Qiagen Adds to Leading Molecular Cancer Menu with FDA-Cleared JAK2 Test Kit

Qiagen Adds to Leading Molecular Cancer Menu with FDA-Cleared JAK2 Test Kit

The U.S. Food and Drug Administration (FDA) recently approved Qiagen’s ipsogen JAK2 RGQ PCR Kit for detection of the V617F mutation on the JAK2 gene associated with the myeloproliferative disorder polycythemia vera. The cancer test kit assists patient evaluation for the particular form of leukemia and is routinely tested in myeloproliferative neoplasms (MPNs) negative for mutation in the BCR-ABL gene. Kit availability for JAK2 testing will make the test more widely available to health systems for the implementation of personalized medicine for leukemia patients.


Cancer Moonshot Launches in 2017

Cancer Moonshot Launches in 2017

Rare bipartisanship at the end of the Obama administration led to the passage of the 21st Century Cures Act championed by former Vice President Biden. The Act’s leading provision authorized $1.8 billion over 7 years for National Institutes of Health (NIH)-administered research into cancer. Also relevant to cancer therapeutics and diagnostics market development were the Act’s provisions for easing requirements and accelerating review of FDA submissions.


Chinese Market Comes to the Fore in Cancer Diagnostics

Chinese Market Comes to the Fore in Cancer Diagnostics

In 2016, China is a clear market development priority for the IVD industry in the areas of cancer screening tests, companion diagnostics, and sequencing-based cancer assays.


Uncertain Consequences for U.S. Health Care Post-Election

Uncertain Consequences for U.S. Health Care Post-Election

Incoming Republican congressional majorities and an administration of president-elect Trump have injected plenty of uncertainty into the U.S. healthcare system. Dismantling the Affordable Care Act (ACA) will be a legislative priority of the new regime, but could take years to accomplish. Which ACA provisions are kept and how coverage is preserved for newly insured individuals are currently open questions.


Moonshot Initiative Promotes Next Generation of Molecular Cancer Diagnostics

Moonshot Initiative Promotes Next Generation of Molecular Cancer Diagnostics

Cancer is the common thread through several fronts of U.S. regulatory development, whether approval of targeted therapeutics; coverage and reimbursement decisions for advanced diagnostic laboratory tests (ADLTs); or expansion of FDA regulatory oversight over laboratory developed tests (LDTs). The disease is also a healthcare and research and development (R&D) focus of the Obama administration. Just as instrumental as cancer’s high societal burden and aging-driven rise in incidence, the proliferation of its genetic analytes and druggable targets has caught the attention of regulators.


IBM Watson Health and Quest Diagnostics’ Bid to Advance Clinical Sequencing Informatics

IBM Watson Health and Quest Diagnostics’ Bid to Advance Clinical Sequencing Informatics

With next-generation sequencing (NGS), research scientists and clinicians are provided abundant raw data, but also too often deficient analytics software also known as informatics. Vendor-specific sequencing informatics software has limited access to third-party research discoveries in genomics. Sequencing analytics already in the clinical field may struggle to remain current with quickly evolving understanding of the genomic, epigenomic and transcriptomic underpinnings in cancer.


WHO Study Explores Environmental Factors Behind Diseases with Significant IVD Markets

WHO Study Explores Environmental Factors Behind Diseases with Significant IVD Markets

Amidst rising threats posed by climate change and inadequate utilites infrastructure even in the developed world , the World Health Organization (WHO) released the second edition of its decadal global assessment of diseases impacted by environmental risks. The comprehensive WHO study summates the fraction of deaths and morbidity attributable to environmental factors such as air, water and soil pollution; radiation; occupational risks; built environments; agricultural methods; and climate and eco...


The Liquid Biopsy: The Promise and Challenge behind CTCs and cfDNA

The Liquid Biopsy: The Promise and Challenge behind CTCs and cfDNA

Kalorama Information offers comprehensive analysis of the cancer diagnostics market, including cancer testing services, with The World Market for Cancer Diagnostics, 6 th Edition. Liquid biopsy technology is also reviewed in The World Market for Molecular Diagnostics, 6 th Edition. A free Kalorama Information white paper regarding the market for laboratory-developed oncology tests is available here.

The localization of disease can make diagnostic insights inaccessible by routine IVD testing fo...


Take Stock of the LDT Market Landscape with the New Kalorama Information White Paper

Take Stock of the LDT Market Landscape with the New Kalorama Information White Paper

Kalorama Information offers comprehensive analysis of the cancer diagnostics market, including cancer testing services, with The World Market for Cancer Diagnostics, 6 th Edition. The free white paper regarding laboratory-developed oncology tests is available here.

The test service model has become a leading strategy for laboratories and even some IVD companies looking to expand their footprint in the cancer diagnostics market. In the leading U.S. market, company-owned test services have long ...


Affymetrix Acquisition Deepens and Complements Thermo Fisher’s Existing Product Groups in Clinical Molecular Testing, Translational Research, Flow Cytometry and Applied Testing

Affymetrix Acquisition Deepens and Complements Thermo Fisher’s Existing Product Groups in Clinical Molecular Testing, Translational Research, Flow Cytometry and Applied Testing

Kalorama Information offers additional analysis of the markets discussed below with an upcoming title on clinical and research microarrays as well as published reports including The Market for Prenatal, Newborn and Carrier Genetic Testing , The World Market for Cancer Diagnostics, 6 th Ed. , Proteomics Research Markets , The World Market for Flow Cytometry in IVD Applications , and The World Market for Veterinary Diagnostics.

Thermo Fisher Scientific’s reach in the global life sciences market ...