Bio-Analytical Measurement business, which includes its Life Sciences and Chemical Analysis businesses, posted a 2 percent dip in orders to $523 million from $532 million in the year-ago period — the end of a nearly three-year period of double-digit order growth for the business, the company said. Bio-Analytical revenues fell 1 percent to $525 million from $531 million.

Geographically, the Bio-Analytical business saw the most weakness in Europe, which was down 11 percent from the comparable period a year ago. Revenue in the Americas was up 1 percent, while Asia was up 10 percent from the prior-year period, with "particular strength" in China.

Agilent said that its gas chromatography and liquid chromatography product lines were relatively weak for the quarter, while microarrays and liquid chromatography/mass spectrometry grew in the double digits over last year.

Within the BioAnalytical segment, the Life Sciences group posted revenues of $238 million, down 1 percent from one year ago. Agilent said that spending by pharma and biotech customers fell 8 percent, "with weakness in replacement business, while consumables and services remained steady."

Agilent saw 20 percent growth in Life Science sales to the academic and government sectors, however, "with particular strength in microarrays and LC/MS systems."

Agilent's total R&D spending for the first quarter fell 7 percent to $169 million from $181 million in the year-ago period. SG&A expenses declined 10 percent to $396 million from $441 million.

Sullivan said that it is difficult for the firm to provide guidance in the current economic climate. “We don’t know where, or when, this recession will bottom," he said. “Forecasting in the current environment is almost futile, as visibility is virtually nil."

The company's "best guess," he said, is that second quarter revenues will be "roughly in line" with first-quarter results.

As of Jan. 31, Agilent had $1.36 billion in cash and cash equivalents.

Scienion Receives ISO Certification

Scienion said last week that it has received certification for its microarray offerings and dispensing systems from the International Organization for Standardization.

The genomics and proteomics products-maker said it received the ISO certification from the German national certification body, TUV Rheinland, in December 2008.

CEO Holger Eickhoff said in a statement that the ISO 9001 certification of its development and manufacturing programs and systems will increase international confidence in its ultra-low volume liquid handling product line and for its microarray services.