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 will collaborate on a clinical trial assessing how individuals understand and use genetic information, the company said this week.
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. Navigenics first announced its plans for the genetic testing service, which will eventually also involve sequencing, last fall (see In Sequence 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 whole-genome sequencing service starts at $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 to 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 healthcare. 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."
Microchip Biotechnologies Gives Barcoding Center Early Access to Automated DNA Sequencing Sample Prep System
Microchip Biotechnologies said this week that it has started an early-access program for its Apollo 100 Star system, which it claims is the first fully automated and integrated system for preparing DNA for sequencing.
The first early-access user is the Canadian Center for DNA Barcoding at the Biodiversity Institute of Ontario at the University of Guelph.
The Apollo system uses MBI's microscale-on-chip-valve technology, which the company exclusively licenses from the University of California.
The instrument “automatically performs DNA cycle sequencing and bead-based cleanup on microchips which significantly reduces labor, costly reagent consumption, and potential errors in sample processing,” according to a company statement.
NTMir Funds McGill Researchers to Sequence Mycobacterium
NTM Info & Research said last week that it has awarded its first international research grant to the Research Institute of the McGill University Health Center to sequence the genome of Mycobacterium avium intracellulare.
This is the third study funded by NTMir under its Rapid Information Pilot Studies initiative, which addresses “pressing issues” regarding pulmonary NTM host vulnerability, sources of infection, and clinical treatment issues.
NTM Info & Research, a non-profit organization based in Miami, Fla., was founded in 2003 to support education and research for pulmonary nontuberculous mycobacterial lung disease.
NTMir did not disclose the funding amount in its announcement.
Eppendorf Files Patent Suits Against Bio-Rad
German laboratory equipment firm Eppendorf has filed two patent suits against Bio-Rad Laboratories over the last few weeks, according to court documents.
Last month, Eppendorf filed a suit against Bio-Rad in the US District Court, Northern District of California alleging that Bio-Rad and its MJ Research subsidiary has been selling or offering microtiter plates that infringe its US Patent No. 7,347,977, entitled “Microtitration Plate.” According to the complaint, Bio-Rad and MJ have been infringing the patent since as early as 2002.
Bio-Rad acquired MJ in 2004 for $47 million in cash plus legal liabilities.
Last July, Bio-Rad filed a lawsuit in a US District Court in Texas alleging that Eppendorf North America is infringing Bio-Rad’s US Patent No. 6,340,589, which covers the firm’s thin-well microplate. Bio-Rad asked the court for an injunction preventing Eppendorf from further sales of allegedly infringing products and an order for Eppendorf to pay triple damages for its alleged willful infringement.
Through the complaint filed last month, Eppendorf is seeking an injunction that would prevent Bio-Rad from selling its Hard Shell 96- and 384-well plates, as well as compensatory damages.
According to the court documents, the case has been referred to the Alternative Dispute Resolution Multi-Option Program.
Separately, Eppendorf filed an amended complaint against Bio-Rad and MJ earlier last week in the US District Court, Western District of Wisconsin for alleged infringement of its US Patent No. 6,767,512, entitled “Temperature-Regulating Block With Temperature-Regulating Devices.” Eppendorf claims that Bio-Rad and MJ have been infringing this patent through the sale of certain thermal cycler products.
Eppendorf is seeking an injunction and treble damages from Bio-Rad due to allegedly willful infringement.
ProGenTech Grabs $21M in Venture Financing from US, China Investors
ProGenTech said last week it has raised $21 million in a round of Series C financing led by Bay City Capital of San Francisco and DT Capital of Shanghai.
The company, which makes an automated nucleic acid extraction and purification system, has headquarters in Emeryville, Calif., and in Shanghai.
Earlier financing for ProGenTech came from angel investors. The Series C funding marks the company’s first round of financing from institutional venture capital firms.
Agilent Closes Purchase of German Photonics Company
Agilent Technologies said last week it has closed the acquisition of TILL Photonics, a developer and maker of optical and fluorescence microscopy products, for an undisclosed sum.
Agilent said the acquisition of the Munich, Germany-based company, which was founded in 1993 by a professor at the BioImaging Center of the University of Munich, will complement its atomic force microscope platform.
Agilent plans to add TILL Photonics to its Materials Science Solutions Unit, which is part of its Life Science and Chemical Analysis business.