The General Accounting Office (GAO) took three major federal departments to task today on their coronavirus responses and gave some pointed advice for the future. In a wide-ranging report, the GAO told the Department of Health and Human Services (HHS), the Federal Emergency Management Agency (FEMA) and the Department of Defense (DoD) how to better manage coronavirus-related […]
Feds unveil COVID-19 vaccine distribution plan
The Trump administration today released a plan to distribute an eventual COVID-19 vaccine free of charge, initially to targeted groups and more broadly as supply increases. The government is planning a phased distribution using a contract awarded to McKesson in August. The first recipients could include: Healthcare personnel likely to be exposed to or treat […]
Report: BD, Quidel struggle to supply antigen tests for COVID-19
Becton Dickinson (NYSE:BDX) and Quidel are struggling to fulfill orders for rapid COVID-19 antigen tests as the virus continues to spread, according to a report in the Wall Street Journal. The newspaper reported today that the two companies, which are the only ones that have FDA emergency use authorizations to sell the rapid diagnostics, cannot keep up with […]
Advamed: Diagnostic COVID-19 tests shipments hit 1m
U.S. shipments of COVID-19 molecular diagnostic tests reached 1 million per day for the week ending July 24, based on the latest data from AdvaMed’s national testing registry. The medtech trade group launched the registry July 21 to aid state and federal pandemic responses. “This incredible milestone is just the latest example of how the medical technology industry […]
HHS seeks 20m point-of-care COVID-19 antibody tests per month
The federal government wants U.S. diagnostics companies to develop rapid point-of-care COVID-19 antibody tests — using only materials made in the USA. The Department of Health and Human Services (HHS) on Thursday issued the call for submissions from companies that can quickly begin production of more than 20 million such tests per month. The tests must […]
PerkinElmer expects strong Q2 results from COVID-19 testing
PerkinElmer (NYSE:PKI) said today that it anticipates sales growth of approximately 12% for the second quarter, fueled by demand for COVID-19 tests and related products. The Waltham, Mass.-based diagnostic and scientific instrument company said demand for its RT-PCR and serology tests, RNA extraction systems and kits and automated liquid handling instrumentation was particularly robust. COVID-19 related […]
FDA warns of cyanide gas danger with improper use of Hologic COVID-19 tests
The FDA warned laboratories today that using certain transport media for COVID-19 samples with Hologic (NSDQ:HOLX) Panther and Panther Fusion diagnostic systems can produce deadly cyanide gas. Transport media is the liquid that maintains a specimen sample while it is transported to a laboratory. The Hologic Panther systems and others that have been sterilized using bleach […]
Abbott rapid COVID-19 test results questioned again
A new study by researchers at New York University has found that a COVID-19 rapid diagnostic made by Abbott (NYSE:ABT) missed up to 48% of positive results, renewing questions about its accuracy. This is the same test and lab equipment used at the White House, according to published reports. The study, conducted at NYU’s Langone Tisch […]
FDA grants Abbott EUAs for diagnostic, antibody testing platforms
The FDA so far this week has granted Abbott (NYSE:ABT) two emergency use authorizations (EUAs) allowing diagnostic and antibody tests to run on the company’s Alinity systems. The agency today authorized Abbott’s COVID-19 molecular diagnostic test for use on its new Alinity m molecular laboratory instrument. Abbott said it has begun launching the Alinity m system […]
Hologic to launch new COVID-19 diagnostic across U.S.
Hologic (NSDQ:HOLX) announced late this afternoon that it will launch a second high-throughput molecular diagnostic test for the coronavirus (SARS-CoV-2). Investors reacted by sending shares in HOLX up 8.27% in after-hours trading. The Marlborough, Mass.-based company said it aims to produce at least 1 million Aptima tests per week to run on more than 1000 of […]
Senate Dems propose federalizing medical supply chain
Senate Democrats today introduced a bill that would put control of the nation’s medical supply chain in the hands of the federal government, using its expertise in military production and distribution to address the COVID-19 pandemic. The Medical Supply Delivery and Transparency Act would require the secretary of defense to appoint a civilian with experience […]
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