Roche Recalls COBAS TaqMan Analyzers for HBC, HCV in US
Fiber-optic malfunctions have caused Roche Molecular Systems to voluntarily recall its COBAS TaqMan Analyzers and COBAS TaqMan 48 Analyzers throughout the United States in labs that use the technologies to test for hepatitis B and hepatitis C viruses, as well as for other home-brew diagnostic testing.
“A few Analyzers have been found to have an improperly seated fiber optic cable, which potentially could result in falsely elevated patient test results,” Roche said in a letter to the US Food and Drug Administration July 22. “Falsely elevated results would suggest that the patient is not responding to treatment and the physician may stop or change therapy.
“In some cases this could result in progression of the disease and, due to the disease progression, ultimately lead to death,” Roche went on. “In extreme cases, the misalignment of the fiber optic cable could result in a mismatch of patient test results. RMS will continue to monitor instruments in the field to assess that fiber optic cables are correctly seated.”
Customers are told to call Roche at 1-800-526-1247.
The Swiss drugs and diagnostics company said it began investigating the faulty tests after it received “one customer complaint.” The firm said “no patient was inappropriately treated as a result of this situation.”
Roche told the FDA that it has notified customers, who “have had their instruments inspected … to assure proper alignment of the fiber optic cable.”
Read the full letter here.
Sequenom, NHGRI Expand Their Diabetes Collaboration
Sequenom and the National Human Genome Research Institute will perform allele-specific gene expression of genes that confer susceptibility to type 2 diabetes, building upon a previous research collaboration between the partners.
Under the three-year Cooperative Research and Development Agreement, researchers will use Sequenom’s MassArray Quantitate Gene Expression to conduct the study.
Sequenom and the NHGRI had previously collaborated on analyzing DNA for SNPs that correlate to type 2 diabetes. According to a release issued by San Diego-based Sequenom, the work builds upon research conducted by the NHGRI for the Finland-US Investigation of non-insulin dependent diabetes mellitus, or FUSION, project.
In April, Sequenom announced that its MassArray system had been used in the identification of a novel association between the HNF4A gene and type 2 diabetes (see 4/1/03 PGx Reporter). The results of that study, entitled “Genetic Variation Near the Hepatocyte Nuclear Factor-4A Gene Predicts Susceptibility to Type 2 Diabetes,” were published in the April 2004 issue of Diabetes.
It was conducted by a team from the US, UK, and Finland led by NHGRI director Francis Collins. The study was part of the FUSION project.
New NHGRI Web Site Focuses On US Genetic Laws, Policies
The National Human Genome Research Institute has unveiled a new web site that provides researchers, health professionals, and the general public with information on laws and policies related to genetic issues.
The site, which can be seen here, offers free and searchable information on genetic testing and counseling; insurance and employment discrimination; newborn screening; privacy of genetic information and confidentiality; informed consent; and commercialization and patenting.
The resource has an interactive map of the United States, enabling users to view pending legislation and laws for all 50 states and the District of Columbia. In addition to the federal and state laws, the database contains information from the Department of Health and Human Services, the Department of Health, Education, and Welfare, the Equal Employment Opportunity Commission, the US Patent and Trademark Office, the Secretary’s Advisory Committee on Genetics, Health, and Society, and the President’s Council on Bioethics.
Combimatrix Slated to Receive $2.3M in Defense Dept. Funding …
Combimatrix will receive $2.3 million from a US Department of Defense spending bill that was slated to be passed by Congress this week, the company said last week.
The funding will help the Acacia Research subsidiary develop a microarray-based biosensor system to monitor certain biological and chemical agents that could pose threats to national security. The system is being developed for testing in the field of combat as well as within the United States.
Combimatrix was originally awarded a $5.9 million contract in March by the DoD to develop this system. This new funding is for continued development of the system.
… and Posts Jump in Total Revenues Amid Narrowed Net Loss
CombiMatrix reported $750,000 in revenues for the second quarter, up from $6,000 in the same quarter of last year.
Revenues were down significantly compared to the first quarter, when the company recorded $17.6 million in revenues, $17.3 million of which were deferred revenues under a 15-year microarray development contract with Roche signed in 2001.
CombiMatrix, a Mukilteo, Wash., subsidiary of Acacia Research, recorded a net loss of $3.5 million, compared to $5.2 million in the same period of 2003.
R&D expenses were $2.1 million, compared to $2.2 million in the same period of 2003.
As of June 30, CombiMatrix had $28.9 million in cash, cash equivalents and short-term investments, compared to $17.3 million at the end of 2003. In April, Acacia Research raised $13.7 million in a stock sale of Acacia Research — CombiMatrix common stock, and attributed the proceeds to CombiMatrix.
Luminex Posts Increased Revenues, Narrowed Losses in Q2
Luminex said today that revenues for the second quarter of 2004 rose to $9.2 million from $5.6 million for the same period in 2003.
Meanwhile, net loss for the company in the second quarter dipped slightly to $1.1 million from $1.9 million in Q2 of 2003.
The company said that Q2 revenues consisted of $5.3 million from sales of 218 Luminex systems and $2.1 million from the sales of consumables. Year-to-date revenues have nearly doubled over last year, rising to $18.5 million in 2004 from $10.7 million for the corresponding period in 2003.
Luminex spent $987,000 on R&D in the second quarter of 2004 as compared to $881,000 for Q2 of 2003. As of June 30, the company had $54 million in cash and cash equivalents on hand.
Gene Logic Buys Drug Candidates from Millennium, Creates New Business unit
Gene Logic has licensed its ToxExpress database to Millennium, and has acquired two drug candidates as well as certain employees from the biotech company that will become part of a new business unit.
In return for $3.5 million in cash or stock and $1 million in payments to certain Millennium employees that will move to Gene Logic, GeneLogic will create a new research service to identify therapeutic indications for drugs.
The deal calls for Gaithersburg, Maryland-based Gene Logic to buy the development rights of Millennium’s obesity drug MLN4760. Gene Logic’s strategy, which it hopes to replicate in other deals, is to research new indications for the drug, and return it to Millennium’s pipeline if a successful compound is developed.
Gene Logic said it will spend at least $8.5 million over the next year and a half to develop and commercialize these technologies. Millennium will be the first customer for the new service.
The ToxExpress license is valued by Gene Logic at $4.5 million, according to the company.
Ipsogen to Offer Affymetrix- Based Research Services
Ipsogen will provide microarray-based services based on Affymetrix’s technology to industrial and academic customers, the companies said last week.
As an “authorized service provider” for Affymetrix technology, Ipsogen, based in Marseille, France, will add Affymetrix’s GeneChip system to its research services. The company’s services focus on the molecular diagnosis of cancer and cancer drug discovery and development.