Affymetrix Licenses Array IP to Baylor for CLIA-based CGH Services
Baylor College of Medicine has licensed a number of patents from Affymetrix to perform certain microarray services in Clinical Laboratory Improvement Amendments environments, the groups said this week.
Under the terms of the deal, scientists at Baylor’s Department of Molecular and Human Genetics will have non-exclusive rights to use Affy’s patents for comparative genomic hybridization microarray services.
Arthur Beaudet, chair of Baylor’s DMHG, said the scientists will use the technology “to identify specific genetic abnormalities in many children that have developmental disabilities with previously unknown causes.”
The DMHG conducts research in a wide variety of fields, including functional genomics, sequencing, human and mammal genome studies, and numerous diseases.
Financial details or the duration of the agreement were not disclosed.
Invitrogen Closes $26M Sentigen Acquisition
Invitrogen said this week it has closed its acquisition of Sentigen Holding.
The $25.9 million cash deal was announced in September.
Invitrogen paid $3.37 per share for the Phillipsburg, NJ-based company, which will become part of Invitrogen’s Discovery Sciences division, located in Madison, Wis.
With the acquisition, Invitrogen picks up Sentigen’s Tango assay system for protein interaction and GPCR screening and its assay ready cells that pare down the assay process, the company said.
At close of the business day Dec. 1, Sentigen had $11 million in cash and cash investments, the company said. On the trading day following the closing of the acquisition Sentigen shares were trading at $3.40.
Celera Genomics Changes Name to Celera
Celera Genomics has been renamed Celera, according to a Securities and Exchange Commission filing late last month.
The Applera unit will be formally called Celera Group. It had been known as Celera Genomics Group.
Shareholders approved the name change at the firm’s annual investor conference on Oct. 19. It became effective Dec. 1.
Celera will continue to trade on the New York Stock Exchange under the “CRA” ticker symbol. Stockholders will not be required to change out their share certificates.
Geospiza Closes $3M in Financing
Geospiza said this week it has completed a $3 million round of series A stock financing.
Geospiza, which sells genomic data-management software, said it intends to use the funds to add product and sales staff to meet increasing demand.
The company said it will also use the funds to further expand a collaboration with Applied Biosystems that the companies began in 2005 and expanded in August.
Geospiza said that the development of new tests for cancer and infectious disease is driving demand for its software, and that its customers are seeing increased pressure to "streamline their analytical procedures and reduce testing backlog."
CDC Dishes Out $11.4M to Nanogen, Cepheid, Two Others Developing Portable Flu Dxs
The US Centers for Disease Control and Prevention has awarded $11.4 million to Cepheid, Nanogen, and two other companies developing “quick” and “accurate” field-deployable tests to diagnose H5N1 avian flu and other influenza viruses, the CDC said this week.
The CDC said it intends to work with the US Food and Drug Administration to help tests developed from the program to receive FDA clearance and be ready for commercialization “within two to three years.”
Nanogen pocketed $4.5 million to develop “a novel point of care immunoassay system.” In its own statement, Cepheid said its award covers phases one and two of a five-phase, 30-month program.
Nanogen said it will use the cash to develop a third-generation lateral flow immunoassay that will cost about the same as other POC tests on the market. If the CDC continues funding Nanogen through phases three through five, the entire project value for the company could total $12.5 million.
Cepheid has won $2.4 million to develop flu assays on its GeneXPert platform. The company said it has been contracted to develop an automated test for use on the GeneXpert system using real-time PCR, which will not require specific expertise or specialized training.
The two other companies include Iquum, based in Marlborough, Mass., which received $3.8 million to develop a lab-in-a-tube system, and MesoScale, of Gaithersburg, Md., which won $706, 241 to develop its multi-array detection system.
The $3.8 million Iquum received for phases one and two will be used to develop nucleic acid tests based on its lab-in-a-tube technology that will differentiate H5N1 from other flu viruses. Iquum did not say whether it expects to be contracted for the later phases of the project.
The CDC said it hopes to work with the companies over the coming year to create point-of-care tests that can detect and differentiate various flu viruses, including avian H5N1, in 30 minutes.
These tests would need to be easily adaptable to account for the ability of certain viruses to rapidly mutate, and to be ready for the swift emergence of unknown ones, the CDC said.
In a statement, CDC Director Julie Gerberding said the center hopes the contracts generate “promising technology that could help doctors treat their patients faster and help public health authorities track influenza viruses that could spur a pandemic."
Correlagen Offers Test to Detect Early Heart Attack Risk
Correlagen Diagnostics and the healthcare information technology supplier Cerner will conduct a pilot program in 2007 to evaluate the health and economic benefits of using a genetic test in the treatment of familial hypercholesterolemia.
Patients enrolled in the pilot program will utilize Correlagen’s LDLR (low density lipoprotein receptor) gene test, which can identify a mutation in family members who may not have abnormal cholesterol levels.
According to the company, 600,000 Americans, some as young as 21 years old, have a genetic cause of high cholesterol, familial hypercholesterolemia, which increases their risk of suffering heart attacks by 125 fold. Early detection is critical for the survival of FH patients. Genetic testing for LDLR mutations may allow families to determine early who is at risk.
“With proper diagnosis and treatment, using a combination of targeted genetic testing and cholesterol-lowering drug therapy, heart attacks could be prevented in 200,000, and deaths in 50,000, of these individuals,” Correlagen said in a statement.
The Netherlands and Norway have implemented nationwide FH genetic cascade-screening programs. Similar programs are also in place in Denmark, France, the Czech Republic, Italy, and Spain. These programs outside the US show that family-based testing for FH leads to better treatment and fewer deaths from heart attack, Correlagen said.
Cerner is particularly interested in the potential cost savings that may result from incorporating Correlagen’s predictive genetic tests in FH therapy. "The potentially life-saving information that can result from Correlagen's LDLR test fits with Cerner's broader initiatives to include predictive science into health benefits,” Cerner said in a statement.
Physicians may order the LDLR Sequencing Test directly from Correlagen Diagnostics.
Pfizer Stops All Torcetrapib Clinical Trials Due to Increased Mortality Risk
Pfizer notified FDA last week that it will suspend a large, Phase III trial for the investigational cardiovascular therapy torceptrapib/atorvastatin (T/A) due to an increased rate of mortality in patients receiving the combination compared to those receiving atorvastatin (Lipitor) alone.
An independent Data Safety Monitoring Board discovered the increased mortality risk during its monthly analysis of the data and its quarterly analysis of a number of outcomes including stroke, heart attack, and revascularizations. The DSMB notified Pfizer of its finding on Dec. 2, and FDA was notified the same day. Pfizer said it will halt this trial and T/A's development program overall.
The news of the mortality data follows Pfizer's R&D day in Groton, Conn., last week, during which the company presented numerous clinical trials evaluating the T/A combination. Clearly, Pfizer had pinned significant hopes in the clinical success of the combination therapy.
One particular study, which will now be stopped, was looking at the efficacy and safety of T/A versus atorvastatin alone in patients with heterozygous familial hypercholesterolemia, who have a primary defect in the LDL receptor gene, elevated LDL-C, and an increased risk of premature cardiovascular disease.
"FDA fully supports Pfizer's decision to suspend this trial. The system of biomedical research monitoring was effective in this case, assuring that once a certain signal was seen, the trial was halted," the agency said in a statement. "FDA will continue to work with Pfizer and other sponsors developing molecules in this class of drugs to ensure that appropriate protections are in place to identify any safety signals as early in the development process as possible."