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.


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.


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 ...


Theranos Aims Big Outside of LDTs’ Esoteric Pigeonhole

Theranos Aims Big Outside of LDTs’ Esoteric Pigeonhole

More information regarding the clinical lab testing or clinical lab services market can be found in Kalorama Information’s Clinical Lab Services Market (Growth Opportunities, Competitive Analysis and Competitor Profiles). Kalorama also offers specialty market coverage of retail clinics with Retail Clinics 2015: Growth of Stores, Consumer Opinion, Leading Competitors, Sales of Products to Clinics (Diagnostic Tests, Pharmaceuticals, Vaccines), Clinic Sales Forecasts and Trends.

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Recent FDA Guidance Benefits IVD Companies in Companion Diagnostics

Recent FDA Guidance Benefits IVD Companies in Companion Diagnostics

On July 31, the U.S. Food and Drug Administration (FDA) issued its finalized guidance on companion diagnostics and an oversight framework for lab-developed tests (LDTs), which have so far escaped the regulatory scrutiny visited on in vitro diagnostic (IVD) tests. The greatest impact of the FDA’s recent release will fall in companion diagnostics (also known as pharmacodiagnostics) or tests that inform clinicians of the efficacy or benefit of a pharmaceutical based on the genetics of an individual...