A Closer Lab-Patient Connection
Patient access to data from the clinical lab is increasing. What does this mean for those generating it?
Diagnostic Testing and Emerging Technologies
Keeps You Up-to-Date on New Diagnostic Tests, Testing Trends and Opportunities, and Emerging Test Technologies
New and Improved: The Latest Research in Disease Screening
New ideas and innovations look beyond conventional screening options to facilitate improved disease diagnosis and patient outcomes
A Lasting Impact: COVID-19 and Cancer Screening
Several years after the onset of the COVID-19 pandemic, labs are still dealing with the effects of missed and delayed screenings
December 2022 FDA Watch: COPD, COVID-19, and MDD Tests Gain Clearance
A roundup of the significant new diagnostic tests and products that received regulatory approval in the US and around the world.
Want Breakthrough Device Designation? You’ll Need to Consider Health Equity
In draft guidance, the FDA is proposing that medical device makers will need to consider how accessible their products are to underserved populations.
New Urine Test Can Detect Synthetic Cannabinoids in Marijuana
Recent study shows the new test can identify a widespread and dangerous class of synthetic cannabinoids called BZO-CHMOXIZID.
New Study Supports Accuracy of Diagnoses from Video Visits
Video telehealth during the early period of the COVID-19 quarantine was actually highly effective in providing accurate diagnoses, research shows.
Polygenic Risk Scores Can Predict Chance of Sudden Cardiac Death
Recent study shows scores capable of assessing genetic risk of coronary artery disease can also ID those at high risk of death.
November 2022 FDA Watch: Pace of New Approvals Slows
Though there were fewer new approvals last month, the impact of the products that did gain approval more than made up for the drop in volume.
Abbott Ushers Monkeypox Testing into Its New Commercial Phase
Abbott has once more gotten the jump by becoming the first company to get EUA clearance for a commercial monkeypox RT-PCR test kit.
CMS to Create New Breakthrough Device Medicare Coverage Rule
The rule would ensure Medicare coverage of newly approved breakthrough devices, but have stricter evidence standards.
Blood Test Can Reliably Predict Patient Risk of Long COVID
Research offers new evidence that a test targeting blood-based biomarkers can predict someone’s risk of developing long COVID.
Pharmacogenetic Testing Leads to Better Depression Treatment Decisions
A recent study shows pharmacogenetic testing can help caregivers make better decisions when prescribing antidepressants.
