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FDA seeks public input on regulation of laboratory-developed tests

The U.S. Food and Drug Administration today announced plans to hold a public meeting on July 19-20, 2010, to discuss how the agency will oversee laboratory-developed tests (LDTs).

17 Jun 2010

Bayer receives silver Medical Design Excellence Award for CONTOUR USB blood glucose meter

Bayer's CONTOUR® USB meter, the first blood glucose monitor with unique plug & play diabetes management software, today received a silver Medical Design Excellence Award (MDEA). The MDEA recognizes excellence in medical product design and manufacturing. The independent judges for the prestigious award, sponsored by the specialist journal Medical Device and Diagnostic Industry, acknowledged the great innovative power and particularly user-friendly operation of Bayer's CONTOUR USB meter.

10 Jun 2010

SFDA approves China Medical Technologies' SPR-based HPV-DNA chip

China Medical Technologies, Inc., a leading China-based advanced in-vitro diagnostic company, today announced that it has received approval for its SPR-based HPV-DNA chip from the State Food and Drug Administration of China (the "SFDA").

10 Jun 2010

QuantRx Biomedical completes clinical testing of Q-Reader thyroid testing system

QuantRx Biomedical Corporation, a broad-based diagnostic company focused on the development and commercialization of innovative diagnostic products, today announced that it has completed clinical testing of the Q-Reader thyroid testing system.

9 Jun 2010

China Medical Technologies fourth-quarter revenues down 29.3% to $25.7 million

China Medical Technologies, Inc., a leading China-based advanced in-vitro diagnostic company, today announced its unaudited financial results for the fourth fiscal quarter and the full fiscal year ended March 31, 2010.

4 Jun 2010

CardioGenics Holdings announces further update on status of its agreement with Merck Chimie

CardioGenics Holdings Inc., developer of the ultra-sensitive QL Care™ Point-Of-Care analyzer and products for the immunoassay segment of the In-Vitro Diagnostics market, announced today a further update regarding the status of its agreement with Merck Chimie S.A.S., one of the largest manufacturers and distributors of magnetic beads for the diagnostics market.

28 May 2010

Berman Institute experts available for comment on direct-to-consumer marketing of genetic test kits

Journalists covering the recent announcement by Pathway Genomics that it will sell health-related genetic marker tests to consumers—and the subsequent decision by Walgreens to postpone sales of the kits pending clarification of their legal status—are invited to interview Berman Institute experts Joan Scott or Gail Javitt.

17 May 2010

IVAX Diagnostics first-quarter net revenues decline 1.4% to $4,655,000

IVAX Diagnostics, Inc., a fully integrated in vitro diagnostics company, reports its financial results for the quarter ended March 31, 2010.

14 May 2010

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

IVD News and Research

FDA seeks public input on regulation of laboratory-developed tests

Bayer receives silver Medical Design Excellence Award for CONTOUR USB blood glucose meter

SFDA approves China Medical Technologies' SPR-based HPV-DNA chip

QuantRx Biomedical completes clinical testing of Q-Reader thyroid testing system

China Medical Technologies fourth-quarter revenues down 29.3% to $25.7 million

CardioGenics Holdings announces further update on status of its agreement with Merck Chimie

Berman Institute experts available for comment on direct-to-consumer marketing of genetic test kits

IVAX Diagnostics first-quarter net revenues decline 1.4% to $4,655,000

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

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

miacom diagnostics announces new tests for faster diagnosis of sepsis

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

SQI Diagnostics signs development agreement with Silliker

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

IVAX Diagnostics signs two-year distribution agreement with Biomerica

Diasorin migrates to Orange Business Services' Business VPN solution

Investment report on Radient Pharmaceuticals from StockPreacher.com

Biocartis closes Series 'B' equity financing round

Debiopharm Group, Biocartis sign investment agreement

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

Exploring the intersection of biology and proteomics

Unlocking the Secrets of Multiple Sclerosis Progression: Brain-Immune Cell Communication

Passing on Polycystic Ovary Syndrome: Health risks for male offspring of women with PCOS

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