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Instrumentation Laboratory announces European release of HemosIL Rivaroxaban Testing Solution

Instrumentation Laboratory today announced the commercialization of their HemosIL Rivaroxaban Testing Solution in Europe. The HemosIL Liquid Anti-Xa assay, when used in conjunction with HemosIL Rivaroxaban Calibrators and HemosIL Rivaroxaban controls offers an automated solution for measurement of rivaroxaban.

10 Aug 2015

Corgenix Medical to present several scientific abstracts at 2015 AACC Clinical Lab Expo

Corgenix Medical Corporation, the U.S. - based operation of ORGENTEC Diagnostika, is presenting several scientific abstracts at the 2015 American Association for Clinical Chemistry Clinical Lab Expo in Atlanta. Three abstracts involve the ReEBOV Ebola rapid diagnostic test (RDT) with a fourth abstract involving the AtherOx™ Assay for assessing heart disease risk.

25 Jul 2015

QIAGEN's therascreen EGFR RGQ PCR Kit to guide use of IRESSA for in NSCLC treatment

QIAGEN N.V. today received U.S. marketing (PMA) approval of its therascreen EGFR RGQ PCR Kit (therascreen EGFR test) as a companion diagnostic to guide the use of AstraZeneca's IRESSA (gefitinib) in the treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC).

From QIAGEN Manchester Limited 14 Jul 2015

Kalorama Information: NGS diagnostics can detect any number of genetic variants

Next generation sequencing may be able to bypass some of the downside of molecular testing and in doing so earn its place in clinical testing, according to Kalorama Information.

30 Jun 2015

SeraCare Life Sciences inks CRADA with NCI to create positive controls for cancer assays

SeraCare Life Sciences, a leading partner to global in vitro diagnostics manufacturers, today announced that it has signed a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute, part of the National Institutes of Health, to create reference materials and positive controls for cancer assays.

26 Jun 2015

IDT’s fully licensed MGB Eclipse qPCR probes available for online ordering

Integrated DNA Technologies (IDT), has become the only company to add fully licensed Minor Groove Binder (MGB) Eclipse GMP probes to its online service, enabling quick and efficient ordering.

From Integrated DNA Technologies 25 Jun 2015

Roche unveils series of new diagnostic technologies at EuroMedLab

Today at the 21st annual meeting of the IFCC-EFLM European Congress of Clinical Chemistry and Laboratory Medicines in Paris, France, Roche unveiled a series of new diagnostic technologies.

23 Jun 2015

Hitachi High-Technologies, QIAGEN form new strategic partnership to advance molecular testing

Hitachi High-Technologies Corporation and QIAGEN N.V. have entered into a long-term strategic collaboration involving initiatives to deliver important advances in molecular testing.

From QIAGEN Manchester Limited 18 Jun 2015

VENTANA ALK (D5F3) CDx Assay receives FDA approval

Ventana Medical Systems, Inc., a member of the Roche Group, today announced approval of the VENTANA ALK (D5F3) CDx Assay by the US Food and Drug Administration as a companion diagnostic to aid in the identification of patients for Pfizer's FDA approved targeted therapy, XALKORI (crizotinib).

15 Jun 2015

Bio-Techne to acquire 100% ownership of Cliniqa

Bio-Techne Corporation announced today that it has agreed to acquire 100% ownership of Cliniqa Corporation. Cliniqa specializes in the manufacturing and commercialization of quality controls and calibrators as well as bulk reagents used in the clinical diagnostic market.

From CLINIQA - Diagnostics Division 5 Jun 2015

Ventana, Halozyme partner to develop companion diagnostic assay for cancer treatment

Halozyme Therapeutics, Inc. and Ventana Medical Systems, Inc., a member of the Roche Group, announced today a global agreement to collaborate on the development of, and for Ventana to ultimately commercialize, a companion diagnostic assay for use with Halozyme's investigational new drug, PEGPH20

30 May 2015

First new treatment authorised in a decade for advanced cervical cancer patients in the UK

The European Commission has licensed Avastin in combination with standard chemotherapy for the treatment of women with advanced cervical cancer. Until now, the treatment has been available ahead of licence to eligible patients in England via individual requests to the Cancer Drugs Fund (CDF).

28 Apr 2015

Cepheid, FIND announce receipt of CE-IVD status for Xpert HIV-1 Qual test

Cepheid and FIND today announced that Xpert HIV-1 Qual, a qualitative 90-minute molecular HIV test, has achieved CE-IVD status under the European Directive on In Vitro Diagnostic Medical Devices.

16 Apr 2015

Mobidiag announces CE-IVD marking and launching of Amplidiag C. difficile+027 test

Mobidiag Ltd, a Finnish molecular diagnostics company specialized in the development of innovative diagnostics solutions for infectious diseases, today announced the launch of Amplidiag C. difficile+027, a qualitative qPCR-based test performed from DNA extracted from stool in suspected cases of C. difficile infection (CDI).

9 Apr 2015

Frost & Sullivan forecasts growth of global healthcare market

The healthcare industry is entangled in a transitory phase in which therapeutics, devices, products and services are sold into traditional care settings that are unable to keep up with the requirements placed upon it by changing demographics and consumer needs. At the same time, opportunities for new services and care, such as ambulatory, mobile, and home care, lack the appropriate level of maturity to provide robust revenue streams despite having the promise to increase healthcare delivery efficiency and reduce long term costs.

8 Apr 2015

Healthcare reform changes boost glucose testing in states with healthcare exchanges

A new study published in a major diabetes journal suggests that healthcare reform changes have boosted glucose testing in states that formed healthcare exchanges. The result confirms Kalorama Information's predictions on the topic.

From Quest Diagnostics 30 Mar 2015

MTI Expo 2015 to focus on engineering requirements in the medical technology sector

April 29-30, Ricoh Stadium, Coventry sees the next edition of the Med-Tech Innovation exhibition take place – engineering is the thread that runs through the whole show.

30 Mar 2015

Kalorama Information: Budding market for digital PCR reached 175 million in 2014

Kalorama Information estimated the budding market for digital PCR reached 175 million in 2014. The market research publisher said companies will be looking to provide products to increase research and diagnostics in diseases like cancer and neurological disorders.

13 Mar 2015

Tissue and cell diagnostics market reaches $7.7 billion in 2014

With fast and effective testing techniques, the tissue and cell diagnostics market was estimated to have reached $7.7 billion in 2014 for in vitro diagnostic (IVD) and other reagents used by clinical laboratories, according to Kalorama Information.

16 Feb 2015

Biocartis to develop Rapid Ebola Virus Triage Test

Biocartis believes its Rapid Ebola Virus Triage Test could provide a sustainable solution for rapid detection of Ebola-infected patients even after the current Ebola outbreak.

10 Feb 2015