BioCentury | May 20, 2020
Product Development

Roche, Abbott say sample collection differences hampered COVID-19 sensitivity in independent studies

Roche and Abbott each responded to independent reports that their COVID-19 tests are less sensitive than claimed with additional validation data supporting stronger performance and statements attributing discrepancies to sampling protocols. Both companies pointed to...
BioCentury | May 14, 2020
Product Development

New scrutiny prompts withdrawal, re-evaluation of two rapid COVID-19 tests

A serological test withdrawal from BD and BioMedomics and reports of false negatives by Abbott’s point-of-care diagnostic highlight the need for regulatory oversight and independent validation in responses to the pandemic. FDA’s May 4 update...
BioCentury | May 12, 2020
Product Development

White House highlights new COVID-19 antigen test amidst focus on point-of-care technologies

The spotlight on the first FDA-authorized COVID-19 antigen test at Monday’s White House briefing suggests these rapid immunoassays are about to become a larger part of the conversation on COVID-19 testing. But the test’s technical...
BioCentury | Apr 18, 2020
Product Development

Roche latest heavy hitter to scale up serological tests

COVID-19 serological testing capacity is set to surge as diagnostic giant Roche joins the ranks of companies offering assays to detect antiviral antibodies. The ramp up in volume comes amidst ongoing uncertainty about the accuracy...
BioCentury | Apr 16, 2020
Product Development

Ortho becomes second to receive EUA for COVID-19 antibody assay

Ortho has become the second company after Cellex to receive Emergency Use Authorization from FDA for a COVID-19 antibody assay. Ortho Clinical Diagnostics Inc.’s test can be run on its VITROS systems. The company said...
BioCentury | Apr 15, 2020
Politics, Policy & Law

Medicare raises payments to increase high-throughput COVID-19 testing

CMS will almost double payments for COVID-19 diagnostic tests run on high-throughput equipment, the agency announced Wednesday. The increased payment of $100 per test, up from $51, is intended to increase use of high-throughput platforms....
BioCentury | Apr 15, 2020
Politics, Policy & Law

Pharma CEOs who quit White House council in 2017 join ‘Great American Economic Revival’ initiative

Nine pharma CEOs are among a list of over 200 executives, economists and scholars that have been named as members of White House “Great American Economic Revival” industry groups. The membership list released by the...
BioCentury | Apr 11, 2020
Product Development

COVID-19 roundup: Lilly joins NIH’s adaptive trial; plus Foresee, Congress, ASCO, BMS, Otsuka, EC, Terumo-Marker

Eli Lilly’s rheumatoid arthritis drug Olumiant baricitinib has become the second treatment added to NIH’s COVID-19 master protocol, joining Gilead’s remdesivir. Separately, U.S. representatives called on FDA to ensure diagnostics are accurate, and ASCO launched...
BioCentury | Apr 8, 2020
Product Development

Pushing limits of detection for the new coronavirus

Even as companies strive to create ever-more sensitive diagnostics for COVID-19, it’s still not clear what limits of detection are required to determine whether people are truly in the clear. The discovery that asymptomatic COVID-19...
BioCentury | Apr 7, 2020
Politics, Policy & Law

HHS providing $186M to bolster COVID-19 response as hospitals take extreme measures to stretch short supplies

HHS said Monday that CDC will provide $186 million to bolster local responses to the COVID-19 pandemic, the same day the agency's Office of Inspector General released the results of a hospital survey that found...
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