Last year saw the birth of the personal genomics industry, allowing consumers to gain access to their genetic information with varying levels of detail and explanation. Science singled out personal genomics services, now offered by such companies as deCODE Genetics, 23andMe, and Navigenics, as a 2007 "breakthrough of the year," while noting the range of bioethical issues raised by this type of testing. "The most profound implications of having one’s genome analyzed may not be what it reveals now—which isn’t much—but what it may show later on," wrote Joceyln Kaiser in Science.

But the advent of personal genomics may have more immediate ramifications for the in vitro diagnostics and laboratory industries. As it becomes more economically and technologically feasible for anyone to know every letter of their three million base pair genetic alphabet, broad-based genomic profiling performed by direct-to-consumer services such as 23andMe could herald a move away from testing for specific genetic mutations and toward a comprehensive, once-a-lifetime gene scan.

May 2008 - Table of Contents

DTTR May 2008 (full PDF issue)

Personal Genomics Raises Questions for IVD Industry

DCL Medical Laboratories Partners With Third Wave

FDA Clears Thermo Fisher’s MRSA Test

Fujirebio Diagnostics Buys American Biological Technologies

Study Finds Genetic Links to HIV Drug Response

Blood Count, Surgical Path Are Highest Volume Tests for CMS

As Companies Roll Out Personal Genomics Services, a Look at Five Key Players

Gen-Probe Begins U.S. Clinical Trial of HPV Test

PerkinElmer Appoints Lab Director for Genetic Screening Business

New Approach Reveals Gene Variations Linked to Type 2 Diabetes

Obesity Can Deter Women From Cancer Screening

CLIA Revises Quality Control Standards, Steps Up Inspections

IVD Stocks Gain 4%; Third Wave Climbs 34% on FDA Clearance

Learn From Outreach Testing Leaders