Clinical OMICs - Volume 2, Issue 1 - (Page 3)

Molecular Diagnostics in Personalized Medicine As much as we desire new, more informative diagnostic tests, we must ensure they are worth doing-and paying for. A CROWDED FIELD FOR NONINVASIVE PRENATAL SCREENING TESTS . . . . . . . . . . . . . . . . . . . 6 Growing market expected to reach $3.6 billion by 2019. WATCHING AND WAITING FOR CODES AND FEES . . . . . . . . . . . . . . . . . . . . . . . . . .11 Clinical labs look to new year for CMS to address unresolved fee and coding issues. BIOMARKERS AND CANCER: CORRELATION IS NOT CAUSATION . . . . . . . . . . .14 Correlation is not useless, though. It can guide decisions, especially if a particular mutation is correlated with outcome. OPINIONS DIVIDED ON PROPOSED FDA LDT REGULATIONS . . .16 The debate on laboratory developed tests boils down to whether clinical labs should come under the agency's control. Regular Features INNOVATOR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21 Reimbursing NGS Testing: A new working group will evaluate the clinical utility of NGS-based testing to help inform coverage and payment decisions. CASE STUDY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24 Generating Robust NGS Data for Personalized Medicine: Sensitive, robust target capture assays are essential to achieve accuracy when sequencing specific genomic regions. NEWS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 NEW PRODUCTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20 Cover: Zffoto-Deposit Photos Above: Klanneke-Deposit Photos; Kasto-Fotolia www.clinicalomics.com MEETING ROUNDUP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28 January 2015 Clinical OMICs 3 https://www.youtube.com/channel/UCXBPPWZv--Ne4NfAUHcc8hg https://twitter.com/ClinicalOMICs http://www.clinicalomics.com

Table of Contents for the Digital Edition of Clinical OMICs - Volume 2, Issue 1

Contents

Clinical OMICs - Volume 2, Issue 1