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Celera, Ipsen, LabNow, Qiagen, Health Canada, 23andMe, NIH, CXR Biosciences, Wyeth

Celera and Ipsen to Develop Biomarkers, PGx Tests for Growth Failure Therapies
Celera will help Ipsen develop pharmacogenomic tests that could be used in tandem with Ipsen’s hormone-replacement therapies for short stature, the companies said this week.
Under the first phase of the multi-year collaboration, Celera will work with the Paris-based specialty pharmaceutical company to locate and characterize genetic markers related to growth failure.
Should those efforts produce successful results, the companies will then develop diagnostic predictors that Ipsen could use in clinical trials. These predictors would then “potentially form the basis for commercial companion diagnostic tests for Ipsen's short stature therapies,” the companies said.
Ipsen will pay Celera an undisclosed sum for the initial phase of the collaboration. Any future payments will depend on the success of the initial phase.

LabNow Lands $20M Series B to Develop, Launch HIV/AIDS Assay
Point-of-care diagnostics developer LabNow said this week that it has landed $20 million in Series B equity financing from private and venture investors.
LabNow will use the money for the late-stage development and launch of its CD4Now Biochip and Analyzer device, a CD4 testing system for use in the assessment and treatment of HIV/AIDS patients.
The funding was led by Austin Ventures and Sammons Enterprises, both Texas-based investors that also backed LabNow’s Series A financing, and includes a group of other private investors, the company said.
LabNow, based in Austin, Texas, said its sensor technology analyzes blood and other fluid samples “simply, rapidly, and economically,” and shows promise for healthcare applications as well as environmental and food safety testing and in homeland security applications.
The company said the CD4Now system uses an automated reader and assay-specific disposable chips to generate accurate CD4 cell counts in less than 15 minutes from a single drop of blood.

Health Canada Licenses Qiagen's Hepatitis B Viral Load Assay
Qiagen said this week that Health Canada has licensed its artus PCR-based hepatitis B virus assay to monitor the viral load of HBV-infected patients.
The company said that the assay kit is in compliance with Health Canada's medical device requirements and is now available to doctors in Canada to help evaluate the efficacy of treatment.
Qiagen said that the kit is configured for Roche’s LightCycler RT-PCR instrument and includes reagents to detect the HBV genotypes A-G. The company said these genotypes are “representative of strains of the virus which can be found globally, ensuring highest sensitivity in monitoring of treatments.”
Financial terms of the agreement were not provided.

Fledgling Consumer Genomics Field Fattens up with 23andMe Service Launch
The consumer genomics specialty company 23andMe launched its personalized DNA analysis service this week.
The web-based service uses Illumina's genotyping platform to analyze a DNA sample from saliva that the customer provides. Customers of the service use 23andMe’s web tools and analysis to learn about their genomic profiles and gain information about their ancestry.
23andMe co-founder Anne Wojcicki said in a statement this week that the genomic information “provides intriguing insights into an individual's genetics, with the goal of expanding the collective knowledge base by enabling active participation in research."
The offering, priced at $999, will compete with a similar offering announced last week by Decode Genetics, which has priced its consumer genomics product at $985. Like the Decode service, 23andMe’s service allows consumers to compare their genomes to family and friends that also participate.
Navigenics, another company that recently announced a similar service and will use Affymetrix's genotyping technology, plans to market its personal genomics offering for $2,500.
Privately held 23andMe is backed in part by a nearly $4 million investment from Google.
Illumina CEO Jay Flatley said in a statement that the consumer genomics services “will open up a new world of genetic awareness that could complement traditional research efforts in ways we haven't even considered."

House Fails to Override Bush Veto on HHS Budget Bill to Increase NIH Spending
The US House of Representatives in a late session last week, voted not to override President Bush’s veto of a large appropriations bill that would raise 2008 funding marked for the National Institutes of Health to $30 billion.
Current funding is at $28.5 billion, and the President in his budget asked for $28.7 billion, an increase that would not keep pace with inflation, according to the Association for the Advancement for Sciences, which tracks federal research funding.
Bush sent the bill back to Congress with the chide that the legislation was loaded with irresponsible spending. White House spokeswoman Dana Perino said Bush felt the bill, which would provide funding for the Department of Health and Human Services, as well as the Departments of Labor and Education, would spend over $10 billion more than the amount he had wanted.
After a vote that nearly achieved the two-thirds majority necessary to override a presidential veto, with representatives voting 277 for and 114 against, HR 3043 will not become law until some compromise is reached between the House, Senate and White House.
That leaves the NIH, along with the other bodies funded by HHS and the Departments of Labor and Education, operating on interim funding until the new budget is passed.
With the arrival of the Thanksgiving break it seems unlikely the bill will be sent back to the Senate and White House until December.

CXR Biosciences, Wyeth Collaborate on $6.2M Drug Toxicity Marker Study
The Scottish company CXR Biosciences said last week it will work with the University of Dundee and Wyeth Pharmaceuticals in a £3 million ($6.2 million) collaboration to seek protein biomarkers that indicate the toxic effects of certain drugs.
CXR Bio said the three-year project is co-funded by the Technology Strategy Board and will be conducted in part by Wyeth scientists and by core lab staff at the Translational Medicine Research Center in Dundee.
The study intends to identify these markers and then develop assays to measure possible toxic effects of new drugs before they develop.
These assays then would be used in the lab to identify drug candidates that present too high of a risk to human safety to be advanced into clinical trials. They also could be used to give warnings of drugs that could lead to harm if the treatment is continued or if the dosing is increased, the company said.
CXR Bio did not provide details about who will have ownership of intellectual property resulting from the collaboration.

Filed under

The Scan

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A Yale University-led team examines in The BMJ safety signals from the US FDA Adverse Event Reporting System and whether they led to regulatory action.

Duke University Team Develops Programmable RNA Tool for Cell Editing

Researchers have developed an RNA-based editing tool that can target specific cells, as they describe in Nature.

Novel Gene Editing Approach for Treating Cystic Fibrosis

Researchers in Science Advances report on their development of a non-nuclease-based gene editing approach they hope to apply to treat cystic fibrosis.

Study Tracks Responses in Patients Pursuing Polygenic Risk Score Profiling

Using interviews, researchers in the European Journal of Human Genetics qualitatively assess individuals' motivations for, and experiences with, direct-to-consumer polygenic risk score testing.