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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

China Medical Technologies reports revenues of US$25.2 million for third-quarter fiscal 2009

China Medical Technologies, Inc., a leading China-based advanced in-vitro diagnostic ("IVD") company, today announced its unaudited financial results for the third fiscal quarter ended December 31, 2009 ("3Q FY2009"). The Company's 2009 fiscal year ends on March 31, 2010 ("FY2009").

3 Mar 2010

Life Technologies to acquire AcroMetrix

Life Technologies Corporation, a provider of innovative life science solutions, today announced that it has signed a definitive agreement to acquire AcroMetrix, for an undisclosed amount.

12 Jan 2010

LehmanMillet honored with four prestigious industry awards

HealthSTAR's LehmanMillet, the leading agency devoted to working with health care companies changing standards of care, today announced it has won four prestigious industry awards: an MM&M (Medical Marketing & Media Magazine) Gold Award for work done on behalf of Abbott Nutrition; a First Place DxMA (Diagnostic Marketing Association) award for work done on behalf of Abbott Diagnostics; a First Place DxMA Award for work done on behalf of BRAHMS USA; and a PM360 Pharma Choice Bronze Award.

9 Jan 2010

BioPlex 2200 Anti-CCP test for early detection of RA launched

Bio-Rad Laboratories, Inc., a multinational manufacturer and distributor of life science research and clinical diagnostics products, and Axis-Shield plc, an international in-vitro diagnostics (IVD) company, today announced the launch of Bio-Rad's BioPlex® 2200 Anti-CCP test for the early detection of rheumatoid arthritis.

5 Jan 2010

Cepheid granted EUA for Xpert Flu A Panel test

Cepheid today announced it has been granted Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Xpert® Flu A Panel test.

4 Jan 2010

RPC declares 2010 business plans

Radient Pharmaceuticals Corporation, a US-based vertically integrated pharmaceutical company, whose wholly-owned subsidiary AMDL Diagnostics, Inc. (ADI) announced today it 2010 Business Plan. This forecast is based upon the Company raising at least $2 million during the first half of 2010.

23 Dec 2009

TessArae's RM-Flu test granted FDA EUA

TessArae, LLC, a privately held company, and Affymetrix Inc., (NASDAQ:AFFX) today announced that the Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to TessArae for its TessArray® Resequencing Influenza A Microarray Detection Panel for the Detection of the 2009 H1N1 Influenza A Virus (TessArray RM-Flu test) for the duration of the declaration of emergency unless revoked earlier. The declaration of emergency will expire on April 26, 2010, unless terminated earlier or renewed.

21 Dec 2009

KFDA approves RPC's Onko-Sure in Vitro Diagnostic cancer test

US-based pharmaceutical company Radient Pharmaceuticals Corporation (RPC) announced today the Korean Food & Drug Administration (KFDA) has approved RPC's Onko-Sure™ in Vitro Diagnostic cancer test for routine clinical testing and government reimbursement throughout Korea.

4 Dec 2009

AclarusDx Alzheimer’s test now available as RUO product

ExonHit Therapeutics is pleased to announce that AclarusDx™ Alzheimer’s test (formerly known as EHT Dx21), its blood-based test for the detection of Alzheimer’s disease (AD), is now available as a Research Use Only (RUO) product for pharmaceutical companies and leading academic centers conducting clinical trials in Alzheimer’s disease.

3 Dec 2009

Merck Chimie advances to the next phase in commercializing Beads, reports CardioGenics Holdings

CardioGenics Holdings Inc., a developer of technology and products targeting the immunoassay segment of the IVD testing market, reports that Merck Chimie S.A.S. ("Merck Chimie") is progressing to the next phase of the commercialization of CardioGenics' proprietary silver coated paramagnetic Beads ("Beads").

25 Nov 2009

EraGen Biosciences to have access to Illumina’s BeadXpress platform

EraGen Biosciences Inc., a developer of novel molecular reagents for the in-vitro diagnostics (IVD) market, and Illumina Inc., a global company that develops, manufactures and markets integrated systems for analysis of genetic variation and biological function, today announced the formation of a strategic partnership and the execution of non-exclusive licensing agreements.

From Illumina, Inc. 23 Nov 2009

Asuragen enters into an exclusive agreement with Life Technologies

Asuragen, Inc. announced today that it has entered into an exclusive agreement with Life Technologies Corporation to develop and distribute worldwide an in-vitro diagnostic test intended to aid clinicians in the monitoring and treatment of individuals afflicted with chronic myeloid leukemia (CML).

18 Nov 2009

Amorfix Life Sciences reports operating results for the three months ended September 30, 2009

Amorfix Life Sciences, a company focused on misfolded protein diseases, today reported its second quarter operating results and provided an update on the Company's diagnostic and therapeutic programs.

13 Nov 2009

BSI implements plans to expand its medical device Notified Body scope to include IVD devices

BSI, a world-class Notified Body providing regulatory and quality management reviews and product certification for medical devices, is rapidly implementing plans to expand its medical device Notified Body scope to include in vitro diagnostic (IVD) devices.

13 Nov 2009

"Point of Care Diagnostics 2010 and Beyond: Rapid Testing at a Crossroads" report from MarketResearch.com

MarketResearch.com has announced the addition of Kalorama Information's new report "Point of Care Diagnostics 2010 and Beyond: Rapid Testing at a Crossroads," to their collection of In Vitro Diagnostics market reports.

10 Nov 2009

China Medical Technologies to exhibit medical equipment from its three advanced IVD business lines

China Medical Technologies, Inc. (the "Company"), a leading China-based medical device company that develops, manufactures and markets advanced in-vitro diagnostic products, today announced that it will attend the 62nd China International Medical Equipment Fair ("CMEF") from October 28 to October 31, 2009 in Chengdu, China.

21 Oct 2009

ADI and CeTeCancer collaborate for research project

Radient Pharmaceuticals Corporation, a US-based pharmaceutical company, announced today it has entered into a collaboration agreement through its wholly owned subsidiary AMDL Diagnostics, Inc. (ADI) with CeTeCancer -- a Chilean-based research laboratory -- to validate the effectiveness of Radient Pharmaceuticals' Onko-Sure™ in vitro diagnostic (IVD) cancer test as an early detection and prevention test for lung cancer.

15 Oct 2009

Diagnostics industry in Asia Pacific poised to present more growth opportunities

The global diagnostics industry has witnessed strong growth over the past few years. According to Frost & Sullivan, the diagnostics and monitoring sectors are poised to present more growth opportunities. According to Nitin Naik, Vice President of Frost & Sullivan's Asia Pacific Medical Technologies Division, the diagnostics and monitoring sectors in Asia Pacific are projected to provide more growth opportunities on the basis of the technology spending being channelled in these areas (80 percent).

13 Oct 2009

The CE Marked HairDX Genetic Test for Hair Loss launched in Europe

The HairDX Genetic Test for Hair Loss, the world’s first genetic baldness (Androgenetic Alopecia) test, is now available as a CE Marked product under the European In Vitro Diagnostic Directive.

8 Oct 2009