In Vitro Diagnostics News and Research

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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

mtm laboratories signs additional tranche of Euro 7 million to its Series C funding

mtm laboratories, a privately held diagnostics company developing, manufacturing and globally commercializing in vitro diagnostics for cervical cancer early detection and diagnosis, today announced the signing for an additional tranche of Euro 7 million to its Series C funding. This addition is a formal expansion of the Company’s last Series C in March 2008 and increases the total for the round to Euro 39 million (USD 57 million) in equity.

6 Oct 2009

Diamedix files a 510(k) premarket submission with the FDA for its Mago4S assay system

IVAX Diagnostics, Inc. announced today that its U.S. subsidiary headquartered in Florida, Diamedix Corporation, has filed a 510(k) premarket submission with the U.S. Food and Drug Administration (“FDA”) for its next -generation fully automated Enzyme-linked Immunosorbent Assay (“ELISA”) system for autoimmune and infectious disease testing, named the Mago®4S.

1 Oct 2009

Cepheid receives approval to market Xpert(R) HemosIL(R) FII & FV test

Cepheid and Instrumentation Laboratory (IL) today announced that Cepheid has received clearance from the U.S. Food & Drug Administration (FDA) to market its Xpert(R) HemosIL(R) FII & FV test.

25 Sep 2009

RAPS honors award recipients for contributions to healthcare product regulatory profession

The Regulatory Affairs Professionals Society (RAPS) today honored the recipients of its prestigious awards for outstanding contributions to the healthcare product regulatory profession. RAPS' Leonard Stauffer Award for mentoring and furthering regulatory professional education was given to independent consultant Nanci Dexter.

15 Sep 2009

FDA clears Diagnostic HYBRIDS' D3 FastPoint L-DFA Respiratory Virus Identification Kit

Diagnostic HYBRIDS, a leading developer of IVD fluorescent staining kits and cell culture products, today announced the U.S. Food and Drug Administration (FDA) (510k) clearance of its D3 FastPointTM L-DFATM Respiratory Virus Identification Kit, which allows the individual detection of influenza A, influenza B, respiratory syncytial virus (RSV), human metapneumovirus (hMPV), adenovirus and parainfluenza viruses from a patient’s specimen in under 30 minutes.

15 Sep 2009

New Influenza A/H1N1 detection kit launched

QIAGEN, today announced both the launch of a new Influenza A/H1N1 test and several updates to its activities in providing solutions for the global surveillance of the swine flu pandemic. QIAGEN’s new kit enables both the highly sensitive and specific detection of the novel Influenza A/H1N1, the virus that causes “swine flu”, as well as of all other known Influenza A and B virus strains.

10 Sep 2009

Cepheid's Flu Panel test to provide 45-minute identification of Flu A infection

Cepheid (Nasdaq: CPHD) today announced the accelerated development of a Flu A (Influenza Virus) Panel test for use on the GeneXpert((R)) System. The test will be designed to provide 45-minute identification of Flu A infection, with specific presumptive identification of seasonal H1, seasonal H3, and H1N1 novel strain types.

9 Sep 2009