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US House of Representatives, The Genetic Information Nondiscrimination Act, Qiagen, Roche, Ortho Clinical Diagnostics, Clinical Data, Newcastle University, Geneservice

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House Bill Seeks to Prohibit All New Human Genome Patenting
 
A bill introduced recently in the US House of Representatives seeks to eliminate the practice of gene patenting.  
 
The Genomic Research and Accessibility Act would add language to existing US patent legal code prohibiting the patenting of human “genetic material.” The bill, if passed, would not apply to patents previously issued. 
 
According to the bill’s sponsors – Xavier Becerra, a Democrat from California, and Dave Weldon, a Republican from Florida – the legislation “would put an immediate end to any and all patenting of the human genome.”
 
Currently, the legislation is awaiting review by the House Committee on the Judiciary.
 
Lynn Rivers, a Democrat from Michigan, had previously introduced a version of the bill to the House in 2002.
 
In a statement, Weldon said gene patenting “is preventing critical research from advancing,” and said the bill is “a common sense measure to ensure that genes yet unpatented remain the province of science.”
 
The introduction of the bill coincided with the release of a study in Nature Biotechnology, which states that while patent offices in Europe and in Japan have “only granted between 3 percent and 5 percent of patent applications,” the US is granting “far more of these patents.”
 
Weldon and Bacerra are also against the principle of ownership of genetic material. In the statement, Bacerra said that “one-fifth” of the human genome “is owned by someone else.”
 
“The practice of gene patenting … not only violates the spirit of the Human Genome Project, it hinders the discovery of medical breakthroughs that could save lives,” Weldon said.  
 

 
Genetic Nondiscrimination Bill Marked Up in House of Representatives
 
The Genetic Information Nondiscrimination Act, previously stalled in the US Congress for more than a decade, was marked up in the House of Representatives for the first time last week.
 
The bill, known as GINA, was introduced in the House 12 years ago by Rep. Louise Slaughter. Political opposition had prevented it from ever coming to a vote in the House, even though it had been unanimously approved by the Senate on two separate occasions.
 
“Today's action is the first time a House Committee has marked up genetic nondiscrimination legislation,” Slaughter said in a statement. The bill was marked up by the House Committee on Education and Labor.
 
The bill, also known as H.R. 493, aims to bar insurance companies and employers from discriminating against people based on genetic information. It must still be considered in the Energy and Commerce Committees and the Ways and Means Committee.
 
GINA was re-introduced to the House on Jan. 16 by Slaughter, a Democrat from New York, and Rep. Judy Biggert, a Republican from Illinois. Around 150 representatives co-sponsored the bill. 
 
According to Slaughter and Biggert, GINA will make it illegal for group health insurers to deny coverage to healthy people based “solely on a genetic predisposition to a specific disease,” and will forbid employers from using genetic information “when making hiring, firing, job placement or promotion decisions.”
 
In a Democratically controlled Congress the bill appears to have improved chances for getting passed. The measure has garnered broad popular support, has the Bush Administration’s backing, and is supported by a majority of genetic counselors.
 

 
Qiagen Licenses RT-PCR IP From Roche, Ortho Clinical Diagnostics
 
Qiagen last week said it has licensed real-time PCR technology from Roche and from Ortho Clinical Diagnostics.
 
Under the agreement with Roche, Qiagen said it expands an existing arrangement to include all of Roche’s RT-PCR patents and pending patents. Qiagen said the agreement includes rights to patents for enzymes, improved PCR, and pathogen-specific patents.
 
Through the Ortho agreement, Qiagen has licensed rights to patents for a taq-polymerase antibody method that speeds up the activation of PCR enzymes in the early phases of the process.
 
Qiagen said that these licenses expand its portfolio of assays and diagnostics using “almost any” basic IVD-related PCR and real-time PCR.
 
Financial terms of the agreements were not released.
 

 
Clinical Data Fiscal Q3 Sales Up 20 Percent, R&D Spending Rises Nearly 80 Percent
 
Clinical Data’s fiscal third-quarter revenues increased 20 percent as R&D spending rose by nearly 80 percent, according to a preliminary earnings report last week.
  
CEO Drew Fromkin said the company has “begun to grow revenues in our genomics business,” and said it opened “important distribution channels in Europe and elsewhere” through agreements with several companies.  
 
The company recently launched a new PGxPredict test for Rituximab. Additionally, Clinical Data markets PGxPredict tests for warfarin and clozapine safety.
 
In the previous quarter, the company entered into an agreement with CVS’ PharmaCare, one of the nation’s largest pharmaceutical benefit managers, in an effort to “support Clinical Data’s commitment to introduce its therapeutic diagnostics into clinical care, with the goal of significantly reducing the cost of care while improving patient outcomes,” Fromkin said.
 
Total receipts for the three months ended Dec. 31, 2006, increased to $22 million from $18.4 million year over year.
 
R&D spending for the third quarter rose to $4.5 million from $2.5 million in the same quarter last year.
 
The company said net loss decreased to $6.3 million from $42.8 million in the year-ago period.
 
Looking forward, Fromkin said the company plans to push its Phase III trial for the antidepressant drug vilazodone, which last year Clinical Data said it will spin out into a separate business.
 

 
Newcastle University Awards Genotyping Project to Geneservice
 
Cambridge, UK-based Geneservice announced this week that it has been awarded a large genotyping project by Newcastle University’s Institute of Human Genetics for a study into vesicoureteric reflux.
 
Vesicoureteric reflux is a congenital condition that can lead to renal failure. Funded by the UK’s Medical Research Council, the project will genotype more than 1400 human samples from affected families in the UK and Slovenia, and is set to begin immediately.
 
Geneservice will perform initial amplification and quality checks of DNA samples using Affymetrix GeneChip Human Mapping arrays. The genotypes will then be used to perform a whole-genome linkage and association study, the company said.
 
Nick Leaves, operations director at Geneservice, highlighted in a statement that “the cost per genotype is very low because of recent price reductions by Affymetrix,” which “simply means the customer gets more great data for less money.”
 
Financial details of the award were not disclosed.

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