Entries by Bruce Carlson

COVID-19 Diagnostics Trends: 5 Minute Test; Confusion over 2 Minute Test; Non-COVID-19 Hospital Infections are a Worry

There has never been so much concerted global focus on IVDs.   And with good reason, as IVDs have always proved essential to detect infectious disease threats and steer treatment and resources.   This is true with the current crisis, even if it is the lack of COVID-19 diagnostics that was the focus of media attention.   How […]

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In Breaking Transmission Chain of COVID-19 and Other Diseases, Point-of-Care is Best Hope

Demand for testing has gone from a healthcare industry topic to a national crusade in weeks with the onset of COVID-19. High-throughput tests have been approved by the U.S. Food and Drug Administration (FDA) for use in the U.S. for the detection of SARS-CoV-2, the virus behind the disease. But for true intervention in doctors […]

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COVID-19: A Vaccine Solution?

Not since the Swine Flu epidemic of 2009 has there been this amount of emphasis on vaccines and vaccine development.  This new infectious disease threat with no anti-viral, nor vaccine is causing significant concern among healthcare providers, governments and the public.  Last-resort measures such as school closings and curfews in place in the United States […]

White House COVID-19 Plan Contains Diagnostics Boost

A rapid scale-up of diagnostic testing for the novel coronavirus was the focus of a declaration of emergency by President Donald Trump in a March 13 press conference. The plan calls for sharply boosting the production of coronavirus test kits while also making tests available at a network of drive-through sites. In an address at the […]

Slower-Than-Expected Adoption of Molecular Point-of-Care, But Growth Comes from Consumables

Molecular point-of-care diagnostic solutions offer improvements in the sensitivity and specificity of existing near-patient and rapid tests while expanding the diagnostic capabilities at points of care, such as hospital critical care units, physician offices, outpatient clinics, and community health posts in the developing world, and are used to assess conditions or admit patients.  The concept […]

Revival of VALID Act Draws Mixed Response

March 9, 2020 — The revival of legislation to change the regulation of laboratory-developed tests (LDTs) has drawn a mixed response. The reintroduction of the Verifying Accurate, Leading-edge IVCT Development (VALID) Act is intended to remove barriers that are believed to have impeded the U.S. government’s response to the coronavirus epidemic. The issue of diagnostics […]

Boost for Remote Patient Monitoring in COVID-19 Bill That Passed House, Senate

The House of Representatives and Senate today passed an $8.3 billion spending package to help providers and local governments handle the spread of the coronavirus and to boost the development of vaccines and tests of the virus.  While vaccine support and spending on healthcare is expected, the bill also  boosts telehealth solutions with financial support […]