Nanogen Replies to FDA; Pledges to 'Hear Them Out'
Nanogen has replied to an Aug. 12 warning letter from the US Food and Drug Administration and are "engaged in communications" with the FDA in order to resolve the situation, according to a company spokesperson.
The FDA requested that Nanogen respond within 30 days of receipt of the letter, which chided the firm for the way it has been marketing its 4-year-old NanoChip Molecular Biology Workstation calling the system "adulterated ... for failure to obtain pre-market approval and misbranded ... for failure to notify the agency of your intent to introduce the device into commercial distribution as required" by the FDA's 510(k) clearance" (see BAN 8/24/2005).
"Nanogen did reply in that time frame and so they are engaged in communications with the FDA and working towards hearing them out," a company spokesperson told BioArray News this week.
Nanogen disclosed that it had received the letter to the SEC last month. The company claims it has done nothing improper in marketing the workstation, but has pledged to resolve the issue.
Illumina to Provide Multi-Year Genotyping Services to GlaxoSmithKline
Illumina will provide further genotyping services for GlaxoSmithKline, the company said last week.
Under the multi-year agreement, Illumina will use its Sentrix arrays as well as its GoldenGate and Infinium assays to analyze several thousand samples provided by GSK, which are part of several projects. Illumina has already been providing genetic analyses for GSK since June 2001 (see BAN 7/6/2001).
Bill Craumer, head of corporate communications at Illumina, told BioArray News last week that he could not reveal the confidential contract terms, but that the new agreement would allow GSK and Illumina to participate in many studies. "Previous agreements were structured around a single study," Craumer said.
He added that the new agreement would give both Illumina and GSK "greater flexibility to begin new studies without engaging [each firm's] respective legal communities to review contract language."
Kreatech Says ISB Collaboration Will Result in New Labeling Kits
An ongoing collaboration between Kreatech Biotechnology and the Institute of Systems Biology will result in two new nucleic acid labeling kits, the Dutch company said last week.
ISB has optimized Kreatech's kits, which are based on its Universal Linkage System technology, for bacterial expression profiling and chromatin immunoprecipitation microarray (ChIP-on-chip) assays.
Brent Keller, Kreatech's vice president of commercial applications, told BioArray News last week that the company "will be coming out with ULS kits for these applications" based on the ISB collaboration. Keller did not provide a timeline for the commercial release of the new kits, however.
The company previously released kits for array comparative genome hybridization applications and gene-expression analysis.
Amsterdam-based Kreatech recently opened a US location in San Diego (see BAN 9/14/2005).
Sequenom Sells Two MassArray Systems
Each to Broad Institute, Sanger Institute
Sequenom has sold two of its MassArray Compact genotyping systems each to the Broad Institute of MIT and Harvard and to the Wellcome Trust Sanger Institute, the company said last week.
The sales resulted from positive beta test results of Sequenom's iPlex assays at the two institutions for various fine mapping projects, according
Researchers at the Broad used the iPlex assays for fine mapping and biomarker validation of an international consortium study on type 2 diabetes. At the Sanger Institute, scientists used the iPlex approach for follow-up studies to genome scans.
DiaGenic Awarded First Place at IPA
in Stockholm, Alzheimer's IVD on Track
DiaGenic, an Oslo, Norway-based diagnostics company, was awarded first place at the International Psychogeriatric Association's 12th Congress in Stockholm last week, according to a statement from the firm.
DiaGenic received the award for its presentation, entitled "Detection of Alzheimer's disease based on gene expression patterns in peripheral blood cells," which discussed the company's method of using peripheral blood samples to identify gene expression signatures that can be applied to detect Alzheimer's disease.
According to DiaGenic, researchers have identified a gene expression signature based on a panel of 33 genes that correctly predicted the diagnostic class in 34 out of 37 samples. In addition, a wider study, expected to be completed in early 2006, has been initiated using Applied Biosystems' microarray platform. The signatures validated and added during the collaboration with ABI will then form the basis for the development of a diagnostic test for Alzheimer's disease, DiaGenic said.
BioArray News spoke with representatives from DiaGenic about the ABI collaboration and the Alzheimer's Test last month (see BAN 8/17/2005).
Febit Biotech Picks Up OGT Microarray License
Oxford Gene Technology has granted a license for its microarray technology to Febit Biotech, according to a recent statement from OGT.
Febit Biotech manufactures and markets Geniom, a random access genomic analyzer. The company reorganized in April, 19 months after its predecessor company, also called Febit, filed for insolvency in Germany, where the firm is headquartered.
OGT manages the patent estate of microarray pioneer Sir Edwin Southern.
Genome Canada Awards $2.8M to
Atlantic Medical Genetics and Genome Initiative
Genome Canada will fund the Atlantic Medical Genetics and Genome Initiative, a Canadian disease genotyping project, with CA$3.2 million ($2.8 million), Genome Atlantic, a regional Genome Canada affiliate, said in a statement last week.
The initiative is a joint project that involves Memorial University and Dalhousie University, along with Genome Atlantic and the Atlantic Genome Center, the company said. The balance of the project's total funding of CA$9.2 ($7.9 million) will come from a "range of regional innovation and health research partners," Genome Atlantic said.
"Our research will pinpoint the genes that are the root causes of over 25 genetic diseases that affect Atlantic Canadians, and contribute to our overall understanding of the function of the 25,000 genes in the human genome," said Mark Samuels, a molecular researcher at Dalhousie University and co-principal investigator of AMGGI.
"This research will lead to improved methods for the early diagnosis of genetic diseases," including new genetic tests, said Pat Parfrey, clinical researcher at Memorial University and AMGGI investigator.