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Image: Positive case of lung tissue stained for ALK with VENTANA ALK (D5F3) CDx Assay, a companion diagnostic immunohistochemical test in the final stages of the FDA premarket approval process (Photo courtesy of Ventana Medical Systems and PRNewsFoto).

Premarket Approval Sought for CDx Test to Benefit Lung Cancer Patients

Ventana Medical Systems has announced its US FDA final-stage submission for premarket approval of its companion diagnostic immunohistochemistry test designed to identify ALK1-positive lung cancer patients that may benefit from treatment with targeted therapy that inhibits the ALK gene.   More...
26 Jan 2015

Report Predicts Double-Digit Growth for Protein Microarrays

Microarrays are in great demand for studying the workings of proteins, to discover new biomarkers and even new drugs, and for diagnostics. Among the tests useful in protein analysis, microarrays were among the fastest revenue growth category, according to Kalorama Information’s latest report “Proteomics Markets Research and IVD Applications.”  More...
20 Jan 2015
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CELLAVISION AB
KARL HECHT GMBH & CO KG

Aperiomics Presents Innovative Diagnostics Technology

Aperiomics, an early-stage company that is transforming infectious disease diagnostics, presented its new technology and investment needs at the 7th annual Biotech Showcase 2015 investors conference in San Francisco, in January 12–14, 2015.   More...
19 Jan 2015
Image:  Transasia Bio-Medicals’s Mr. Suresh Vazirani, CMD, and Ms. Mala Vazirani, Executive Director, receives the “Global Growth Company-2014” award from Mr. David Aikam, Managing Director, Head of New Champions, World Economic Forum (Photo courtesy of Transasia Bio-Medicals Ltd.).

WEF Selects Transasia Bio-Medicals for Global Growth Company Award

Leading in vitro diagnostics company Transasia Bio-Medicals has been selected as “Global Growth Company-2014” by the World Economic Forum, comprising top global enterprises.   More...
08 Jan 2015

Testing On Tissues and Cells Sector Reaches USD 7.5 Billion

Driven by new technologies and the need to discover biomarkers, the tissue and cell-based diagnostic market grew to an estimated USD 7.4 billion in revenues in 2013 for in vitro diagnostic and other reagents used by clinical laboratories, according to a new report from Kalorama Information.  More...
06 Jan 2015
Caption: The “Sofia Strep A+ FIA” test for rapid Group A Streptococcus detection has received the first simultaneous FDA clearance and CLIA waiver via the FDA’s new Dual Submission Program (Image courtesy of Quidel Corporation).

Bacterial Infection Assay Receives First Simultaneous FDA Clearance and CLIA Waiver

A Group A Streptococcus diagnostic test from Quidel Corporation has received the first-ever simultaneous FDA clearance and CLIA waiver via the new, time- and cost-saving Dual Submission Program of the United States Food and Drug Administration.  More...
05 Jan 2015

Strong Growth Forecasted for Women's Health Diagnostics

Key women's health diagnostics are showing strong growth worldwide, according to healthcare market researcher Kalorama Information, including, among others, the sectors for digital mammography, lab-based fertility testing, and bone densitometry.   More...
29 Dec 2014


LabMedica Industry News channel reports on mergers and takeovers, on cooperative agreements and on trends in the IVD industry worldwide.
 

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