In Vitro Diagnostics News and Research

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Accuri Cytometers announces completion of $6 million Series E preferred stock financing

Accuri Cytometers, Inc., a world leader in providing life science researchers with easy-to-use, cost-effective flow cytometers, today announced completion of a $6 million Series E preferred stock financing. The financing included current investors Arboretum Ventures, Baird Venture Partners, Fidelity Biosciences, Flagship Ventures and the InvestMichigan! Program co-managed by Credit Suisse.

12 Jul 2010

IRIS submits 510(k) application for clearance of iChemVELOCITY and iRICELL Urinalysis Workstation

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 Diagnostics Division submitted on June 30, 2010, a 510(k) pre-market notification application to the U.S. Food and Drug Administration (FDA) requesting regulatory clearance for its iChem®Velocity™ Automated Urine Chemistry Analyzer and iRICELL® Urinalysis Workstation.

1 Jul 2010

Signature Dx obtains worldwide license to Affymetrix microarray technology for development of CRC tests

Affymetrix, Inc. and Signature Diagnostics AG today announced that they have signed a Powered by Affymetrix™ (PbA) agreement. Under the agreement, Signature Dx obtains a worldwide license to use Affymetrix® microarray technology to develop and commercialize diagnostic and prognostic colorectal cancer (CRC) tests.

29 Jun 2010

AMP comments on barriers to market for molecular diagnostic tests at FDA CDRH meeting

Yesterday, the Association for Molecular Pathology (AMP) gave public comments at the FDA's Center for Devices and Radiological Health (CDRH) Council meeting on Medical Device Innovation: Barriers to Market for Molecular Diagnostic Tests.

28 Jun 2010

CardioGenics announces clinical test sites for QL Care portable blood analyzer

CardioGenics Holdings Inc., developer of the ultra-sensitive QL Care™ Point-Of-Care (POC) analyzer and products for the immunoassay segment of the In-Vitro Diagnostics market, announced the selection of four sites for clinical testing of its patented QL Care™ Analyzer, a portable diagnostic platform designed to produce test results with central lab-like accuracy in 15 minutes using whole blood.

21 Jun 2010

CardioGenics Holdings files Certificate of Change with the Secretary of State of Nevada

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 that the Company has filed a Certificate of Change with the Secretary of State of Nevada, which implements a share consolidation of the Company's authorized and outstanding common stock on a ten (old) for one (new) basis.

19 Jun 2010

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

In Vitro Diagnostics News and Research

Accuri Cytometers announces completion of $6 million Series E preferred stock financing

IRIS submits 510(k) application for clearance of iChemVELOCITY and iRICELL Urinalysis Workstation

Signature Dx obtains worldwide license to Affymetrix microarray technology for development of CRC tests

AMP comments on barriers to market for molecular diagnostic tests at FDA CDRH meeting

CardioGenics announces clinical test sites for QL Care portable blood analyzer

CardioGenics Holdings files Certificate of Change with the Secretary of State of Nevada

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

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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