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Ventana Receives Approval from China’s FDA for First Fully Automated IHC Companion Diagnostic Identifying ALK Protein Expression in Lung Cancer Patients

Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, recently announced the approval of the VENTANA ALK immunohistochemistry (IHC) assay by the Chinese Food and Drug Administration (CFDA) as a companion diagnostic to aid in the identification of patients for Pfizer’s CFDA-approved oncology product XALKORI® (crizotinib). The VENTANA ALK (D5F3) Rabbit Monoclonal Primary Antibody assay is designed to identify ALK-positive patients in non-small cell lung cancer (NSCLC) patients1. The approval is based on a retrospective study that included 1100 Chinese subjects across three national hospitals where the VENTANA assay demonstrated 99.23 percent concordance with Abbott’s Vysis ALK Break Apart FISH Probe Kit.

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.”

MicroConstants Expands Biomarker Testing and Analysis Services for Preclinical and Clinical Diagnostic Research

MicroConstants, a Contract Research Organization (CRO) specializing in regulated bioanalysis and DMPK, recently announced the appointment of Doinita Serban, Ph.D. as director of biomarker research to oversee the expansion of biomarker testing and analysis services for preclinical and clinical diagnostic research. Doinita’s extensive experience with biomarker assay development, validation, and profiling of disease panels, coupled with the implementation of the Luminex platform, will enable MicroConstants to broaden their biomarker analysis capabilities to include additional assay formats, such as multiplex immunoassays, gene expression and profiling assays.

Advances in Molecular Testing Offer New Hope for Lung Cancer Patients

The emergence of molecular diagnostic testing in lung cancer offers new hope for patients battling the number one cancer killer in the United States and abroad. Now, for the first time after a decade of biomarker testing in lung cancer, a uniform approach for testing for the EGFR mutation and ALK rearrangement along with the availability of targeted therapies offer lung cancer patients the chance for improved quality of life and more time with their loved ones.

The College of American Pathologists (CAP), the International Association for the Study of Lung Cancer (IASLC), and the Association for Molecular Pathology (AMP) have developed an evidence-based guideline, “Molecular Testing Guideline for the Selection of Lung Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitors,” which establishes recommendations for EGFR and ALK testing, helping to guide targeted therapies. The guideline was released on April 3, 2013, in Archives of Pathology & Laboratory Medicine (APLM), Journal of Thoracic Oncology, and The Journal of Molecular Diagnostics.

“The key recommendation of the guideline, and perhaps most important to lung cancer patients, is that all patients with advanced lung adenocarcinoma should be tested for EGFR and ALK abnormalities, that would qualify them for tyrosine kinase inhibitor therapy, regardless of their clinical variables, such as smoking history, gender, or ethnicity,” said Marc Ladanyi, MD, attending pathologist in the Molecular Diagnostics Service at Memorial Sloan-Kettering Cancer Center in New York, and IASLC member.

Similar to the testing done in breast cancer, matching a cancer patient’s molecular profile with the appropriate targeted therapy provides individualized treatment options. The guideline answers important clinical questions, including:

  • When should testing be performed?
  • How should testing be performed?
  • Should other genes be routinely tested in lung cancer?
  • How should molecular testing of lung cancer be implemented?

“In the U.S. up to 20 percent of patients with lung adenocarcinoma, the most common type of lung cancer, will test positive for one of the two biomarkers,” said Philip T. Cagle, MD, FCAP, medical director of Pulmonary Pathology in the Department of Pathology and Genomic Medicine at The Methodist Hospital in Houston, Texas, APLM editor, and CAP member. “It is critical to identify these patients because they stand to benefit more from new targeted drugs than from conventional chemotherapy, and with fewer side effects.”

For lung cancer survivor Richard Heimler, molecular diagnostic testing has meant five additional years with his family, including his daughter and son. After his initial diagnosis in 2004, Heimler had surgery to remove cancer tumors in his lungs and brain. When multiple tumors returned in 2008, Heimler participated in a clinical trial to determine if he was a candidate for targeted therapies.

“After testing positive for the abnormal ALK gene, I began taking a targeted drug in the form of a pill,” said Heimler. “It was wonderful to not experience the debilitating side effects that I had with chemotherapy. This new world of science has given me hope that I will have more time to create memories with my children and watch them grow up.”

In an era of precision medicine, the guideline provides recommendations for pathologists, oncologists, and other cancer health professionals on the current state-of-the-art recommendations for the molecular testing of lung cancer.

“The three organizations came together to address the variance in practice around the world about how this testing should performed,” said Neal I. Lindeman, MD, director of Molecular Diagnostics at Brigham and Women’s Hospital and associate professor of Pathology at Harvard Medical School in Boston, and AMP member. “Pathologists who specialize in molecular diagnostics and lung cancer collaborated to create the guideline to minimize variation and provide greater precision in the care of patients.”

The CAP Pathology & Laboratory Quality Center, (the Center,) a forum for developing evidence-based guidelines and consensus recommendations, provided the process for creating the guideline. Expert panels made up of renowned worldwide leaders in the field collaborated to develop the recommendations.

“The guideline is an important step in making sure that patients benefit from the new molecular understanding of lung cancer,” said Dr. Ladanyi. “As new studies lead to further evidence-based recommendations, we hope to develop additional guidelines for other biomarkers related to this disease.”

In conjunction with the publishing of the guideline, CAP, IASLC, and AMP have developed clinical tools and resources for pathologists and oncologists that summarize the findings and recommendations. In addition, the organizations have developed a patient guide for further understanding, including questions for patients to ask their physicians. A series of videos featuring three of the guideline authors and a lung cancer survivor can be found on the CAP, IASLC, and AMP YouTube Channels.

Source: EurekAlert!

Abbott to Collaborate with Janssen and Pharmacyclics on Development of Companion Test for Investigational Leukemia Therapy

Abbott (NYSE: ABT) recently announced that it will collaborate with Janssen Biotech, Inc. and Pharmacyclics, Inc. to explore the benefits of Abbott’s proprietary FISH (fluorescence in situ hybridization) technology for use in developing a molecular companion diagnostic test to identify patients with a genetic subtype of chronic lymphocytic leukemia (CLL), the most common form of adult leukemia.

Under the agreement, Abbott will develop a FISH-based test to identify high-risk CLL patients who have a deletion within a specific chromosome (chromosome 17p (del17p)) and may respond to ibrutinib, an oral, small molecule inhibitor of Bruton tyrosine kinase (BTK). Ibrutinib is currently in development by Janssen and Pharmacyclics for several B-cell malignancies, including chronic leukemia and lymphoma. Patients harboring a deletion within chromosome 17p are poor responders to chemoimmunotherapy and have limited treatment options. Having a test that is able to accurately detect the 17p deletion identifies a specific patient population with a high unmet medical need.

“Like Abbott’s other collaborations in the area of companion diagnostics, our goal is to leverage molecular technologies to help ensure that the right medicine is getting to the right person,” said John Coulter, vice president, Molecular Diagnostics, Abbott. “Cancer is a complex disease where, historically, therapies have demonstrated only a 25 percent efficacy rate. Companion diagnostic tests can help improve these outcomes by selecting patients that are more likely to respond to specific therapies, reducing time to the most effective treatment and increasing the number of positive outcomes.”

According to the American Society of Clinical Oncology (ASCO), future cancer therapies will be developed through molecular approaches that can accelerate development of more effective, personalized treatments. Identifying specific genetic characteristics of malignancies is expected to also support development of new treatments that target specific proteins involved in the development and growth of cancer.

In 2011, Abbott received U.S. Food and Drug Administration clearance for its Vysis CLL FISH Probe Kit. The kit targets multiple genes, including TP53 (tumor protein p53 gene, located on chromosome 17p) within the del17p region, and is used as an aid for determining prognosis for patients with CLL. Abbott’s Vysis CLL FISH Probe Kit will be used for investigational use only to determine genetic marker status as part of the co-development efforts between Janssen, Pharmacyclics and Abbott.

Source: Abbott