User Fees a Test of New Administration for Device Companies

User Fees a Test of New Administration for Device Companies

One test of the new admin’s stance towards the device industry will be the Medical Device User Fee agreement fee negotiations. It cost over $200,000 for a standard business to launch a new device with the FDA and $4,700 for a “shortcut” or 510 (k) application off a previously approved device. A further reduction or limited/no increase are goals of the industry.


CTCs, cfDNA and Tissue Biopsies: A Comparison

CTCs, cfDNA and Tissue Biopsies: A Comparison

Very small traces of DNA, and the development of tools to detect them, could revolutionize cancer diagnostics and resulting treatment. Circulating tumor DNA (ctDNA, a subset of cell-free DNA) and circulating tumor cells (CTCs) are shed by tumors into the blood and other body fluids. Two technologies in particular, next-generation sequencing (NGS) and digital PCR (dPCR), have allowed scientists to overcome the extremely low concentrations of these analytes. This article discusses the developments and compares the various approaches.


Five Things to Know About the Vaccine Industry in 2016

Five Things to Know About the Vaccine Industry in 2016

A lot happened in vaccines this year, but five trends stay out. The vaccine market continued its growth and innovation in 2016. Merck, Sanofi Pasteur, Pfizer, Glaxo Smith Kline and CSL are among the top companies in the market. Segment growth, the growing obesity challenge and delivery systems were among the trends noted this year. The healthcare market research publisher has studied vaccine markets for a decade, and this year published its report Vaccines 2016.


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.


Next-Generation Sequencing Trends

Next-Generation Sequencing Trends

2016 was a good year for next-generation sequencing. Robust investment, new product launches, regulatory clarity are among the trends that Kalorama notes development in this year. Also, NGS products in kit form is moving from theory to reality and China has emerged as a major player in NGS.