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 […]
Abbott COVID-19 test machine’s capacity questioned again
High-level questions about the performance of an Abbott (NYSE:ABT) device used to test samples for COVID-19 arose again yesterday. During Monday’s White House coronavirus briefing, Vice President Mike Pence said there is enough testing capacity within the country to begin phase one of President Donald Trump’s plan to reopen the economy — a notion that some […]
COVID-19 testing on Abbott lab machines running far short of need
U.S. laboratories are not running enough COVID-19 diagnostic tests using Abbott (NYSE:ABT) m2000 RealTime machines, according to Dr. Deborah Birx, White House coronavirus response coordinator. During last night’s White House briefing, Birx said that 80% of the Abbott machines in 120 laboratories across the country are not running, despite the availability of 1 million tests. Abbott […]
Hospital survey reveals front-line needs, desperate measures
Hospitals across the U.S. have begun resorting to unorthodox means of replacing or sanitizing personal protective equipment (PPE) and atypical sourcing of PPE and other supplies needed to fight the coronavirus pandemic, according to a government survey. The Department of Human Services’ Office of the Inspector General (OIG) conducted the random survey of 323 hospitals […]
FDA to authorize single-laboratory COVID-19 tests
The FDA said yesterday it will consider emergency use authorization (EUA) for molecular COVID-19 diagnostic tests to be used solely in the laboratories that developed them. The laboratories must be certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high-complexity tests. The tests must either be new or represent a significant deviation […]
Smiths Medical warns on LogiCal blood sampling system sets
Smiths Medical issued an urgent field safety notice to warn of corrective action for its LogiCal 5 ml closed blood sampling system sets and HemoDraw Plus closed blood sampling sets with the LogiCal pressure monitoring system. The company said in the notice out of Germany that it became aware that customers using the LogiCal and […]
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