A Medical Device Daily
Molecular diagnostics firm Epigenomics (Berlin), a developer of tests based on DNA methylation, confirmed that free-floating DNA gleaned from blood is a key to early detection of colorectal cancer.
Epigenomics showed that presence of the methylated form of DNA encoding the so-called Septin 9 gene is found in plasma of up to 57% of patients with all stages of colorectal cancer at high levels of specificity (95%). Data from the studies were presented at the 97th American Association for Cancer Research (Philadelphia) annual meeting in Washington.
“The presence of methylated Septin 9 DNA in blood is a marker suited as an excellent population screening tool to identify a large number of asymptomatic cancers,“ said Catherine Lofton-Day, PhD, vice president of molecular biology at Epigenomics. “Our study is the first of this magnitude and with this level of clinical performance to describe a DNA methylation-based blood test for the early detection of colorectal cancer. A blood-based screening assay will be more patient-friendly than the conventional colorectal cancer screening tool, which requires patients to collect and submit fecal samples for fecal occult blood testing – a considerable obstacle to patient compliance.“
The data presented come from two independent studies that determined Septin 9 levels in a total of 1,500 patients in three distinct categories. One group was known to be free from colon cancer after examination by colonoscopy. A second group included individuals with non-colorectal cancers and other non-cancerous conditions, and a third group consisted of patients with a confirmed diagnosis of colorectal cancer.
Epigenomics said it is continuing to identify and validate additional methylation markers for even better sensitivity in detecting colon cancer.
Baxa relocates sales, marketing
International healthcare product manufacturer Baxa Ltd . (Ascot, England), the UK subsidiary of Baxa (Englewood, Colorado), reported relocation of its sales and marketing operations to Bracknell, Berkshire, as of the end of April.
The new 10,000-square-foot facility includes demonstration rooms and enhanced training facilities for employees and customers. The company's sales, marketing, customer services, operations, finance, HR and quality departments will relocate to the new premises. Existing 5,000-square foot warehouse facilities in Ascot will continue to house the company's logistics and distribution activities.
The company said that its sales have tripled since 2000 and the move is “a result of continued sales expansion in the UK and across Europe.“
“Baxa Ltd. has consistently surpassed its sales targets and, as a result, has seen significant growth,“ said Terry Aston, managing director of Baxa Ltd. “Our staff numbers have doubled since 2002, and the existing premises do not have the capacity for further growth.“
Baxa develops technologies for fluid handling and delivery to promote the safe preparation, handling, packaging, and administration of fluid medications. Products include Rapid-Fill Automated Syringe Fillers, Exacta-Med Oral Dispensers, MicroFuse Syringe Infusers, Repeater Pharmacy Pumps, and Exacta-Mix and MicroMacro Multi-Source Compounders.
CombiMatrix wins European patent
Acacia Research (Newport Beach, California) reported that its CombiMatrix group was granted a key patent in Europe (EP1185363B1) titled “Self-Assembling Arrays.“ The patent was registered throughout the EU in Germany, France, Spain, Great Britain and Italy, and the opposition period has passed. A corresponding U.S. patent is pending and is moving through the process, according to the company.
The European patent claims both self-assembled arrays and a method for making self-assembled arrays on electrode arrays with self-assembled antibodies. This microarray configuration is especially useful for arraying proteins, specifically antibodies. The technology enables products such as multiplexed immunoassays, monitoring of biowarfare and terrorist agents, and general protein analysis tools.
“CombiMatrix's intellectual property strategy is designed to provide freedom to operate for CombiMatrix products as well as to establish strong barriers to protect the unique aspects and commercial advantages of our electrochemical synthesis and detection technologies,“ said Dr. Jeff Oster, senior vice president legal, at CombiMatrix. “In this case, we decided to wait the nine months after publication of the grant to let the opposition period expire before announcing.“
Acacia Research comprises two operating groups, Acacia Technologies and CombiMatrix .
Biosite, OGeS in blood test R&D accord
Biosite (San Diego) and privately-held Oxford Genome Sciences (OGeS; Oxford UK) said they are collaborating to evaluate protein-based disease markers for colorectal cancer for the development of blood-based tests. The tests would be aimed at providing, the companies said, “personalized“ therapeutic options for colorectal cancer. In particular, the blood-based diagnostics would enable early identification of colorectal cancer patients that have relapsed, thus enabling selection of the most appropriate appropriate therapies.
Today, the fecal occult blood test and colonoscopy, a highly invasive procedure, are the most frequently used screening and diagnostic methods for colorectal cancer, which has a 30% to 40% recurrence rate within an average of 18 months after first diagnosis.
OGeS has developed the Oxford Genome Anatomy Project (OGAP), a database that integrates genomic, proteomic and clinical information derived from blood and tissue studies. In the collaboration, OGeS will identify at least 25 proteins discovered in blood and tissue samples from relapsing colorectal cancer patients, with Biosite having the rights to develop blood-based tests using one or more of those biomarkers. Financial terms of the agreement were not disclosed.
“This collaboration expands our research aimed at evaluation of diagnostic tools for relapsing colorectal cancer by providing us with access to high quality validation of potentially valuable protein biomarkers,“ said Kim Blickenstaff, Biosite CEO.
Christian Rohlff, OGeS CEO, said, “Relapsing disease is the major cause of suffering and death in colorectal cancer patients and there is a complete lack of clinical tools to aid physicians in the process of deciding whom to treat when and whether to treat with chemotherapy.“
Patients with a primary diagnosis of colorectal cancer are followed up on average every three to six months for the first three years and every six months for the next two years to assess recurrence.