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Clinical Data, Diagene, Bio-Rad, Ciphergen, Illumina, Solexa, Qiagen, DeCode, Agendia, Teva & Tuteur

Clinical Data, Diagene Sign Cardiac Channelopathy Test Distribution Deal for Germany, Switzerland, Austria
Clinical Data announced this week that its PGxHealth division has entered into a distribution agreement with Diagene GmbH.
Under the agreement, Europe-based Diagene will have exclusive rights to market and sell Clinical Data's Familion test — a genetic test designed to identify mutations in people with inherited cardiac channelopathies such as Long QT Syndrome (LQTS) and Brugada Syndrome — in Germany, Switzerland, and Austria.

Bio-Rad Closes Acquisition of Ciphergen Life Science Research Business
Bio-Rad announced this week the purchase of Ciphergen Biosystems’ ProteinChip Systems business and worldwide technology rights to its Surface Enhanced Laser Desorption/Ionization (SELDI) for approximately $20 million.
“The acquisition includes certain product lines, manufacturing capability, and intellectual property as well as access to Ciphergen's life science customer base,” the company said in a statement.
Under the terms of the deal, Ciphergen will retain rights to the diagnostics market, and Bio-Rad will supply instruments and reagents to Ciphergen to support its diagnostics business under a separate agreement.
Bio-Rad also garnered a $3 million equity investment in Ciphergen as part of the transaction.

Illumina Acquire Solexa in $600M Stock Deal, Targets $2.25B Market for Combined Genotyping-Sequencing Platform
Illumina said this week it will acquire next-generation sequencing firm Solexa in a stock deal worth approximately $600 million.
Under the terms of the agreement, Solexa shareholders will receive Illumina common stock at $14 per share, and Illumina will invest $50 million in Solexa for newly issued Solexa shares.
Solexa’s shares were trading at $9.70 at market close on Friday, the last trading day before the acquisition was announced, and the company’s market capitalization was $354 million.
Illumina said the deal should close by the first quarter of 2007, although it is still subject to regulatory approval as well as that of both companies' stockholders.
Illumina claimed that the merger will create “the only company with genome-scale technology for genotyping, gene expression, and sequencing,” and estimated that the market opportunity for Solexa's genetic analysis system combined with its own technologies will be around $2.25 billion. 
Solexa CEO John West, who will join Illumina as senior vice president and general manager of the sequencing business, said that together the two companies "expect to reach and exceed the milestone of the $100,000 genome."
Illumina said it expects to retain Solexa's offices in Hayward, Calif., and in Cambridge, UK, and added that Illumina will add two Solexa board members to its board of directors.
Illumina expects the acquisition to be “significantly accretive” after 2008.
Solexa generated $4.2 million in revenues in 2005, although none of its revenues to date have come from its sequencing platform. This week, Solexa reported a 33-percent decrease in its third-quarter revenues.

Strong Consumables Sales Help Qiagen Post 20-Percent Revenue Gain in Q3
Qiagen this week said third-quarter revenues increased 20 percent as R&D spending rose 29 percent and profit increased 10 percent.
Total receipts for the three months ended Sept. 30 increased to $117.9 million from $98.6 million year over year, beating its guidance of $116 million.
The largest gains came from consumables sales, which conributed 20 percent to the growth. Around 7 percent of the quarter’s revenue came from Genaco Biomedical, which Qiagen acquired in October for $22 million in cash.
Sales in Asia also contributed to the company’s expansion as Qiagen saw a 63-percent increase in revenue in Asian markets.
R&D spending increased to $10.1 million from $7.8 million year over year.
The company said profit increased to $19.4 million from $17.6 million in the year-ago period.
Qiagen said it had around $492 million in cash and equivalents as of Sept. 30.

DeCode Posts 35-Percent Rise in Q3 Revenue as Net Losses More Than Double
DeCode Genetics’ third-quarter revenues decreased 35 percent as R&D spending rose 29 percent and loss increased 108 percent, the company reported last week.
Total receipts for the three months ended Sept. 30 decreased to $8.6 million from $13.2 million year over year. DeCode blamed the decline on lower alliance revenues in 2006, and because $11.8 million in revenue was deferred to future reporting periods.
R&D spending increased to $14.2 million from $11 million year over year. DeCode said steady increases in R&D throughout the year are from drug discovery, clinical trials, and SNP analysis covering several disease areas.  
The company’s net loss increased to $23.6 million from $11.3 million in the year-ago period. The losses came from increased spending on research and in a shift in accounting standards regarding DeCode’s share-based compensation.
DeCode said it had around $126.8 million in cash and investments as of Sept. 30.
DeCode also said that the trial for a lawsuit it filed [see PGx Reporter 10-04-06] against five former employees and the Children’s Hospital of Philadelphia in September for allegedly stealing trade secrets to set up a competing lab is expected to resume this month

Agendia Signs Distribution Agreement With Teva & Tuteur For Breast Cancer Microarray Testing
Agendia, an Amsterdam-based diagnostics company, and Teva & Tuteur, an Argentinean pharmaceutical and diagnostic company, signed a distribution agreement this week that provides Teva & Tuteur with the exclusive rights to sell Agendia’s MammaPrint in Argentina and Paraguay.
The MammaPrint is a customized microarray test that translates a 70-gene prognosis profile to predict disease outcomes in breast cancer patients.
“Using the MammaPrint microarray test in the clinical setting provides more accurate information on recurrence risk as compared to conventional clinical criteria and thus improves patients’ management for women diagnosed with breast cancer,” Agendia Chief Operating Officer Laura van't Veer said in a statement. “As a direct result, many patients get the appropriate treatment leading to improved outcome or reduced side effects thus improving quality of life and reducing healthcare costs.”
According to Agendia Chief Executive Officer Bernard Sixt, the firm is “putting a lot of resources and effort” into expanding MammaPrint’s demand and availability globally.

FDA Improves Average 510(K) Product Review Time, Agency Says
For fiscal year 2005, the average US Food and Drug Administration’s review time was 49 days, a 23 percent improvement from its previous record of 64 days in fiscal year 2004, the agency found. FDA’s own 510(k) review performance data “shows the average FDA review time from receipt to final decision has steadily declined from FY 01 through FY 05,” the agency said in a release.
In 2005, FDA received 240 510(k)s reviewed by third-party organizations. The average number of days, from receiving the 510(k) from third-party reviewers to issuing the final decision, decreased by five days in 2005, from 35 days the previous year.
FDA’s CDRH has stressed that it has taken steps during the last fiscal year to improve the quality and consistency of third-party reviews and issue timely CDRH action on submissions.

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The Scan

Octopus Brain Complexity Linked to MicroRNA Expansions

Investigators saw microRNA gene expansions coinciding with complex brains when they analyzed certain cephalopod transcriptomes, as they report in Science Advances.

Study Tracks Outcomes in Children Born to Zika Virus-Infected Mothers

By following pregnancy outcomes for women with RT-PCR-confirmed Zika virus infections, researchers saw in Lancet Regional Health congenital abnormalities in roughly one-third of live-born children.

Team Presents Benchmark Study of RNA Classification Tools

With more than 135 transcriptomic datasets, researchers tested two dozen coding and non-coding RNA classification tools, establishing a set of potentially misclassified transcripts, as they report in Nucleic Acids Research.

Breast Cancer Risk Related to Pathogenic BRCA1 Mutation May Be Modified by Repeats

Several variable number tandem repeats appear to impact breast cancer risk and age at diagnosis in almost 350 individuals carrying a risky Ashkenazi Jewish BRCA1 founder mutation.