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Aseptika Awarded UK Patent for Home Test for Lung Infections

Aseptika recently announced that it has been granted a patent in the UK protecting its invention for a test for lung infections, designed to be used by patients at home and by clinicians at the bedside of patients in hospitals. With this new test, vulnerable patients with long-term conditions, such as Cystic Fibrosis (CF), Chronic Obstructive Pulmonary Disease (COPD) and Asthma, can keep a check on their health by measuring the activity of pathogenic bacteria in their lungs with a simple test using a sample of sputum.

Metabolon and Stemina Biomarker Discovery Settle Patent Dispute

Metabolon, Inc. and Stemina Biomarker Discovery, Inc. have entered into a licensing agreement and dismissed the patent litigation which was pending in the United States District Court, Western District of Wisconsin. Terms of the licensing agreement have not been released.

Elizabeth Donley, Chief Executive Officer of Stemina, said “We are happy to have reached an agreement with Metabolon and to have settled our differences in a way that allows both companies to move forward.” Donley stated she is focused on ongoing autism studies and raising money to accelerate the pace to market for Stemina’s blood test for autism as well as putting the final details together on a large contract with the United States Environmental Protection Agency.

“We are pleased to reach an agreement that brings our pending litigation to an end and further underscores the significant value of Metabolon’s technological innovations and Intellectual Property,” said John Ryals, CEO and President of Metabolon. Ryals continued, “Our focus continues to be the needs of our collaborators and the advancement of the metabolomics science for biomarker discovery, to uncover solutions in medical and nutritional research and the life sciences.”

Source: Business Wire

MolecularMD Corp. Obtains License to Commercialize Predictive Diagnostic Based on Actionable Biomarker, DDR2, for Uses in Lung Cancer and Targeted Kinase Therapy

MolecularMD Corp. recently announced that it has entered into a license agreement granting the company exclusive patent rights to cancer diagnosis technology. Specifically, MolecularMD has obtained rights to commercialize patent-pending intellectual property pertaining to DDR2 mutations for diagnostic, prognostic and predictive uses for humans in the area of lung cancer. Such patent rights are jointly-owned by The Broad Institute and Dana-Farber Cancer Institute. The inventors named on the patent are Drs. Matthew Meyerson, Peter Hammerman, and Alexis Ramos.

About DDR2 Mutations in Lung Cancer

Research into understanding the genetic basis of cancer has led to identification of novel biomarkers that have been successfully exploited with targeted therapies. In non-small cell lung cancer (NSCLC), several such targets have been discovered for adenocarcinoma including EGFR, ALK, and MET. Unfortunately, these therapeutic targets are not relevant for squamous cell carcinoma (SCC), which is the second most frequent histological subtype in NSCLC. Recent discoveries identified mutations in the discoidin domain receptor 2 (DDR2) of SCC patient tumors that are oncogenic and also responsive to existing drugs targeting kinase inhibition. DDR2 is a membrane receptor tyrosine kinase involved in cell adhesion, proliferation and migration. In xenograft models, DDR2-mutant tumors regressed under treatment with the tyrosine kinase inhibitor, dasatinib. Remarkably, an SCC patient with no detectable EGFR mutation had a long-term response to the combination of erlotinib plus dasatinib. This patient was found to harbor a DDR2 mutation further suggesting that DDR2 mutations may be clinically relevant. Given the availability of a variety of therapies targeting tyrosine kinases, these findings provide a rationale for designing clinical trials for patients with SCC using existing FDA-approved drugs such as dasatinib, imatinib, nilotinib and ponatinib as well as novel, selective tyrosine kinase inhibitors for DDR2.

MolecularMD is developing DDR2 diagnostic assays, including next-generation sequencing tests, for clinical trials exploring efficacy of targeted therapies and DDR2 clinical utility. MolecularMD provides comprehensive clinical trial support through its CLIA-certified and CAP-accredited Clinical Reference Laboratory. In addition, MolecularMD provides IVD development and manufacturing capability to support companion diagnostic device commercialization. MolecularMD will also support commercialization of DDR2 technology through sublicensing to clinical reference laboratories and diagnostic assay developers and manufacturers.

According to Dr. Greg Cox, MolecularMD’s Director of Licensing, “DDR2 is potentially the first actionable biomarker available for SCC patients, whose treatment options are currently limited to chemotherapy. It’s exciting that these patients may benefit from existing FDA-approved targeted therapies, and we are eager to support clinical trials examining these novel treatment possibilities and enable widespread access to DDR2 diagnostics.”

Cepheid And Oregon Health & Science University Collaborate To Develop Oncology Assays For GeneXpert® System

Cepheid (Nasdaq: CPHD) and the Knight Cancer Institute at Oregon Health & Science University (OHSU) recently announced a collaboration to develop a menu of advanced molecular diagnostics to be performed on the GeneXpert system.

The collaboration will focus on the development of clinical oncology tests for the GeneXpert system and will establish a system for clinically validating the tests through the Knight Diagnostic Laboratories, a division of the Knight Cancer Institute at OHSU. The alliance includes an exclusive license to OHSU intellectual property in prostate cancer and intellectual property co-developed by Lawrence Berkeley National Laboratory and OHSU in breast cancer.

The collaborative research will be led by Joe W. Gray, Ph.D., Associate Director of Translational Research for the Knight Cancer Institute at OHSU, and Michael Bates, M.D., Cepheid’s Vice President, Oncology Research & Development. Initial projects will focus on breast and prostate cancers, including development of Xpert(®) Breast Cancer Signature, a diagnostic test designed to predict the risk of recurrence in newly diagnosed patients, and Xpert Prostate Cancer Recurrence Risk, a test designed to predict the likelihood of recurrence in patients following surgery, as well as other prostate cancer applications. Each assay will take advantage of the GeneXpert system’s ability to quantitatively assess multiple RNA targets extracted from formalin-fixed, paraffin-embedded tumor tissue.

“Cepheid is honored to be working with Dr. Gray and his colleagues at OHSU with the goal of making their impressive scientific discoveries in the field of oncology and personalized medicine widely available to physicians for the benefit of their patients,” said David Persing, M.D., Ph.D., Cepheid’s Chief Medical and Technology Officer. “We look forward to partnering with OHSU to add a number of high impact oncology tests to the Xpert portfolio, delivering the most advanced diagnostic solutions for cancer patients while also achieving the accuracy, reproducibility, rapid turn-around-time, and cost-effectiveness that characterize the GeneXpert platform.”

“Forming an alliance with one of the world’s most innovative clinical test leaders represents an important opportunity for OHSU to explore how it can leverage its expertise in cancer and other disease research to develop more advanced diagnostic tools,” said J. Timothy Stout, M.D., Ph.D. and M.B.A., OHSU Vice President, Technology Transfer and Business Development. “We are particularly interested in Cepheid’s technology, because it makes sophisticated testing more cost efficient and allows for fast turnaround times, which can make a large difference in improving the delivery of health care.”

The collaboration’s first projects are focused on building upon research conducted at the Knight Cancer Institute to improve molecular testing to ensure patients receive the right treatment for their tumor’s biology – the primary goal of personalized cancer medicine.

“Prostate and breast cancer are the two most commonly occurring cancers in the United States and, together with Cepheid, we are determined to develop reliable, rapid and inexpensive diagnostic assays that are readily available to physicians and their patients,” said Gray, who is also Director of the OHSU Center for Spatial Systems Biomedicine. “As more information emerges about the molecular abnormalities that determine tumor behavior, we will be able to develop assays for the Xpert system that will allow us to identify and more precisely treat the most lethal forms of breast and prostate cancer, while sparing others from unnecessary treatments.”

The collaboration includes an option for the Knight Diagnostic Laboratories to develop Laboratory Developed Tests comprising the multiplexed gene expression signatures that will eventually appear on the GeneXpert system.

Source: Cephdid

Cell Signaling Technology Granted Patent for PCR Methods for Detection of a Subset of Treatable Non-Small Cell Lung Cancers

Cell Signaling Technology, Inc. (CST) of Danvers, MA, announced today the issuance of US Patent No. 8,288,102, relating to PCR-based methods for the detection of EML4-ALK (anaplastic lymphoma kinase) polynucleotides in patient samples. The presence of the fusion kinase EML4-ALK has been reported in a subset of patients with breast, colon, and non-small cell lung cancer (NSCLC). Pfizer’s XALKORI® (crizotinib) is approved in the US for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with ALK fusions as detected by an FDA-approved test.