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QIAGEN announces formation of subsidiary in India

QIAGEN today announced the formation of its India subsidiary, QIAGEN India Pvt. Ltd., and the beginning of direct sales in the country. Until now, QIAGEN products have been sold in India through distributor partnerships.

From QIAGEN Manchester Limited 27 Jan 2011

IRIS International places 40 iQ200 Elite Automated Urine Microscopy Analyzers in Mexico in 2010

IRIS International, Inc., a leading manufacturer of automated in-vitro diagnostics systems and consumables, and a provider of high value personalized diagnostics testing services through its CLIA certified molecular diagnostics laboratory,has begun to significantly penetrate the Mexican healthcare market with the initial placement in 2010 of 40 iQ®200 Elite™ Automated Urine Microscopy Analyzers within one of the largest social security healthcare systems in Mexico.

25 Jan 2011

Study results of Pathwork Diagnostics's Tissue of Origin Test presented at ASCO 2011

Pathwork Diagnostics, Inc., a privately held molecular diagnostics company focused on oncology, announced today that results from a decision impact study of its Tissue of Origin Test were presented this weekend at the ASCO 2011 Gastrointestinal Cancers Symposium in San Francisco.

25 Jan 2011

Novartis enters definitive merger agreement to acquire Genoptix

Genoptix, announced today that it has entered into a definitive merger agreement to be acquired by Novartis. Under the terms of the merger agreement, Novartis will commence an all cash tender offer for all outstanding shares of common stock of Genoptix at USD$25.00 per share.

24 Jan 2011

IMDx enters multi-year agreement with Abbott Molecular for m2000 instrument system

IMDx today announced that they have signed a multi-year agreement with Abbott whereby IMDx will design, develop, regulatory clear, and manufacture assays for the Abbott Molecular FDA cleared, m2000 instrument system to be distributed worldwide. Financial terms have not been disclosed.

21 Jan 2011

Akonni introduces TruTip kit for extraction of human genomic DNA from fresh, frozen whole blood

Akonni Biosystems, a molecular diagnostics company focused on providing rapid and highly scalable solutions for infectious and genetic disease testing, today announced the launch of a TruTip kit for extraction of human genomic DNA from fresh or frozen whole blood.

20 Jan 2011

RG7204 Phase III study shows significant survival benefit in patients with metastatic melanoma

Genentech, a member of the Roche Group, today announced that BRIM3, a Phase III clinical study of RG7204, met its co-primary endpoints showing a significant survival benefit in people with previously untreated BRAF V600 mutation-positive metastatic melanoma.

19 Jan 2011

FDA clears Nanosphere's RV+ test for detection of respiratory viruses

Nanosphere, a leader in the development and commercialization of advanced molecular diagnostics systems, announced today FDA 510(k) clearance for the Verigene Respiratory Virus Plus Nucleic Acid Test on the Verigene System.

14 Jan 2011

Vermillion receives USPTO patent for PAD biomarker

Vermillion, Inc., a molecular diagnostics company, today announced that the United States Patent and Trademark Office has issued patent number 7,867,719 entitled "Beta-2 microglobulin as a biomarker for peripheral artery disease" to the Company.

12 Jan 2011

Caliper launches new LabChip Dx system for clinical research laboratories

Caliper Life Sciences, today announced the launch of Caliper's new, innovative LabChip Dx system for use by clinical research laboratories developing molecular diagnostic tests.

11 Jan 2011

QIAGEN to acquire minority stake in Alacris Theranostics

QIAGEN has signed an agreement for the acquisition of a strategic stake in Alacris Theranostics GmbH, a German start-up company using novel technologies to develop individualized cancer treatment strategies based upon a patient's genomic profile, and for the acquisition of an exclusive option to access all biomarkers emerging from this discovery program.

From QIAGEN Manchester Limited 11 Jan 2011

JMD publishes results of Tissue of Origin Test validation, reproducibility study

Pathwork Diagnostics, Inc., a privately held molecular diagnostics company focused on oncology, announced today that The Journal of Molecular Diagnostics has published the results of a significant Tissue of Origin Test validation and reproducibility study.

6 Jan 2011

IRIS ships 3,000th iQ200 Automated Urine Microscopy Analyzer to Sarasota Memorial Hospital

IRIS International, Inc., a leading manufacturer of automated in-vitro diagnostics systems and consumables for use in hospitals and commercial laboratories worldwide, and a provider of high value personalized diagnostics testing services through its CLIA certified molecular diagnostics laboratory, has shipped its 3,000th iQ200Automated Urine Microscopy Analyzer.

5 Jan 2011

GE Healthcare announces completion of tender offer for Clarient

GE Healthcare, a unit of General Electric Company announced today that it has completed the tender offer by GE's wholly owned subsidiary, Crane Merger Sub, Inc., for all outstanding shares of common and preferred stock of Clarient Inc., a leading player in the fast-growing molecular diagnostics sector. Clarient provides pathologists and oncologists with access to key diagnostic tests that shed light on the complex nature of various cancers.

23 Dec 2010

HistoRx grants Metamark worldwide license to AQUA technology for commercialization of Prognostic Assays

Metamark Genetics, Inc., a privately held oncology-focused molecular diagnostics company, and HistoRx, Inc., a diagnostics company developing tissue-based diagnostic solutions to advance individualized patient care, today announced a multi-year licensing agreement. HistoRx has granted Metamark a worldwide license to the AQUA technology for the clinical commercialization of Metamark's proprietary MetamarkDx™ Prognostic Assays.

20 Dec 2010

Spartan RX CYP2C19 DNA testing system receives European CE Mark certification

Spartan Bioscience Inc., a privately held molecular diagnostics company that develops, manufactures, and markets DNA testing systems for on-demand applications, today announced its Spartan RX CYP2C19 received a CE IVD Mark under the European Directive on In Vitro Diagnostic Medical Devices. The CE Mark certification allows commercial distribution in Europe as well as in all countries recognizing the CE Mark in the Middle East, Africa, Latin America, and Asia-Pacific regions.

20 Dec 2010

Akonni receives $150,000 Phase I NSF grant to assess feasibility of developing lab-on-a-film microarray device

Akonni Biosystems, a molecular diagnostics company that develops, manufactures, and plans to market sophisticated molecular testing devices for diagnosing infectious diseases and human genetic disorders, announced today the receipt of a $150,000 Phase I Grant from the National Science Foundation (NSF). This initial round of funding from NSF will enable Akonni to assess the feasibility of developing a lab-on-a-film microarray device that can be manufactured in a reel-to-reel format.

16 Dec 2010

ChipDX validates genetic signature for early-stage colon cancer

ChipDX LLC, a New York-based online molecular diagnostics and personalized medicine company, discovered and validated a genetic signature for early-stage colon cancer and is developing an online screening application to enable clinicians to more accurately identify risk of recurrence. In the study, published in the December issue of the British Journal of Cancer, ChipDX demonstrates how the 163-gene signature stratifies colon cancer patients into high- and low-risk groups for recurrence with greater accuracy than current methods.

8 Dec 2010

NanoString secures exclusive worldwide license to develop products for breast cancer intrinsic subtyping

NanoString Technologies, Inc., a privately held life sciences company marketing a complete solution for detecting and counting large sets of target molecules in biological samples, today announced it has secured an exclusive worldwide license from Bioclassifier, LLC to develop in vitro diagnostic and research products for breast cancer intrinsic subtyping.

From NanoString Technologies 7 Dec 2010

Asuragen, Novartis to develop ARQ BCR-ABL1 RNA IS Calibrators, laboratory software reporting tools

Asuragen, Inc. announced today that it has entered into an exclusive agreement with Novartis to develop worldwide Armored RNA Quant BCR-ABL1 RNA International Scale Calibrators and laboratory software reporting tools, intended to aid laboratories with standardization of BCR-ABL1 RT-qPCR testing to the International Scale. As part of this agreement, Asuragen will develop and, if successful, distribute the ARQ BCR-ABL1 IS RNA Calibrators and software reporting tools to laboratories globally directly or through its distributors.

6 Dec 2010