Global Diagnostics

EU Shuffles IVDR Implementation Plan but Sticks to May 2022 Start Date

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...]

Exact Sciences Scores Big as USPSTF Lowers Colorectal Cancer Screening Start Age to 45

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

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

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

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

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

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

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

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

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...]


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