Twitter   LinkedInFacebookRSS  
Top 10 Stories Of 2018: FDA In Vitro Guidances, Flu Detection, And More

January 2, 2019 | It’s been a big year for the diagnostics industry. Developments have led to a fantastic year of product announcements and thoughtful discussions. As we head into 2019, we at Diagnostics World would like to take a moment and reflect on the groundbreaking achievements from this past year. In that spirit, here are the top 10 stories of 2018, ranked in order of popularity.

--The Editors

1. Scott Gottlieb Announces 3 New FDA Guidances Focused On NGS, In Vitro Diagnostic Development

FDA Commissioner Scott Gottlieb announced via Twitter new policies for the Administration he says are designed to “keep pace with fast-moving [next-generation sequencing] technologies.” This announcement coincides with a speech Gottlieb gave at the 2018 Community Oncology Conference. Read more


2. The Future of Flu Detection

While the severity of any given flu season can vary widely, the burden is always substantial—lost time, lost productivity, and lost lives. And this year’s flu season has been particularly active. The viruses are elusive, evolving from one year to the next and even changing over the course of an individual season. When the H1N1 flu virus emerged back in 2009 after the seasonal vaccine had already been developed, the strain spread and caused a global outbreak. But diagnostics also played a role. Read more

3. Alexion’s Quest To Test The Algorithm Of Rare Disease Diagnosis

Alexion, in collaboration with EPAM, has developed a software competition platform to allow the objective comparison of contributed algorithms for automated rare disease diagnosis. Read more

4. FDA Authorizes Blood Test To Aid In TBI Evaluation

The US Food and Drug Administration has granted the De Novo request for the commercialization of Banyan BTI (Brain Trauma Indicator), an in vitro diagnostic blood test to aid in the evaluation of adult patients with suspected traumatic brain injury. Read more

5. Leroy Hood On How Systems-Driven 21st Century Medicine Could Transform Healthcare

During the 25th annual Molecular Medicine Tri-Conference in San Francisco, Leroy Hood of the Institute for Systems Biology and Providence St. Joseph Health discussed his latest efforts to transform medicine through pioneering a systems-driven approach. Read more

6. The Big Push For Early Alzheimer’s Diagnostics

Today’s diagnostic methods for Alzheimer's disease, which evaluate cognition using traditional pen and paper tests, are less than ideal. The results can be combined with physical health, medical history, and information from family members or caregivers. If a patient does not perform well on a cognitive test, there are other potential causes of memory loss that still need to be ruled out. Thankfully there's been a recent push to advance Alzheimer's disease diagnosis. Read more

7. For Sepsis, Triage Testing Would Improve Patient Outcomes

While great effort is going into developing sepsis diagnostics that do a better job of identifying the pathogen responsible, little attention has been paid to another area that stands to have a significant impact on sepsis care: triage. Triage diagnostics that would rapidly identify patients with sepsis would be an important new tool in the fight against this health threat — even more so if they could be performed at the point of care. Read more

8. Mixed Views On Acute Kidney Injury Biomarkers In Clinical Practice

For patients presenting in the emergency room with chest pain, troponins are exquisitely sensitive markers of myocardial injury. Physicians can therefore quickly intervene—with aspirin, beta blockers or a procedure in the cath lab—to limit damage to the heart and preserve cardiac function. But should patients need heart surgery or percutaneous coronary intervention, the heart isn’t the only organ at risk. Such procedures can put the kidneys at particular risk as well. Unfortunately, identifying and intervening in acute kidney injury isn’t quite as easy. Read more

9. Industry, Governments On Board With WHO Essential Diagnostics List

Last week the World Health Organization released its first list of essential diagnostic tests to improve diagnosis and treatment outcomes. The WHO’s Essential Diagnostics List is a catalogue of the tests needed to diagnose the world’s most common conditions as well as a number of global priority diseases. The diagnostics industry has welcomed the list, and national governments have already begun developing their local lists. Read more

10. Mayo App Helps Consumers Interpret Genetic Test Results

Mayo Clinic teams up with Helix to raise the “genomic literacy” of consumers. Read more