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Ignyta Announces CLIA Certification Achieved by its Diagnostic Laboratory

Ignyta, Inc. (Nasdaq: RXDX), a precision oncology biotechnology company, recently announced that its San Diego diagnostic laboratory successfully passed the State of California survey for CLIA (Clinical Laboratory Improvement Amendments) certification. The State of California inspector granted Ignyta permission to begin offering molecular diagnostic services to patients, including those in the company’s clinical trials.

Eutropics Laboratory Receives CLIA Certification

EUTROPICS Inc., a privately held company developing novel diagnostic tests that provide predictive insights to cancer patient response to treatment, recently announced its laboratory, located in Cambridge, MA, has received Clinical Laboratory Improvement Amendment (CLIA) certification from the U.S. Department of Health and Human Services’ Centers for Medicare and Medicaid Services (CMS) for its clinical diagnostics laboratory in Cambridge, Massachusetts. This certification follows receipt of a Massachusetts State license and allows the company to accept clinical samples from most U.S. states. The Milestone Clears the Path to Launch of PraediCare-Dx(TM).

Almac Offering TruSight Tumor Profiling Next-Generation Sequencing Service

Almac recently announced they are now offering a Tumor Profiling service running Illumina’s next-generation sequencing (NGS) TruSight Tumor™ panel as part of their biomarker discovery, development and delivery solutions.

Almac, a personalised medicine company with CAP accredited and CLIA certified laboratories, extends their portfolio of services by offering TruSight Tumor™ to complement its current range of RNA, DNA and protein based technologies for biomarker analysis.

Almac is currently running many bespoke diagnostic assays for pharma customers for early phase clinical trial enrichment. The TruSight Tumor™ panel enables additional profiling of these patient samples to provide Almac’s pharma partners with further important information on emerging biomarkers that may also impact drug response.
The TruSight Tumor™ panel was developed by Illumina for their MiSeq® system, allowing targeted DNA sequencing and reporting on the mutation status of 26 genes which are most commonly mutated in solid tumors including lung, colon, ovarian, melanoma and gastric cancers.

One of Almac’s key strengths is many years of experience in working with formalin fixed paraffin embedded (FFPE) tissue. The TruSight Tumor™ panel is specifically designed for use with FFPE samples, and enables the highest levels of sensitivity for mutation detection with limited DNA input requirements.

“Almac is committed to the development of personalised medicine through the delivery of a wide range of innovative solutions. We are pleased to announce the expansion of our NGS service to include TruSight Tumor™” said Professor Paul Harkin, President and Managing Director of Almac’s Diagnostic business unit.

Source: Almac

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

New Test for Cancer Researchers Targets Important Tumor-suppressor Protein

As researchers push to develop more customized diagnostics and therapies for solid tumor cancers, they demand increasingly sensitive tests that offer reliable, reproducible analysis. Spring Bioscience, Inc. (Spring) recently announced a new addition to its specialized portfolio of valuable antibodies for cancer research with the introduction of the Anti-PTEN (SP218) rabbit monoclonal immunohistochemistry (IHC) antibody.

PTEN is a common protein found in most tissues of the body. The protein acts as part of a critical cell signaling pathway that tells cells to stop dividing, helping to prevent uncontrolled cell growth that can lead to the formation of tumors. Mutations in the PTEN gene, together with other factors resulting in loss of PTEN protein, are a step in the development of many human cancers, including prostate and colon cancer. PTEN mutations are also believed to be the cause of a variety of inherited predispositions to cancer.

“With SP218, we’re seeking to set a new gold standard across the industry by offering an extremely sensitive, highly specific antibody optimized for IHC testing that will allow researchers and pathologists to interpret PTEN status with utmost confidence,” says Spring General Manager Michael Rivers. “For our customers, this means we’re continuing to offer unparalleled value through superior tests that lead the market in innovation, reliability and quality.”

Spring internal comparison studies demonstrated that SP218 provides more accurate, sensitive, and specific detection compared to similar research use only (RUO) tests on the market today.

Samples from more than 100 cases of primary prostate and colon cancer showed 100 percent concordance for PTEN loss among Spring’s SP218 and the leading commercially-available PTEN RUO tests; however, competitor tests exhibited some undesirable non-specific staining in IHC testing, while SP218 demonstrated highly specific staining in cells with and without PTEN expression.

“SP218’s robust and consistent performance with IHC analysis is particularly important given PTEN’s potential as a companion diagnostic biomarker,” adds Rivers. “Spring Bioscience is owned by Ventana Medical Systems, Inc., a member of the Roche group, and serves as an Antibody Center of Excellence for Roche’s companion diagnostics development to advance our goal for Personalized Healthcare.”

“Several pharma partners have embraced SP218 as their go-to antibody for PTEN IHC and are including it in their clinical trials as a potential companion diagnostic,” says Doug Ward, VP and Lifecycle Leader, Ventana Companion Diagnostics. “In addition, the Ventana Translational Diagnostics CAP/CLIA Laboratory is now using SP218 as their preferred RUO test for PTEN protein expression.”

Spring is known across the research industry for its quality development practices and for delivering a consistent supply of highly-specific antibodies. SP218 meets the company’s high standards as a valuable tool for assessing PTEN loss.

Source: Spring Bioscience