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Navigenics, Children’s Hospital of Philadelphia, Autism Genetic Resource Exchange, Asuragen, Codon Devices

Navigenics Developing Standards, Funding Research on Genetic Tests
Navigenics, which officially launched its genetic testing service this week, is developing a set of industry standards for consumer genetic testing and is set to collaborate on a clinical trial assessing how individuals understand and use genetic information, the company said.
The announcements come at the same time that the company officially launches its genotyping service, Navigenics Health Compass, which provides individuals with information about their genetic risk associated with 18 common conditions such as colon cancer, heart disease, and glaucoma. Reports about Navigenics’ genetic testing service first surfaced last September, when Affymetrix officials disclosed they were collaborating with Navigenics to develop the consumer genomics offering (see BAN 11/13/2007).
Navigenics’ service will compete with similar SNP-genotyping offerings from DeCode Genetics and 23andMe, as well as a whole-genome sequencing service offered by Knome. While Navigenics did not disclose pricing for the service in its announcement this week, it previously said that it would cost around $2,500. By comparison, the DeCodeMe and 23andMe offerings are in the neighborhood of $1,000, while Knome's sequencing service starts at around $350,000.
For the test, which will be offered directly to consumers, individuals provide Navigenics with a saliva sample from which DNA is extracted and tested using Affymetrix arrays. The company will then evaluate an individual’s genetic profile based on information in the scientific literature. The information will be made available online on an encrypted, password-protected site and individuals’ profiles will reportedly be updated as new information about the conditions they were tested for becomes available.
In the past few months, many have voiced concerns over individual privacy, the clinical relevance of various genetic tests, appropriate access to genetic counseling, and physician and patient education about the tests. In addition, the regulatory requirements surrounding these services remain unclear. 
Navigenics’ standards are intended to address such apprehension — and to provide new data about genetic testing outcomes. For instance, the company and the Mayo Clinic are funding a prospective clinical trial, scheduled to begin this month and continue through September 2009, which will address physician and patient understanding of genetic tests and their effects on preventative health decision making.
The company is also presenting a draft of standards to be applied to the genetic tests. Currently, the ten proposed standards include such criteria as validity, accuracy, and clinical relevance. They also address security and privacy issues, emphasizing an individual’s right to control who has access to their genetic information and the need to follow HIPAA regulations.
Navigenics said this week that it will present and solicit information about the standards at a meeting later this year organized in conjunction with the Personalized Medicine Coalition.
“The science is advancing at a rapid pace, and that’s very exciting not just for researchers, but for all of us who can ultimately benefit from the application of these findings,” Dietrich Stephan, co-founder and chief science officer of Navigenics, said in a statement. “But with that advancement comes a serious responsibility to ensure the integrity of this critical step towards personalized health care. We know that if we don’t do it right, we could set things back quite a bit — which is why it’s important for us and others to be clear about what we will be accountable for.”
The Redwood Shores, Calif.-based company is also touting itself as the only service currently providing access to genetic counseling. It is providing an on-staff certified genetic counselor to help interpret the genetic information and online information for consumers and physicians.
The firm also is highlighting the notion of using genetic information as a tool for preventative medicine. As such, it said it is focusing on conditions that are either preventable or which benefit from early detection and treatment. In addition, the company is providing information online for physicians and sponsoring a continuing medical education program through Medscape.
23andMe has also taken steps to address some of the regulatory uncertainty surrounding the consumer genomics market. Last week, the company's founders posted a notice informing customers that it had recently switched its service to a CLIA-certified lab because "the regulatory requirements we face are both complicated and uncertain."

CHOP Genotypes 4,500 Samples for Autism Genetics Research
The Children’s Hospital of Philadelphia said this week it has contributed a set of genotype data to the Autism Genetic Resource Exchange, or AGRE, which it gained through analyzing 4,500 samples AGRE had gathered.
CHOP's Center for Applied Genomics performed the genotyping with an Illumina HumanHap550 system.
The samples used in the analysis came from 4,500 individuals from around 900 families, including 1,250 children with autism spectrum disorders, their parents, and their siblings.
AGRE is a program of the organization Autism Speaks, which will make the genetic dataset accessible to researchers worldwide, CHOP said.
University of Pennsylvania researcher Maja Bucan, who is a collaborator on the project, said the high-density genotype data will provide novel insights into the genomic landscape of autism as well as other neurodevelopmental disorders.

Asuragen Launches miRNA Rx Spinout
Asuragen last week announced that it has spun out its microRNA-based therapeutics intellectual property into a new company called Mirna Therapeutics.
Specific details about the structure and focus of Mirna were not disclosed.
“The discovery of miRNAs represents a paradigm-changing event in biology and medicine of a magnitude that only occurs once every decade or two," Asuragen CEO and CSO Matt Winkler said in a statement. “They likely will become a major new class of drugs.”
As reported by BioArray News sister publication RNAi News in January, the new company is initially being funded with $3 million from Asuragen.

Codon Raises Additional $11M in Series B Venture Capital Financing
Codon Devices has reeled in $11 million in additional funding from a Series B financing with existing investors, bringing its total funding for the round to $31 million, the company said last week.
Codon said that all of its existing investors, including Alloy Ventures, Flagship Ventures, Highland Capital Partners, Khosla Ventures, Kleiner Perkins Caufield & Byers, and Tactics II Ventures, contributed to the most recent investment.
Codon plans to use the funds to expand its gene synthesis and protein engineering capabilities, to expand its commercial synthetic biology applications, and to develop its international commercial presence.
Codon markets its synthetic biology products and design services, including its BioFab production platform, to clients in the pharmaceutical, biotechnology, institutional, and bioenergy fields. The BioFab platform combines informatics and proprietary algorithms, automated technology, and biochemical protocols for use in designing and building genetic sequences.
The firm is being sued by Febit for patent infringement (see BAN 7/17/2007).

The Scan

Positive Framing of Genetic Studies Can Spark Mistrust Among Underrepresented Groups

Researchers in Human Genetics and Genomics Advances report that how researchers describe genomic studies may alienate potential participants.

Small Study of Gene Editing to Treat Sickle Cell Disease

In a Novartis-sponsored study in the New England Journal of Medicine, researchers found that a CRISPR-Cas9-based treatment targeting promoters of genes encoding fetal hemoglobin could reduce disease symptoms.

Gut Microbiome Changes Appear in Infants Before They Develop Eczema, Study Finds

Researchers report in mSystems that infants experienced an enrichment in Clostridium sensu stricto 1 and Finegoldia and a depletion of Bacteroides before developing eczema.

Acute Myeloid Leukemia Treatment Specificity Enhanced With Stem Cell Editing

A study in Nature suggests epitope editing in donor stem cells prior to bone marrow transplants can stave off toxicity when targeting acute myeloid leukemia with immunotherapy.