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Archives for January 2013

WILEX and GeneDiagnostics Enter into Partnership for the IVD Approval and Distribution of the Serum HER-2/neu Test in China

WILEX AG (ISIN DE0006614720 / WL6 / Frankfurt Stock Exchange) recently announced that its US subsidiary WILEX Inc., Cambridge, MA, has entered into an exclusive distribution agreement with GeneDiagnostics Inc. for the commercialization of the serum HER-2/neu ELISA test in China. This biomarker test is FDA cleared in the USA, carries the CE mark for the European market, and is currently for Research Use Only in the Chinese market. GeneDiagnostics plans to conduct clinical studies in leading hospitals in China for the IVD clearance through the State Food and Drug Administration in China (SFDA) as part of the terms. GeneDiagnostics is a clinical research and service provider based in Hangzhou, China, and has well-established business relationships with major hospitals. Financial terms of the agreement were not disclosed.

SV Bio Launched as First Diagnostics Company to Provide Turnkey Translation of Comprehensive Genomics Data at Point of Care

Silicon Valley Biosystems (SV Bio), a diagnostics company founded to provide rapid, accurate, and turnkey clinical interpretation of comprehensive genomics data at the point of care to improve the health and outcomes of patients, was launched today. Backed by Sequoia Capital, a premier venture capital firm that helped to build Apple, Google, LinkedIn, Oracle and numerous biotech companies, SV Bio is ushering in the next phase of genomics-based medicine by providing clinicians with the tools they need to make faster, more precise and cost-saving decisions.

PerkinElmer Launches Automated Workstation for Improved Process Development of Protein Therapeutics

PerkinElmer, Inc., a global leader focused on improving the health and safety of people and the environment announced the launch of the JANUS® BioTx ProTM automated workstation for improved process development of protein therapeutics at the 12th Annual Protein Science Week (PepTalk), January 21–25 in Palm Springs, Florida at booth #312. Designed for high throughput, small scale protein purification, it is the only workstation that accommodates multiple chromatography modes (column, tip and batch) eliminating the need for multiple instruments, resulting in more efficient and cost effective sample processing.

Qiagen Submits Companion Diagnostic To Fda To Guide Treatment Decisions For New Investigational Lung Cancer Compound

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) recently announced submission of its therascreen® EGFR RGQ PCR Kit (therascreen EGFR test) to the U.S. Food and Drug Administration (FDA) as a proposed companion diagnostic to guide treatment with afatinib, a new investigational oncology compound developed by Boehringer Ingelheim. Afatinib has been accepted for filing and granted Priority Review by the FDA as a proposed treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with an epidermal growth factor receptor (EGFR) mutation detected by an FDA-approved test.

Congresswoman Barbara Lee Visits Tethys Bioscience

California Congresswoman Barbara Lee recently visited Emeryville-based Tethys Bioscience, developers of the PreDx® test, the predictive multi-biomarker blood test that differentiates adults with prediabetes according to their 5-year likelihood of progressing to type 2 diabetes, enabling clinicians to focus additional attention on those at highest imminent risk of disease conversion.