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MD Anderson, Sequenom, FDA, CDC, Affymetrix, Iconix, Ciphergen, Sanofi-Aventis, 454, Illumina, Luminex, Oxford GKP, Decision Biomarkers


MD Anderson to Use Sequenom Systems for Epigenomic and Genotyping Research

The MD Anderson Kleberg Center for Molecular Markers at the University of Texas has purchased Sequenom's MassArray genetic analysis system and iPlex assay, Sequenom said this week.

The technology will be used for the center's molecular marker research and individualized cancer case initiatives, according to a statement. Researchers at the center will use the systems to identify individuals at high risk for developing specific types of cancer, develop screeing approaches for early diagnosis of cancer, and "tailor therapy to the genetic make-up of each patient."

Financial details were not provided.

FDA Approves CDC's RT-PCR Test for Avian Flu

The US Food and Drug Administration said last week that it had approved a CDC-developed diagnostic for H5 strains of avian influenza in human patients.

The Influenza A/H5 Virus real-time RT-PCR primer and probe set provides preliminary results on suspected samples within four hours of testing, said the FDA in a statement.

"Using flexible regulatory authorities, FDA was able to prioritize this expedited approval based on the clear critical need," said acting FDA commissioner Andrew von Eschenbach.

Additional information can be found here.

Affymetrix and Iconix to Co-develop Drug Toxicology Research Tools

Affymetrix and Iconix Pharmaceuticals plan to co-develop products to help study the toxicological and pharmacological properties of drugs and drug candidates, the firms said this week.

Under the terms of the agreement, Affymetrix will combine its GeneChip platform with Iconix's DrugMatrix 640 compound reference database and analysis software. Researchers will also be able to compare gene-expression profiles to Iconix's Drug Signatures library to help predict the impact that gene-expression changes may have on the body's toxic response, the companies said.

Financial terms were not disclosed.

Ciphergen and Sanofi-Aventis Extend Alliance to Include Oncology Biomarker ID, Validation

Ciphergen this week said it will discover, validate, and identify biomarkers for a pre-clinical oncology drug efficacy study for Sanofi-Aventis.

Under the terms of the agreement, which is an extension of an earlier deal between the two companies, Ciphergen will analyze samples at one of its Biomarker Discovery Center laboratories using its suite of proteomic products, including PatternTrack Process and the ProteinChip System.

Financial terms were not disclosed.

454 Posts $7.3M in Q4 Revenues; Plans to Release New Sequencing Application Later This Year

454 Life Sciences, a majority-owned subsidiary of Curagen, generated $7.3 million in revenue in the fourth quarter of 2005, nearly 70 percent of its parent company's total consolidated revenues for the quarter, the company said last week.

The company also said it plans to release an ultra deep sequencing application later this year.

454's fourth quarter revenues came from sales of instrument systems and proprietary reagents, fees for service sales and royalties, as well as $900,000 in grant revenue, CuraGen said in a release. 454 generated $597,000 in revenue during the fourth quarter of 2004.

Licensing of 454's Genome Sequencer 20 system, which is distributed by Roche Applied Sciences, more than doubled in the fourth quarter as compared to the first nine months of 2005, resulting in a year-end total of 20 sequencers being used worldwide, said the company.

CuraGen forecast that 454 will generate between $30 million and $35 million in revenues in 2006.

The company expects development expenses in 2006 ranging from $65 million to $70 million and administrative expenses of about $23 million, "related primarily to the support of 454 Life Sciences' continued growth."

Among those developments, the company announced plans to release an ultra deep sequencing application in mid-2006. The technology "takes advantage of Genome Sequencer 20's capability to analyze greater than 200,000 unique DNA molecules in a single instrument ... to analyze genetic variation within viral samples, including HIV ... or tumors," the company said.

At the same time 454 will release enhanced features for whole-genome sequencing applications, including support for paired reads and software for the mapping and de novo assembly of genomes as large as 1 billion bases.

The company expects to incur $7 million to $15 million in expenses during 2006 to support continued investment in next-generation sequencing technologies. 454 currently has sufficient cash and investments to support that spending, a company spokesperson told Pharmacogenomics Reporter sister publication GenomeWeb News.

Illumina Reports 55-Percent Gain in Q4 Revenue as R&D Spending Surges and Profit Slides

Illumina last week reported that fourth-quarter revenue increased 55 percent amid a sharp increase in R&D spending and a decline in profits.

Total receipts for the three months ended Jan. 1 swelled to $23 million from $14.8 million year over year, the company said. Product receipts increased 67 percent year over year to $16.7 million while service and "other" revenue increased 43 percent to $5.7 million. Research receipts grew to $609,000 from $321,000 year over year, Illumina said.

R&D spending in the fourth quarter increased 42 percent to $7.5 million from $5.3 million year over year.

Net profit in the current quarter declined to $326,000, or $.01 per basic share, from $3.2 million, or $.09 per basic share year over year. Illumina attributed the decrease to a one-time gain during the fourth quarter 2004 related to reduced damages awarded in a wrongful termination suit.

Illumina said it had around $50.8 million in cash and investments as of Jan. 1.

Looking ahead, the company said it expects 2006 revenue to increase between 55 percent and 70 percent to between $115 million and $125 million, driven primarily by organic growth in its genotyping products.

Illumina also said it expects R&D spending during the year to decline as a percentage of total revenue, and should come in at between $30 million and $34 million.

For the first quarter, Illumina said it expects total receipts to range between $22 million and $24 million, which would be a year-over-year increase of between 46 percent and 59 percent.

Luminex Posts 27-Percent Jump in Q4 Revenue; Greater R&D Spending Contributes to Widened Loss

Luminex last week said that fourth-quarter revenue increased 27 percent atop a surge in R&D spending and widened net loss.

Total receipts for the three months ended Dec. 31 increased to $11.6 million from $9.1 million year over year. Luminex said these receipts comprised $6.1 million in sales of its Luminex Systems; $2.3 million in consumables sales; $1.5 million in royalties; and $1.7 million in "other" revenue.

CEO Patrick Balthrop said the company is "very pleased with the momentum in our business and our prospects for 2006." He said the firm has more than 3,400 Luminex Systems in the marketplace, "providing us with the opportunity to leverage this asset and we anticipate realizing higher consumables per placed system.

"We will continue to work closely with our strategic partners to enhance end-user acceptance of our xMAP technology and we remain committed to making the appropriate R&D investments to keep pace with market demand," Balthrop added.

R&D spending in the quarter surged to $1.6 million from $908,000 year over year.

Luminex said that net loss during the fourth quarter increased to $1.3 million, or $.04 per share, from $1.2 million, or $.04 per share, in the year-ago quarter.

Luminex said it had around $25.2 million in cash and equivalents and $11 million in short-term investments as of Dec. 31.

Oxford GKP Picks up OGT Microarrays for NHS Labs

OGT Services announced this week that Oxford Genetics Knowledge Park is using its custom-made microarrays to develop tests for use in NHS Regional Genetics Laboratories.

The microarrays will be used to develop tests for complex diseases such as colorectal cancer, cardiovascular diseases, and learning disabilities, said OGT.

Financial details of the deal were not disclosed.

Decision Biomarkers Raises $7.6M in Series A Funding

Decision Biomarkers closed a $7.6-million Series A financing round, the company said last week.

Oxford Bioscience Partners led the round. Investors included Rock Maple Ventures, Fletcher Spaght Venture Partners, and a group of individual investors led by Coco Montagu.

The company said it would use the capital to "fast-track" its technology for reducing "overall drug development costs."

"This funding will be used to complete the product launch and achieve early sales," said CEO Roger Dowd in a statement.

The Waltham, Mass.-based company makes a fully automated platform that enables researchers to test up to 40 biomarkers at one time.

Filed under

The Scan

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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.