In Vitro Diagnostics News and Research

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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

Sophia Genetics obtains CE-IVD marking for BRCA1/2 testing solution

Sophia Genetics, the European leader in Data Driven Medicine, has today obtained CE-IVD marking for its solution to detect BRCA1/2 associated genetic variants in live tumours.

14 Jan 2015

QIAGEN's circulating tumor DNA test CE-IVD marked to assess genomic mutation NSCLC patients

QIAGEN announced today the CE-IVD marking of its novel liquid biopsy-based companion diagnostic that analyzes circulating nucleic acids obtained from blood samples to assess an important genomic mutation in patients with non-small cell lung cancer (NSCLC), the most common form of this cancer.

From QIAGEN Manchester Limited 12 Jan 2015

DiaCarta raises $8 million in Series A financing from BVCF

DiaCarta, Inc., a privately-held biotechnology company raised $8 million in Series A financing from BVCF (BioVeda China Fund). Proceeds from Series A financing will be used to expand the product portfolio and support global commercialization. Dr. Weixin Xu of BVCF will join DiaCarta board of directors.

9 Jan 2015

Proteomics market expected to experience continual growth

The market for microarrays used to study the workings of proteins are in great demand, according to Kalorama Information. The healthcare market research publisher said "proteomics" instruments, reagents and testing are needed to discover new biomarkers and even new drugs, and that the market for them topped 5 billion dollars in 2013.

8 Jan 2015

FDA provides Emergency Use Authorization for Roche's LightMix Ebola Zaire rRT-PCR Test

Roche today announced that the U.S. Food and Drug Administration has provided an Emergency Use Authorization (EUA) for the LightMix Ebola Zaire rRT-PCR Test for use on patients with signs and symptoms of Ebola Zaire virus infection in conjunction with epidemiological risk factors, such as individuals traveling from West Africa.

From Roche Sequencing and Life Science 30 Dec 2014

Sophia Genetics earns ISO 13485 and ISO 27001 certification for safe data handling and security

Sophia Genetics, the European leader in Clinical Genomics and Next Generation DNA Sequencing (NGS), has become the first company to achieve both ISO 13485 and ISO 27001 certification for its commitment to safe data handling and security.

16 Dec 2014

FDA takes immediate steps to help reduce risk of spreading unsuspected uterine cancer

The U.S. Food and Drug Administration is taking immediate steps to help reduce the risk of spreading unsuspected cancer in women being treated for uterine fibroids, which is in keeping with Kalorama Information's view that in the female health market there is much room for improvement both in the development of products and the treatment of diseases.

29 Nov 2014

Synovasure PJI Alpha Defensin Test now available for sale in Europe

Zimmer today announced Synovasure PJI Alpha Defensin Test for Periprosthetic Joint Infection, the first and only test specifically designed for the diagnosis of Periprosthetic Joint Infection (PJI), is now eligible for sale in several European countries after earning key overseas certification this month.

19 Nov 2014