FDA Reclassifies Rapid Flu Antigen Tests

Effective mid-February the U.S. Food and Drug Administration (FDA) is reclassifying antigen-based, rapid influenza virus antigen detection test systems (RIDTs) used directly on clinical specimens from … [Read more...]


Preemptive PGx Testing Gaining New Momentum

The application of pharmacogenomics (PGx) into routine, clinical care remains very limited, despite its potential to improve drug and dose selection based upon one's genes. Two new reviews, one … [Read more...]


Updated TB Guidelines Recommend Newer Tests

Patients at risk for tuberculosis (TB) infection should be assessed with newer tests, including interferon-gamma release assays (IGRAs) and molecular diagnostics, according to new guidelines developed … [Read more...]


Guidelines Suggest Standardized Interpretation and Reporting of Somatic Sequence Variants

A common refrain within the diagnostics industry is a need for standardization. Rapidly developing technology and testing methods, the call for interoperability, and the vast amount of data and … [Read more...]


2016 Year End Brought Closure to Many Diagnostic Deals

As 2016 came to a close, so too did a significant number of business deals involving diagnostic companies, tests and testing systems. Here's a summary of some of the recent transactions affecting … [Read more...]


FDA Watch: New FDA Approvals & Applications in Diagnostics

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...]


Inside The Diagnostics Industry: Medicare Coverage of Molecular Tests Continues to Evolve

Advanced diagnostic tests are emerging faster than the clinicians can document their clinical utility. All of this creates an interesting dilemma for payors as far as coverage is concerned. Normally … [Read more...]


Report Highlights Role Diagnostics Will Play in Food Allergy Safety

Despite the commonly held belief that the food allergy prevalence is rising, food allergies remain poorly studied and quantified, according a new report from the National Academies of Sciences, … [Read more...]


Sequencing Not Ready for First-Line, Newborn Screening

Scientists have been exploring the "hows" and "what ifs" of applying sequencing to newborn screening. However, two new National Institutes of Health-sponsored studies presented at … [Read more...]


Sequencing Following Ultrasound Improves Prenatal Diagnosis

Nonsevere fetal malformations and structural abnormalities are relatively frequent findings of routine, prenatal ultrasounds. Yet, these findings provide a diagnostic challenge for clinicians, as they … [Read more...]