As you may know if your laboratory does business in Europe, the European Union (EU) has been planning to implement an ambitious new device regulation called the In Vitro Diagnostic Regulation (IVDR). … [Read more...]
Global Diagnostics
EU Shuffles IVDR Implementation Plan but Sticks to May 2022 Start Date
August 26, 2021
Exact Sciences Scores Big as USPSTF Lowers Colorectal Cancer Screening Start Age to 45
June 14, 2021
Wouldn’t it be great if a government health task force recommended that people use the kind of test you create every year? Something like that just happened to Exact Sciences, maker of the Cologuard … [Read more...]
Genetic Testing
AMP Survey Finds that Inadequate Reimbursement Hinders Use of Molecular Diagnostics
May 5, 2021
Inadequate reimbursement is hindering utilization of molecular testing. That is the conclusion of a new survey from the Association of Molecular Pathology (AMP). Survey respondents also suggested that … [Read more...]
Industry Trends
Inside the Diagnostics Industry: Guardant Health Takes Aim at Exact Sciences’ Leadership of Colorectal Cancer Market
March 23, 2021
Colorectal cancer is a key segment of the U.S. and world diagnostics market that generates billions of dollars in test revenues per year and is projected to grow at an annual rate of nearly 6 percent. … [Read more...]
Precision Medicine
New ACOG Guidelines Recommend cfDNA-Based NIPT for All Pregnancies, Not Just Risky Ones
August 29, 2020
The American College of Obstetricians and Gynecologists (ACOG) has revised its position on noninvasive prenatal testing (NIPT) and is now recommending prenatal aneuploidy screening for all pregnant … [Read more...]
GENETIC TESTING
Inside the Diagnostics Industry: New Government BRCA Test Guidelines Are a Mixed Bag for Genetic Testing Labs
September 30, 2019
The US Preventive Services Task Force (USPSTF) issued updated recommendations for BRCA-related cancer risk assessment, genetic counseling and testing in the Aug. 20 issue of the Journal of the … [Read more...]
INSIDE THE INDUSTRY
Government Report Casts Doubt on Cost-Effectiveness of Leading Genetic Colorectal Cancer Screening Test
September 24, 2019
Few of the newfangled consumer genetic testing products have had greater commercial success and visibility than Exact Science's Cologuard colorectal cancer screening test. But a troubling new … [Read more...]
TESTING TRENDS
Search Intensifies for Markers for Prosthetic Joint Infection
June 26, 2019
Nearly one million total hip arthroplasties and total knee arthroplasties are performed in the United States each year, a number that is expected to continue to increase for decades given the aging of … [Read more...]
PUBLIC HEALTH
Partnerships, IT Solutions Improve Infectious Disease Diagnostic Stewardship
June 10, 2019
Appropriate use of testing is becoming a greater challenge, given the growing number of available diagnostic tests and their increasing complexity. While unnecessary or inappropriate testing can lead … [Read more...]
INSIDE THE DIAGNOSTICS INDUSTRY
The Practice of Early Gestational Diabetes Screening Evaluated
March 26, 2019
The U.S. Centers for Disease Control and Prevention estimates that each year, gestational diabetes mellitus (GDM) affects between 2 percent and 10 percent of pregnancies. Experts say there has been a … [Read more...]
