A Medical Device Daily

Sequenom (San Diego) reported an exclusive worldwide licensing agreement with Optherion (New Haven, Connecticut). Sequenom's CAP accredited and CLIA-certified laboratory, Sequenom Center for Molecular Medicine (Sequenom CMM), obtained the rights to develop and commercialize diagnostic tests to predict genetic predisposition to late stage age-related macular degeneration (AMD).

The license agreement covers extensive intellectual property rights for the most significant AMD-related genetic variants that have been confirmed in multiple clinical studies around the world. The portfolio of intellectual property being licensed has been consolidated from major U.S. universities that have spearheaded genetic and clinical AMD research during the last decade, the company noted.

Upon successful development of the test, Sequenom CMM intends to market a laboratory-developed test under its SensiGene brand name for genetic tests. The laboratory anticipates launching the new test early next year.

"This opportunity is an excellent fit for Sequenom," said Ronald Lindsay, PhD, senior VP of R&D at Sequenom. "The format of the assay that we plan to develop is optimal for our MassARRAY technology. Indeed, our platform has already been used in several of the key published studies that have firmly validated the link between AMD and the genetic variants that we expect to form the basis of our planned test. The addition of this licensed technology to our portfolio is an important step toward our aspiration to develop and commercialize a portfolio of meaningful proprietary genetic tests driven by unmet clinical needs."

"The licensing agreement with Sequenom adds significantly to our ability to push forward in developing both diagnostics and ultimately disease-modifying treatments for dry AMD," said Colin Foster, president/CEO of Optherion.

"Given the demographics of an aging U.S. population driving an increased incidence of AMD, the ability to assess the genetic risk of disease progression will not only help steer our current management strategies, but also accelerate the development of novel genetically guided therapeutics that could drastically reduce, or even eliminate, the devastating loss of vision that accompanies AMD," said Michael Tolentino, MD, Center for Retina and Macular Disease (Winter Haven, Florida). "Genetic information may also predict response to currently available therapies and may be useful in classifying patients who will respond favorably or unfavorably to current treatments for wet AMD."

About 75% of disease risk is inherited and predominantly caused by variations in a handful of genes discovered over the last five years. Most of the affected genes have been identified in regulatory proteins contained within the alternative complement system involved in innate immunity. Sequenom's goal is to develop a simple non-invasive DNA test to be performed once that will provide a clinician with genetic information specific to an individual's risk of progression to late stage CNV in order to optimize patient management to preserve vision.

A patient's knowledge about being at higher risk also makes it easier to take certain preventative steps such as no longer smoking, and switching to a healthier diet rich in vitamins, antioxidants, certain carotenoids, and omega-3 fatty acids. Smoking and diet are among the most important modifiable risk factors that have been proven in clinical studies to delay onset and progression of late stage disease, according to Sequenom.

In other dealmaking activity:

• Volcano (San Diego) said it has acquired the Xtract Thrombus Aspiration Catheter device line from Lumen Biomedical (Maple Grove, Minnesota). Volcano became the exclusive global distributor of the Xtract catheter in May. This acquisition reinforces Volcano's dedication to build a strategic portfolio of diagnostic and therapeutic tools to help patients with coronary artery disease at all levels of complexity, including acute myocardial infarction, or heart attacks, the company said.

The Xtract thrombus aspiration catheter supports the care of ST Segment Elevation Myocardial Infarction. The Xtract aspiration catheter, with its large single lumen design, circular right-angle tip, and curved directional distal segment, delivers fast and powerful clot removal to help re-establish blood flow quickly, the company said. The product line includes two sizes, with the larger size model offering the largest aspiration lumen of any aspiration catheter, for effective and efficient clot extractions.

• Qiagen (Venlo, the Netherlands) said its subsidiary DxS (Manchester, UK) has acquired the global and exclusive license for biomarker PI3K from Johns Hopkins University (Baltimore) to develop real-time-PCR and endpoint PCR assays. Research has shown that variation in the PI3K gene could be a key biomarker for use as a companion diagnostic with certain cancer treatments. The studies suggest that mutations in the PI3K oncogene are predictive for the success of certain treatments of patients suffering from lung, breast, colorectal and other cancers. Qiagen has an active PI3K assay development and partnering program with pharmaceutical companies to develop and market tests for new cancer drug candidates. Financial details were not disclosed.

Qiagen already markets a PI3K test for research use. This test is based on real-time polymerase chain reaction (RT-PCR), a widely available technology to make DNA sequences visible through amplification. The assay, which uses technology that allows a very significant sensitivity, detects mutations frequently missed by sequencing methods.

The patent for PI3K mutations in human cancers was initially filed by researchers at Johns Hopkins who assessed the biomarker during their evaluation of tyrosine kinase inhibitors targeting the epidermal growth factor receptor (EGFR) pathway. Various EGFR inhibiting drugs have shown to be not effective in cancer patients with mutations in genes of the EGFR pathway (EGFR, K-RAS, B-RAF, etc). Qiagen already markets several tests determining the mutation status in oncogenes. This portfolio includes tests for mutations of K-RAS and B-RAF, which are indicative for metastatic colorectal, lung and other cancers. The K-RAS test is CE-marked for companion diagnostic use with EGFR inhibitors Vectibix and Erbitux and is expected to be submitted for FDA approval soon, the company noted.