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NanoString Technologies Receives FDA 510(k) Clearance for Prosigna Breast Cancer Prognostic Gene Signature Assay

NanoString Technologies, Inc., (NASDAQ: NSTG) a provider of life science tools for translational research and molecular diagnostic products, recently announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Prosigna™ Breast Cancer Prognostic Gene Signature Assay. Based on the PAM50 gene signature, Prosigna is the company’s first FDA-cleared in vitro diagnostic assay and uses the gene expression profile of cells found in breast cancer tissue to assess a patient’s risk of distant recurrence of disease. The Prosigna Assay is performed using the nCounter® Dx Analysis System, which can be placed in qualified laboratories throughout the United States, empowering oncologists and pathologists to quickly and easily meet the testing needs of their breast cancer patients.

“Receipt of FDA 510(k) clearance for Prosigna marks a key milestone for NanoString and is an important step forward in the treatment of breast cancer. This achievement is a testament to the ongoing dedication and professionalism of our team, and the commitment of our collaborators,” said Brad Gray, President and Chief Executive Officer of NanoString Technologies. “Prosigna illustrates our approach of using nCounter technology to translate genomic discoveries into powerful in vitro diagnostic products, and it represents a significant growth opportunity beyond our robust life sciences research business.”

The Prosigna Assay is intended for use as a prognostic indicator for distant recurrence-free survival at 10 years, and is indicated for postmenopausal women with Stage I/II lymph node-negative or Stage II lymph node-positive (one to three positive nodes) hormone receptor-positive breast cancer who have undergone surgery in conjunction with locoregional treatment consistent with standard of care. For each patient, the Prosigna Assay reports the Prosigna Score (referred to as Risk of Recurrence Score, or ROR Score, in the scientific literature, including the TransATAC study recently published in the Journal of Clinical Oncology ) and a risk category based on both the Prosigna Score and nodal status. Node-negative patients are classified as low, intermediate or high risk, while node-positive patients are classified as low or high risk.

Other key features of the Prosigna Breast Cancer Prognostic Gene Signature Assay include:

  • All-in-one assay consumables, including RNA extraction kits, allowing laboratories to test as little as a single section of formalin-fixed paraffin embedded (FFPE) tumor tissue
  • High-throughput workflow allowing each nCounter Dx Analysis System to process up to 30 patient samples per eight hour work day
  • Automated generation of personalized full-color patient reports that can be quickly and easily shared electronically with ordering oncologists

Bruce Seeley, Senior Vice President & General Manager of Diagnostics of NanoString Technologies commented: “We believe that the compelling clinical data, clear patient reporting, and unique delivery model position Prosigna for success in the U.S. market. By integrating the Prosigna Assay into existing laboratory workflows, we are offering physicians and patients seamless and timely access to clinical insights and a powerful tool that can aid in making more informed treatment decisions.”

Prosigna-enabled nCounter Dx Analysis Systems are expected to be available for placement in high-complexity Clinical Laboratory Improvement Amendments (CLIA) certified laboratories late in the fourth quarter of 2013. Prosigna testing services are expected to be available through qualified U.S. clinical laboratories beginning in the first quarter of 2014.

Source: NanoString Technologies

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.”

Rosetta Genomics Announces Acceptance for Publication of Kidney Cancer microRNA Diagnostic Manuscript by Molecular Oncology

Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics, recently announced that a manuscript regarding the development and validation of the Company’s microRNA-based diagnostic assay for the classification of renal cell tumors has been accepted for publication by Molecular Oncology. Yael Spector, a scientist from Rosetta Genomics, and Dr. Eddie Fridman , a pathologist and an expert in urological pathology from Sheba Medical Center in Tel-Hashomer, Israel, are the lead authors on the manuscript.

An unedited version of the manuscript is available online ahead of print publication of the final article at http://www.sciencedirect.com/science/article/pii/S157478911300046X.

The manuscript discusses the development and validation of the miRview® kidney assay, which differentiates between the four main types of primary kidney tumors: the three subtypes of renal cell carcinoma (RCC) namely clear cell, papillary and chromophobe RCC, and typically benign behaving oncocytoma. The assay was developed on a microarray platform using 181 training samples and validated on an independent set of 201 samples. The assay provided results for 92% of the validation samples, with 95% accuracy.

The topic of this manuscript will also be summarized in a poster to be presented on April 7 at the American Association for Cancer Research (AACR) Annual Meeting 2013 in Washington, D.C.

“There are an estimated 65,000 new cases of kidney cancer each year in the U.S. and more than 13,000 deaths. Distinguishing between the four main types of primary kidney tumors is critical in determining the optimal treatment regimen,” said Kenneth A.

Berlin , President and Chief Executive Officer of Rosetta Genomics. “Our miRview® kidney assay accurately classifies clear cell RCC, papillary RCC, chromophobe RCC and oncocytoma. We are delighted that this work has been accepted for publication in Molecular Oncology, an important industry trade journal.”

“The classification into subtypes of RCC has historically been less than definitive by histology, cytology and immunohistochemistry particularly in the growing context of fine needle aspirate (FNA) diagnostic specimens. The discrimination of the four subtypes can lead to the avoidance of aggressive surgical intervention in oncocytomas, and the others have differing biological behaviors that can be correlated with subtype. Importantly, newer therapeutic agents may show evidence of specificity of response by cell type. The expanded clarity of RCC diagnosis through the availability of this test will help lead to improved rationalization and optimization of new and emerging therapies, particularly in the community setting,” said Bob Wassman , M.D., Chief Medical Officer of Rosetta Genomics.

Source: PR Newswire

Luminex Receives FDA Clearance for First Comprehensive Gastrointestinal Pathogen Infectious Disease Diagnostic in the United States

Luminex Corporation (NASDAQ: LMNX) announced recently that it has received FDA clearance for its xTAG Gastrointestinal Pathogen Panel (GPP), the first comprehensive molecular diagnostic assay that tests for greater than 90% of bacterial, viral, and parasitic causes of infectious gastroenteritis in a single assay. The xTAG GPP assay can be an important clinical tool in the management of gastrointestinal infections, and is now available in the United States.

RiboMed Launches Improved Prognostic Multi Biomarker Epigenetic Test for Brain Cancer

RiboMed Clinical Services Laboratory (RCSL), a CLIA-certified subsidiary of RiboMed Biotechnologies, recently announced the release of a multi-marker methylation prognostic test for grading gliomas, the most common type of brain cancer. The test robustly analyzes 8 genes for differential methylation on FFPE (Formalin Fixed Paraffin Embedded) tumor samples to determine the G-CIMP (Glioma CpG Island Methylation Phenotype) score. The G-CIMP score correlates with patient survival and provides a new tool for physicians as they plan the patient’s treatment. This unique multiple DNA Methylation biomarker test, developed and validated by RCSL and commercialized and marketed by Castle Biosciences, Inc (Friendswood, TX), offers significant improvements in sensitivity, patient sample requirements and reproducibility over the bisulfite DNA methylation platform. These improvements were achieved by utilizing RiboMed’s proprietary and patented bisulfite-free Abscription®-based MethylMeter® platform.