The U.S. Food and Drug Administration (FDA) is plagued with chronic understaffing, scrutiny over the length of time for approvals, and an expanding workload, while also facing potential budget cuts … [Read more...]
FDA
FDA Reports Progress in Advancing Regulatory Science for Diagnostics
May 16, 2017
The U.S. Food and Drug Administration (FDA) recently unveiled its FY 2015-2016: Regulatory Science Progress Report. The report, the second of its kind under the Food and Drug Administration Safety and … [Read more...]
PRECISION MEDICINE
Genomic Markers May ID Risk of Chemo Side Effects
April 24, 2017
While much attention is focused on using genomic markers to target the effectiveness of treatments, simultaneous research is exploring use of genomic markers to identify patients at higher risk of … [Read more...]
PRECISION MEDICINE
Genomics May Predict Cancer Treatment Side Effects
April 13, 2017
While much attention is focused on using genomic markers to target the effectiveness of treatments, simultaneous research is exploring use of genomic markers to identify patients at higher risk of … [Read more...]
STAFFING
Survey Finds Soft Skills Sought in Hiring New Pathologists
April 13, 2017
It is no secret that new graduates may not be fully equipped with the necessary skills for their first job. Even among new pathologists, on-the-job training is necessary to fulfill both the technical … [Read more...]
FUNDING
Trump Budget Proposes Steep NIH Cuts, Hike to FDA User Fees
April 13, 2017
The headlines are harsh. "Terrible," devastating," and "crippling," are words the biomedical industry is using to describe President Trump's proposed cuts to science and … [Read more...]
PRECISION MEDICINE
Discordant Commercial, Next-Gen Tumor Profiling Results May be Clinically Relevant
March 13, 2017
Next-generation sequencing is increasingly becoming commonplace to match cancer-associated alterations with targeted treatments. But, a new study raises concerns that marked differences in results … [Read more...]
INVESTMENT
Dx Investments Hold Steady in 2016, Number of Exits Declines
March 13, 2017
Investments in the diagnostics and tools (Dx/Tools) sector remained steady in 2016, according to Silicon Valley Bank's annual report, Trends in Healthcare Investments and Exits 2017. The report … [Read more...]
INVESTMENT
2016 Investments Steady, Exits Decline
February 21, 2017
Investments in the diagnostics and tools (Dx/Tools) sector remained steady in 2016, according to Silicon Valley Bank's annual report, Trends in Healthcare Investments and Exits 2017. The report … [Read more...]
FDA
FDA Watch: New FDA Approvals & Applications in Diagnostics
January 18, 2017
A notable FDA Section 510(k) approval was granted before the close of 2016 for Foundation Medicine's FoundationFocus CDxBRCA, a next-generation sequencing-based companion diagnostic test. The FDA … [Read more...]
