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Federation of American Societies for Experimental Biology, CS-Keys, HiFi DNA Tech, FDA, LabCorp, Affymetrix, DNAVision, Belgium Scientific Institute of Public Health, International Conference on Harmonization

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FASEB Urges Greater Federal Spending on Research in 2009
 
The Federation of American Societies for Experimental Biology has reiterated its request for Congress to increase funding for federal agencies and institutes that drive research in health and medicine, agriculture, biofuels, and other biology-based endeavors.
 
Despite the flat federal budget allocated to the National Institutes of Health in the recently passed 2008 budget bill, FASEB in its report, Federal Funding for Biomedical & Related Life Sciences Research, FY 2009, has asked for increased funding for the four primary agencies that support genomics and molecular biology.
 
The report recommends “what is necessary to reinvigorate and sustain our nation’s extraordinary research enterprise,” FASEB President Robert Palazzo said in a statement.
 
For FY 2009, FASEB recommends that the federal government allocate $31.2 billion to the National Institutes of Health, $7.33 billion for the National Science Foundation, $4.8 billion to the US Department of Energy’s Office of Science, and $1.38 billion for the Agricultural Research Service in the US Department of Agriculture.
 
The recommendation for funding the NIH gets the most attention in the report. Flat funding and rising biomedical inflation costs “has eroded the purchasing power of the agency” by roughly 13 percent, FASEB said, and “the United States is starting to lose ground to other nations” in almost every field of science and technology, from basic research to product development.
 
According to FASEB, 78 percent of Americans believe medical research is the best strategy for cutting healthcare costs, and 76 percent think it is “very important” that “the US remain a global leader in scientific research.”
 
The US faces emerging biological threats such as the MRSA, SARS, avian flu, and West Nile Virus, FASEB said in the report, and the aging of the US population will present other challenges, such as Alzheimer’s disease and osteoporosis.
 
The recently passed omnibus spending bill funds the NIH in fiscal 2008 with a total of $29.2 billion, which was around $800 million less than Congress had initially sought.
 

 
Indianapolis Biomarker Cancer Dx Firm Reels in $6.3M in Series A Funding
 
Indianapolis-based company CS-Keys has gained nearly $6.3 million in Series A financing from previous and new investors, the company said this week.
 
The cash infusion will fund the company’s initial product offering, the caPCNA Key Stain, a stain used to help pathologists detect the occurrence and re-occurrence of several types of cancer, including colorectal, breast, prostate, and ovarian cancers.
 
The financing round included investments from Triathlon Medical Ventures, which seeded the company; Clarian Health Ventures; Prolog Ventures; Ceres Venture Fund; and Spring Mill Venture Partners.
 
The company also is developing other biomarker-based diagnostics, including the caPCNA ELISA and caPCNA Cytology products.
 

 
HiFi DNA Wants FDA to Explain HPV Test Denial to a Judge
 
HiFi DNA Tech has filed a second lawsuit against the US Food and Drug Administration to get the agency to explain before a court its reasons for denying the company’s petition that it reclassify its molecular diagnostic test for human papillomavirus, the company said Monday.
 
The firm has been petitioning the FDA to lower its classification of the HPV DNA nested PCR Test from a Class III to a Class II device, on the basis that this test is a PCR-based genetic test similar to one that was used in the creation of the FDA-approved drug Gardasil, which is manufactured by Merck.
 
That petitioning included a lawsuit filed in October in Connecticut that was aimed at getting the FDA to review the petition and rule one way or the other, because the company said the agency had passed its deadline on issuing a decision.
 
The company said at the time that reclassification as a Class II device would enable it to file using the “less burdensome” 510(k) application to attempt to take its DNA test to market.
 
According to a Federal Food, Drug, and Cosmetic Act rule from the mid-1970s, “devices” are automatically classified as Class III until they are reviewed and graded otherwise. The FDA said in its denial letter to HiFi DNA that a Class III device is subject to premarket approval “to provide reasonable assurance of its safety and effectiveness.”
 
According to the FDA’s letter to HiFi DNA, the filing party must demonstrate that its device has “special controls … that would provide a reasonable assurance of the safety and effectiveness of your device.” These special controls are necessary if a device is to be used in “supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health,” according to the FDA.
 
But company President Sin Hang Lee said the FDA’s review was based on internal protocol and rules, and not on science. With this second lawsuit, HiFi is attempting to force the FDA to come before a judge and defend its scientific reasons for denying the company’s petition.
 

 
LabCorp to Use Affy Genotyping Tools for Cytogenetic Services; Plans to Buy CRO Tandem Labs
 
Laboratory Corporation of America will use Affymetrix’s genotyping tools in a molecular cytogenetic service it will offer to US researchers, Affy said this week.
 
Under the agreement, LabCorp will use Affy’s GeneChip technology in an offering that its customers can use to “correlate deletions, gains, and other chromosomal rearrangements with congenital diseases such as autism, mental retardation, and development delay in children,” the company said.
 
Using the GeneChip will allow LabCorp to offer researchers enhanced “resolution for the detection of the etiology of mental retardation, developmental delay, autism, and other clinically significant changes,” LabCorp Executive VP, CSO, and Medical Director Myla Lai-Goldman said in a statement.
 
Financial terms of the agreement were not released.
 
LabCorp also said last week that it will buy the pharmaceutical and biotechnology contract research services company Tandem Labs for an undisclosed sum.
 
Under the agreement, Burlington, NC-based LabCorp will buy all of the outstanding shares of Tandem Labs and its parent company, Northwest Toxicology. Tandem will retain its name and management structure and will operate as part of LabCorp’s Esoterix clinical trials group.
 
Tandem offers discovery, preclinical, and clinical drug development services and has around 54,000 square feet of lab space and over 30 LC/MS/MS instruments spread among its branches in Utah, New Jersey, and Massachusetts.
 

 
DNAVision Gains Belgian GLP for PGx, Tox Profiling
 
DNAVision has received Good Laboratory Practices compliance certification for its lab from the Belgium Scientific Institute of Public Health.
 
The certification covers the lab’s pharmacogenomic and toxicogenomic research services for medicinal compounds.
 
The Brussels-based company said last week that the clearance from the Belgian government makes it the first lab in Europe to receive clearance under GLP principles of the Organization for Economic Co-operation and Development and the European Union.
 
DNAVision, a spin-off from the University of Brussels’ Institute of Pathology and Genetics, offers SNP genotyping, sequencing, and expression profiling services.
 

 
International Group to Publish Guide of PGx Terms for Industry
 
The International Conference on Harmonization has finalized a set of definitions it will publish as a guideline in May that may be used by international scientists, companies, and regulators in assessing pharmacogenomics products and services.
 
The ICH is a joint effort led by the European Medicines Agency’s Committee for Medicinal Products for Human Use and includes the input of the US Food and Drug Administration.
 
The ICH has worked with regulators in Europe, North America, and Japan through a project called “Technical Requirements for Registration of Pharmaceuticals for Human Use” to develop definitions that will help facilitate the inclusion of pharmacogenomics and pharmacogenetics into drug development and approval processes.
 
The ICH started the project to remedy the inconsistency of applied definitions, which could lead to conflicting usage and interpretations by regulators, industry, investors, and ethics groups.
 
The ICH expects the definitions to be published without change in May, although it is still awaiting review from the FDA, the EMEA said through the ICH’s Secretariat office. The guideline defines pharmacogenomics, pharmacogenetics, genomic biomarkers, and other related terms.
 
According to the guideline:
  • Pharmacogenomics is “the study of variations of DNA and RNA characteristics as related to drug response.”
  • Pharmacogenetics, a sub-set of pharmacogenomics, is “the study of variations in DNA sequence as related to drug response.”
  • A genomic biomarker is defined as “a measurable DNA and/or RNA characteristic that is an indicator of normal biologic processes, pathogenic processes, and/or response to therapeutic or other interventions,” and could be a measurement of the expression of a gene, the function of a gene, or the regulation of a gene. A genomic biomarker may consist of DNA and/or RNA characteristics. 
  • DNA characteristics include SNPs, short sequence repeats, haplotypes, DNA methylation, SNP deletions or insertions, copy number variations, and rearrangements such as translocations, duplications, deletions, or inversions.
  • RNA characteristics include sequences, expression levels, and splicing, among others.
  • Genomic biomarkers are not limited to human samples, but may include samples from viruses and infectious agents as well as animal samples.
  • A drug should be considered synonymous with an investigational product, medicinal product, and medicine and pharmaceutical product, such as vaccines or other products.
  • The definitions of PGx and PGt do not include other disciplines such as proteomics and metabolomics.
  • Drug response will include the process of drug absorption and disposition, and drug effects, drug efficacy, and adverse effects of drugs.

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