COVID-19 Diagnostics Trends: Immunoassay Gets EUA; OIG Report Blames Testing Delays; Traditional Diagnostic Testing Suffers

Due to the particularly dangerous nature of asymptomatic spread, epidemiological models predict that SARS-CoV-2 will inevitably spread in the U.S. This underlies the importance of diagnostic testing and having rapid methods to detect the virus, even in patients who show no symptoms. Despite the first case of coronavirus being reported on December 1, 2019,


Science and Medicine Group Support to Industry’s Fight Against Covid-19

Science and Medicine Group Inc. including Kalorama Information, SDi, BioInformatics, and IMV are marshaling our information and data resources to help those on the frontline in the fight against the COVID-19 virus. Science and Medicine Group Inc. is a market research and media company serving the life science, analytical instrument, diagnostic, medical imaging and dental […]


More POC COVD-19 Tests Approved: BioFire, Mesa

The FDA approved BioFire FilmArray COVD-19 test, as well as Mesa Biotech’s Accula.  Both can bring a COVID-19 diagnosis to the point of care where testing is most needed.   BioFire’s Film Array has thousands of placements.  Accula is a hand-held test.


POC Testing Joins “War” on COVID-19 with 45-Minute Cepheid Test

We projected in Kalorama’s  mPOC market study that molecular point of care ( mPOC ) would lead the fight in meeting the demand for COVID-19 testing with accurate and fast results.   Lab staff is at a premium, hospitals are taxed, and testing needs to happen where it can be useful to isolate patients.  We suggested that […]


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 […]


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 […]