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Illumina, Avantome, Roche, Metabolon, UT Health Science Center, FDA, Response Biomedical, NY State Department of Health, Rosetta Genomics, Cellumen, Cernostics Pathology, Celera, Toyota Tsusho America, Nippon Kayaku

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Illumina Posts 66 Percent Revenue, Profit Gain in Q2; Acquires Sequencing Startup
 
Illumina reported this week that its second-quarter revenues and profit each increased 66 percent year over year. The firm also said that it has acquired Avantome, a privately held developer of low-cost, long read-length sequencing technology.
 
Illumina brought in revenues of $140.2 million for the three months ended June 29, 2008, compared to revenues of $84.5 million for the second quarter of 2007.
 
The firm posted a profit of $15.4 million, or $.23 per share, compared to net earnings of $9.3 million, or $.16 per share, for the second quarter of 2007. The most recent quarter includes a $4.1 million charge of impairment of manufacturing equipment and a $2.7 million charge for amortization of intangible assets compared with a $662,000 charge in the second quarter of 2007 for amortization of intangible assets.
 
Illumina said in a statement that the impairment charge relates to the write-off of its prior generation manufacturing equipment, which resulted from “the faster than anticipated customer transition to the new Infinium HD product line.”
 
Illumina’s R&D costs rose 28.6 percent to $23.5 million from $18.2 million for the comparable period of 2007, while its SG&A expenses increased 52.8 percent to $35.6 million from $23.3 million.
 
The San Diego-based firm finished the quarter with $133 million in cash and cash equivalents.
 
Illumina also announced that it will acquire DNA sequencing technology startup Avantome, which was co-founded by Mostafa Ronaghi, a senior research associate at the Stanford University Genome Technology Center. Under the terms of the acquisition, Illumina will make an up-front payment of $25 million and contingent payments of up to $35 million for Avantome.
 
Ronaghi has been developing a miniaturized pyrosequencer under a three-year, $1.8 million Advanced Sequencing Technology award that he received in 2004 from the National Human Genome Research Institute.
 
Ronaghi will join Illumina as senior vice president and chief technical officer following the deal, and Avantome co-founder Helmy Eltoukhy will join the firm as director of Avantome sequencing development.
 
Illumina expects to close the acquisition in the next few weeks.
 

 
Roche's MDx, Applied Science Revenues Rise in First Half of 2008
 
Roche this week reported that its molecular diagnostics revenues increased 4 percent while its applied science revenues rose 21 percent for the first half of 2008.
 
Roche said that its molecular diagnostic sales for the six-month period ended June 30 were 551 million Swiss francs ($541.5 million). The firm cited sales of its fully automated tests for HIV and hepatitis B and C as the key drivers of revenue for its virology diagnostics. It noted, though, that blood screening revenues declined due to pricing pressure.
 
Sales for Roche Applied Science totaled 367 million Swiss francs, with growth driven by the firm’s Genome Sequencer FLX, LightCycler 480 platform, and microarrays. Roche noted that its sequencing product sales more than doubled for the first half of the year even though there has been increased pressure from competitors.
 
Overall, the diagnostics division, which houses both the molecular diagnostics and applied science businesses, reported revenue growth of 11 percent to 4.7 billion Swiss francs for the first half.
 
Roche said that sales from Ventana Medical Systems, which it acquired in February for $3.4 billion, were 164 million Swiss francs. The firm said Ventana’s results were “even stronger” than expected.
 
The Roche Group had total first-half revenues of 22 billion Swiss francs, up 4 percent in local currencies. Its net income was 5.7 billion Swiss francs.
 
Sales for Roche’s pharmaceutical division, which includes Roche Pharmaceuticals, Genentech, and Chugai, were 17.3 billion Swiss francs for the first six months of 2008, up 3 percent.
 
Roche reaffirmed its full-year guidance of high single-digit revenue growth.
 
The firm also made an offer this week to acquire the 44.1 percent of Genentech that it doesn’t already own for $89 per share, or $43.7 billion.
 

 
Metabolon, UT Health Science Center Collaborating on Diabetes Dx
 
Metabolon said this week that it is collaborating with researchers at the University of Texas Health Science Center at San Antonio on the development of Metabolon’s pre-diabetes diagnostic products.
 
Research Triangle Park, NC-based Metabolon will analyze samples from studies being conducted by Ralph DeFronzo and his colleagues at UTHSC in an effort to discover and validate biochemical biomarkers reflective of insulin resistance and beta cell dysfunction. The markers will be used by Metabolon to develop diagnostic tests for insulin resistance and how this relates to the risk of developing metabolic diseases, such as diabetes.
 
Metabolon hopes to develop a test that can help physicians “identify asymptomatic, pre-diabetic patients years before they become diabetic,” John Ryals, CEO of Metablon, said in a statement.
 
Further terms of the alliance were not disclosed.
 

 
FDA Clears Response Biomedical's Heart Failure Dx Test
 
The US Food and Drug Administration has cleared a Response Biomedical point-of-care test that serves as an aid in diagnosing heart failure, the company said this week.
 
The RAMP NT-proBNP test identifies the marker for BNP, which is secreted from the heart’s left ventricle in response to pressure overload, and it regulates blood pressure, electrolyte imbalance, and fluid volume.
 
Elevated levels of the NT-proBNP indicate heart failure, and can be used for early detection and management, according to Vancouver, BC-based Response Biomedical.
 
The test “supports the drive for speed and accuracy of diagnosis for patients presenting in emergency rooms and for early detection in ambulatory care,” said Response Biomedical CEO S. Wayne Kay.
 
Kay also said that the test is “clinically concordant” with Roche’s Elecsys proBNP test, allowing hospitals to standardize their decisions based on tests from their emergency rooms and central labs.
 
Affecting nearly 17 million people worldwide, heart failure is “the single most frequent cause of hospitalization in people over 65 years,” the company said.
 
Response Biomedical recently granted Roche Diagnostics the rights to market its cardiovascular point-of-care tests. 
 

 
NY State Approves Rosetta's MicroRNA Test for Lung Cancer
 
Rosetta Genomics said this week that the New York State Department of Health Clinical Laboratory Evaluation Program has approved the use of the firm’s microRNA-based test for differentiating squamous from non-squamous non-small cell lung cancer.
 
Rehovot, Israel-based Rosetta said that the test classifies squamous-cell carcinoma of the lung with sensitivity of 96 percent and specificity of 90 percent. It is Rosetta’s first molecular test to be commercialized.
 
Rosetta President and CEO Amir Avniel said in a statement that the firm’s microRNA platform has enabled its partner, Columbia University Medical Center, “to develop a highly sensitive and specific test, which is a key for optimal administration of targeted therapies” for lung cancer.
 
Rosetta said that CUMC is currently "finalizing the commercial aspects" of the test and will announce its clinical availability "once details are finalized later this year."
 
The firm is developing two other microRNA-based tests, one for mesothelioma and one for cancer of unknown primary, which it expects to be validated and submitted for regulatory approval in the second half of this year.
 

 
Cellumen Spins Off Personalized Medicine Company
 
Cellumen said last week that it has spun off its personalized medicine unit, called Cernostics Pathology.
 
Pittsburgh-based Cellumen said that Cernostics will provide digital imaging pathology and tissue-based diagnostics products and services for personalized medicine applications. It added that the spinout would build on Cellumen’s current collaborations with partners, such as the Mayo Clinic and Foundation, in developing a breast cancer diagnostic and theranostic test.
 
“Cellumen will maintain its core business by focusing on the interface between early drug discovery and early toxicity testing,” Lansing Taylor, CEO of Cellumen, said in a statement.
 
Taylor will serve as chairman of Cernostics Pathology, and Michel Nederlof will join the new firm as president and chief technology officer. Nederlof recently was the founder and president of QED Imaging, which is now part of Media Cybernetics.
 

 
FDA Clears Newest Version of Celera's HIV-1 Genotyping Software
 
Celera said last week that the US Food and Drug Administration has granted marketing clearance for the firm’s ViroSeq HIV-1 Genotyping System Software v2.8.
 
The Alameda, Calif.-based firm’s HIV-1 Genotyping System detects mutations in the HIV-1 viral genome that confer resistance. It is used by physicians in monitoring and treating HIV-1 infections.
 
The newest version of the software includes the resistance algorithm for two new anti-HIV drugs, Intelence (etravirine) and Prezista (darunavir). It also includes an update of the resistance algorithm for all currently available protease and reverse transcriptase inhibitors, said Celera.
 
The ViroSeq system is manufactured by Celera and distributed by Abbott Laboratories.
 

 
New Joint Venture to Market Diabetes Test, Develop Biomarkers
 
Toyota Tsusho America and Nippon Kayaku have formed a joint venture that will focus on discovering and selling novel biomarkers and biomarker-based tests for diabetes.
 
The new company, which is called GlycoMark and is located in Winston Salem, NC, and in New York, will sell the GlycoMark diabetes blood test, which the two companies previously commercialized together through a partnership. The GlycoMark test is used to guide management of diabetic patients and for clinical trials on diabetes drugs.
 
The new company initially will focus its efforts on continuing to commercialize the GlycoMark lab test with partner labs in the US, and it also plans to introduce the test in the European Union. The joint venture also is developing a point-of-care and home-test version of the GlycoMark.
 
Toyota Tsusho America is a New York, NY-headquartered company with seven operating divisions, including chemicals, metals, machinery, consumer products and others, and Nippon Kayaku is a fine chemicals manufacturer based in Tokyo.

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