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Signature Diagnostics, Genedata, Agendia, DNAPrint, Kenna Technologies, Sequenom, Affymetrix, Transgenomic, Gene Logic, Genome Express, Affy, Gen-Probe, AmeriPath, NHGRI


Signature Diagnostics Licenses Genedata's Expressionist Tool

Genedata has licensed its Expressionist tool to Signature Diagnostics to create gene profiles in colorectal cancer patients, Genedata said this week.

Signature Diagnostics will use the Expressionist software to process and analyze Affymetrix GeneChip data from thousands of CRC patients currently receiving treatment, Genedata said. The goal is to identify unique gene-expression signatures that predict the risk of recurrence and response to therapy of individual patients.

Signature Diagnostics, based in Potsdam, Germany, collaborates with clinical partners to improve the clinical development of oncology drugs and develops molecular diagnostics for predicting outcome and drug response in cancer patients.

Additional details for the licensing agreement were not disclosed.

Agendia Registers MammaPrint Microarray Test With Dutch Gov't

Agendia has registered its MammaPrint microarray test as a medical device with the Dutch Healthcare Inspectorate, the company said this week. Both the microarray and the array production were registered.

Agendia said the registration complies with Dutch law on medical devices and enables MammaPrint to bear the CE mark. Agendia recently received accreditation for MammaPrint.

The MammaPrint gene-expression service assesses the risk of metastasis in breast cancer patients with a 70-gene profile.

The Amsterdam, Netherlands-based company will also register its other genetic profile-based tests, such as CupPrint, a test for cancer of unknown primary patients.

Sequenom's Q3 Revenues Slide 11.5 Percent as Losses Decline 29 Percent

Sequenom this week said that third-quarter revenue fell 11.5 percent as net losses narrowed 29 percent.

Total receipts for the three months ended Sept. 30 fell to $4.6 million from $5.2 million in the same quarter last year.

Sequenom spent $2.5 million on R&D in the quarter, compared to $3.5 million in the same quarter last year.

Net losses in the third quarter fell to $6 million from $8.3 million year over year, the company said.

"We are continuing to implement cost-cutting measures announced last month as part of our new business strategy," Harry Stylli, Sequenom's president and CEO, said in a statement.

As of Sept. 30, the company held cash, cash equivalents, short-term investments, and restricted cash totaling $19.7 million.

Affymetrix Licenses Microarray Technology to PathWork for Cancer Dx

Affymetrix has granted PathWork Informatics long-term non-exclusive access to its microarray technology to develop and market in vitro diagnostics for cancer.

Under the terms of the agreement, PathWork has the right to use Affymetrix's technology to develop tests for tumors of unknown origin, as well as other cancer tests, Affy said. PathWork will incorporate Affymetrix arrays into PathWorks Oncology Suites, the company's diagnostic kits that are currently under development.

Financial terms of the agreement were not disclosed.

As Expected, Transgenomic Closes $15M Private Placement of Common Stock

Transgenomic has completed its private placement of common stock to a group of institutional investors led by Lehman Brothers, the company said this week.

As GenomeWeb News previously reported, the transaction was originally priced at $1.01 per share for 15 million shares. A company spokesperson confirmed the final amount today as "rounded off to approximately $15 million."

Net proceeds from the sale were used to repay the company's debt of approximately $8.6 million with Laurus Master Fund. The remainder was retained for working capital.

The Omaha, Neb.-based company has committed to preparing and filing a registration statement covering the resale within 30 days of closing.

As Losses More Than Double in Q3, Gene Logic Lays Off Nonclinical Staff, Lowers Full-Year Revenue Projections

Gene Logic last week posted a slight year-over-year increase in third-quarter revenues, but the company's net loss more than doubled over the year, related to impairment of goodwill for its nonclinical business.

Gene Logic lowered its full-year revenue projections due to a "revenue shortfall" in the nonclinical business. The company said in a statement today that it had "reduced the number of employees" in this business segment during the quarter "in order to more properly align staffing with anticipated revenue over the near term."

Further details on the layoffs were not immediately available.

Gene Logic reported total revenues of $17.1 million for the quarter ended Sept. 30, compared to $17.0 million for the third quarter of 2004.

The company's genomics business revenue decreased by 2 percent, to $11.7 million from $11.9 million in the third quarter of 2004, while its nonclinical business revenue increased 3 percent, to $5.3 million from $5.1 million in the prior-year period.

Gene Logic's drug repositioning service business posted revenues of $102,000 for the quarter.

Gene Logic said that revenue for its genomics business for the quarter does not include $2.6 million in revenue for services delivered during the third quarter, which was deferred into future periods, "associated with specific multiple-element contracts." Of this amount, the company said it expects to record at least $1.4 million as revenue in the fourth quarter of 2005, with the remainder to be recorded in future periods.

For the full year 2005, Gene Logic lowered its expectations for total revenue to between $76 million and $78 million, down by as much as 11 percent from previous guidance of $83.5 million to $85.5 million.

The company generated total revenues of $76 million in 2004.

Gene Logic's net loss widened to $39.5 million for the third quarter, compared to $14.6 million in the comparable period of 2004.

The bulk of this loss was due to a $32.8 million charge for impairment of goodwill from its 2003 acquisition of TherImmune Research, now Gene Logic Laboratories, the company's nonclinical business. Previously, the nonclinical business goodwill was valued at $43 million.

R&D spending increased to $1.8 million in the quarter, from $673,000 in the third quarter of 2004.

Gene Logic held cash and cash equivalents of $56.5 million as of Sept. 30.

Gene Logic said that it plans to "achieve profitability" during 2007 and it will have positive cash flows during the year.

Genome Express Signs Partners on 'Mutacancer' Program

Genome Express will collaborate with France's Centre Léon Bérard in Lyon and the Centre Jean Perrin in Clermont Ferrand on the Mutacancer research program, the company said last week.

Under the agreement, the Léon Bérard and the Jean Perrin centers gains access to the French company's technology and will keep the discoveries from the project. Genome Express will own any advances in screening technology.

Mutacancer, a sequencing program for mutational analysis of 300 gene candidates in human cancers, identifies diagnostic and therapeutic targets. The cancer diagnostics and therapeutics program targets breast, colon, and lung cancers.

Research results will be accessible to others in the healthcare sector, the partners said. They will consider offering joint services to the pharmaceutical industry.

Affy, Gen-Probe, AmeriPath Invest $7.5M in TGen's Molecular Profiling

The Molecular Profiling Institute, the commercial arm of the Translational Genomic Institute, secured $7.5 million in capital from AmeriPath, Affymetrix, and Gen-Probe, TGen said last week.

The funding, obtained through a Series B round, will pay for additional molecular tests in breast and prostate cancers. The company will also develop assays through clinical trials targeting patients who best respond to targeted cancer therapies.

Molecular Profiling is a reference laboratory specializing in commercial applications of TGen's research projects and International Genomics Consortium's tissue banking and analysis capabilities. The company has an exclusive license to provide MammaPrintR 70 gene breast cancer prognostic in the United States.

AmeriPath currently provides Molecular Profiling's advanced tests to patients. Gen-Probe will also collaborate with Molecular Profiling to validate and commercialize its investigational PCA3 test for diagnosing prostate cancer.

NHGRI's Collins Says US Must Launch Its Own Biobanking Project

In light of biobanking projects underway in the UK, Iceland, Estonia, and Japan, the US can ill afford to not invest in its own population-based cohort study, Francis Collins said last week.

Speaking at the American Society of Human Genetics conference held in Salt Lake City, Utah this week, the director of the National Human Genome Research Institute said that the falling cost of genotyping, coupled with the completion of the International HapMap Project, has enabled the US to start generating its own repository of genetic information.

He admitted that it would be an "uphill battle" and that the "cost is likely to be in the hundreds of millions of dollars a year" but said the project would pay off in the form of future research. "It might, in fact, in the long-term be a good investment," he said.

Collins said that current "case-control" studies such as the Framingham Heart Study that look at smaller groups of people are valuable, but that if the US really wants to understand the effect that environmental factors play on genetic diseases, researchers will need a "cohort that's selected to cover all ages, all races" and all states of wellness.

Ideally, Collins said that the project would have a large sample size, perhaps from two to three million individuals, with the "full representation of minority groups and a broad range of ages, and a broad range of genetic backgrounds." He said that significant data about participants' lifestyles would be included, and that that information should be made available to all researchers. "This kind of project would only have value if the maximum number of people would have access to it and can draw inferences from it," he said.

Collins acknowledged the ethical issues and potential privacy concerns of such a project, but said he could imagine that most Americans would want to be involved in the study because it would be an historic undertaking.

He added that similar projects in progress around the globe have left the US behind in biobanking endeavors and warned that if "we wait until we get data to start setting [the project up] then we have waited too long."

Filed under

The Scan

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Genetically predicted high blood pressure risk is also associated with increased cardiovascular disease risk, a new JAMA Cardiology study says.

Circulating Tumor DNA Linked to Post-Treatment Relapse in Breast Cancer

Post-treatment detection of circulating tumor DNA may identify breast cancer patients who are more likely to relapse, a new JCO Precision Oncology study finds.

Genetics Influence Level of Depression Tied to Trauma Exposure, Study Finds

Researchers examine the interplay of trauma, genetics, and major depressive disorder in JAMA Psychiatry.

UCLA Team Reports Cost-Effective Liquid Biopsy Approach for Cancer Detection

The researchers report in Nature Communications that their liquid biopsy approach has high specificity in detecting all- and early-stage cancers.