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IMD seeks FDA regulatory clearance for NADiA ProsVue prostate cancer prognostic test

IRIS International, Inc., a leading manufacturer of automated in-vitro diagnostics systems and consumables for use in hospitals and commercial laboratories worldwide, announced today that its IRIS Molecular Diagnostics (IMD) subsidiary has submitted a 510(k) pre-market notification application to the U.S. Food and Drug Administration (FDA) requesting regulatory clearance for NADiA®ProsVue™, a prostate cancer prognostic test. The test is designed to help physicians identify patients at low risk of cancer recurrence post radical prostatectomy.

29 Apr 2010

China Medical Technologies' AUTOMAGLIA 90 analyzer and Down Syndrome Screening receive SFDA approval

China Medical Technologies, Inc., a leading China-based advanced in-vitro diagnostic company, today announced that it received approval for its AUTOMAGLIA 90 fully-automated ECLIA analyzer as well as Down Syndrome screening kit from the State Food and Drug Administration of China.

29 Apr 2010

miacom diagnostics announces new tests for faster diagnosis of sepsis

"Conventional PCR tests (PCR is short for polymerase chain reaction, a highly sensitive method of detecting nucleic acids) require several hours to produce a result. lucesco Bacteremia IVD panels are not only much faster with a result after only 30 minutes, they are also much more cost-efficient.

29 Apr 2010

Life Technologies first-quarter non-GAAP 2010 revenue increases 13% to $887 million

Life Technologies Corporation today announced results for its first quarter ending March 31, 2010. Non-GAAP revenue for the first quarter was $887 million, an increase of 13 percent over the $785 million reported for the first quarter of 2009. Excluding the impact of currency and completed acquisitions and divestitures, organic revenue for the quarter grew 10 percent over the same period in the previous year.

28 Apr 2010

SQI Diagnostics signs development agreement with Silliker

SQI Diagnostics Inc., a medical systems automation company focused on evolving laboratory-based biomarker testing, today announced that it has entered into a development agreement with Silliker, Inc., a leading internationally accredited company dedicated to improving nutrition, food safety and quality, for the commercialization of a botulism toxin panel that will run on SQI's SQiDman analytical system.

26 Apr 2010

AdvaMed Dx welcomes Siemens Healthcare Diagnostics as association's newest member

AdvaMed Dx, a division of the Advanced Medical Technology Association focused on topics affecting the in vitro diagnostics industry, is pleased to welcome Siemens Healthcare Diagnostics as the association's newest member. Donal Quinn, chief executive officer of Siemens Healthcare Diagnostics, has been appointed to the AdvaMed Dx Board of Directors.

21 Apr 2010

IVAX Diagnostics signs two-year distribution agreement with Biomerica

IVAX Diagnostics, Inc., a fully integrated in vitro diagnostics company, and Biomerica, Inc., a global biomedical company, have signed a two-year agreement for the distribution of Biomerica's products in the U.S. and globally, with certain country and product exclusions.

13 Apr 2010

Diasorin migrates to Orange Business Services' Business VPN solution

Diasorin S.p.A., an international player in the market of in vitro diagnostics based in Saluggia (Vercelli, Italy), has migrated to Business VPN, a fully-managed, secure, global IP infrastructure from Orange Business Services connecting 12 locations in Europe, the Americas and Asia.

12 Apr 2010

Investment report on Radient Pharmaceuticals from StockPreacher.com

StockPreacher.com announces an investment report featuring Radient Pharmaceuticals Corp. The report includes financial, comparative and investment analyses, and industry information you need to know to make an educated investment decision.

9 Apr 2010

Biocartis closes Series 'B' equity financing round

Biocartis SA, a biotech company active in the field of personalized medicine and focused on fast, multiplexed and fully integrated molecular diagnostics based on its proprietary micro-technology and sample preparation platforms, today announced the successful closing of a Series B equity financing round. The Company raised EUR 30 million (~ USD 41.3 million) from its current shareholder base of leading life science investors and two new strategic investors from the pharmaceutical/diagnostic industry.

8 Apr 2010

Debiopharm Group, Biocartis sign investment agreement

Debiopharm Group, a Swiss-based global biopharmaceutical group of companies with a focus on the development of innovative prescription drugs that target unmet medical needs, and which has embarked in the field of companion diagnostics with a view to progressing in the area of personalized medicine, today announced the signature of an investment agreement with Biocartis.

8 Apr 2010

Cepheid to launch GeneXpert Infinity-48 in Europe at 20th ECCMID

Cepheid will initiate European launch of its newest addition to the GeneXpert® family of molecular diagnostic testing systems, the GeneXpert Infinity-48, at the 20th annual European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in Vienna, Austria. The GeneXpert Infinity-48 System is the world's first and only fully-automated, random-access system designed for management of the entire molecular testing workflow — from sample data, cartridge loading and unloading, to final reporting of test results and disposal of cartridges.

7 Apr 2010

IVAX Diagnostics reports net revenue of $4.5M for quarter ended December 31, 2009

IVAX Diagnostics, Inc., a fully integrated in vitro diagnostics company, reports its financial results for the fourth quarter and full year ended December 31, 2009.

31 Mar 2010

Life Technologies' real-time PCR instrument available for IVD use in Europe

Life Technologies Corporation (NASDAQ: LIFE) today announced that its Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument is available as a platform suitable for in vitro diagnostics (IVD) use in Europe. Clinical laboratories from 22 countries and European institutions that develop in vitro molecular diagnostic assays in oncology, genetic disease and infectious disease will now be able to leverage the instrument’s regulatory clearance to develop tests for clinical applications.

24 Mar 2010

Asuragen appoints BMD as exclusive distributor of Signature Oncology Products in France

Asuragen, Inc., a leader in the development of molecular diagnostics, announced today the appointment of Biomedical Diagnostics SA, a leading medical diagnostic company in Europe, as its exclusive distributor of Signature® Oncology Products in France. Asuragen’s Signature Oncology Portfolio comprises multiplex assays for the detection of mutations in solid and hematologic malignancies.

22 Mar 2010

Mini-laboratory: IVD platform to be presented at Analytica trade show

Many illnesses can be reliably diagnosed through laboratory tests, but these in vitro analyses often use up valuable time. A system developed by Fraunhofer research scientists, which can carry out complex analyses on the spot, will soon be ready for the market.

19 Mar 2010

Nova Century Scientific to market and sell Diamedix’ products in Canada

IVAX Diagnostics, Inc., a fully integrated global invitro diagnostics company, announced that its subsidiary, Diamedix Corporation, has signed a distribution agreement with Nova Century Scientific (“Nova”), a leading Canadian distributor and manufacturer of diagnostic kits and laboratory supplies. Through this agreement, which marks IVAX Diagnostics’ entry into the Canadian market, Nova will market and sell 50 of Diamedix’s products, including analyzer instrumentation, under the Diamedix brand.

16 Mar 2010

CardioGenics Holdings offers further update on Merck Chimie agreement status

CardioGenics Holdings Inc., a developer of technology and products targeting the IVD segment of the Point-Of-Care (POC) diagnostic market, announced today a further update regarding the status of its agreement with Merck Chimie s.a.s.

12 Mar 2010

Diamedix and Delta Biologicals’ suite of diagnostic tests: Fumouze Diagnostics to be exclusive distributor in France

IVAX Diagnostics, Inc., a fully integrated global in vitro diagnostics company, announced that Diamedix Corporation has signed a distribution agreement with Fumouze Diagnostics, a division of Sofibel S.A.S., of Paris, France, pursuant to which Fumouze Diagnostics will be the exclusive third party distributor of Diamedix Corporation and Delta Biologicals S.r.l.’s suite of diagnostic tests in France. Diamedix is a U.S. subsidiary of IVAX Diagnostics and Delta Biologicals is IVAX Diagnostics’ subsidiary located in Italy. The initial term of the distribution agreement is three years.

5 Mar 2010

Enigma Diagnostics opens new Regional HQ office in San Diego

Enigma Diagnostics Limited, the decentralised and point-of-care molecular diagnostics company, announced today the opening of its new Regional HQ office in San Diego, CA and the appointment of Joel Centeno as VP Regulatory & Quality.

4 Mar 2010