Lab Sciences
Top stories summarized by our editors
4/6/2020

Incyte said it is working with the FDA to launch a late-stage clinical trial to assess the use of its drug Jakafi, or ruxolitinib, as a treatment for patients with COVID-19, with Novartis, Incyte's partner, conducting the trial outside the US. The treatment will be tested to prevent a cytokine storm in COVID-19 patients.

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The Motley Fool
4/3/2020

The FDA has given emergency use authorization to Cellex's SARS-CoV-2 serology test, which can deliver results within 15 minutes.

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Regulatory Focus
4/3/2020

Siemens Healthineers has launched its Fast Track Diagnostics SARS-CoV-2 Assay and has sent kits to the EU for research use only. The company plans to obtain emergency use authorization for the test from the FDA and emergency use assessment and listing from the World Health Organization.

4/1/2020

The FDA has given clearance to Siemens Healthineers' RapidPoint 500e blood gas analyzer, used to monitor and diagnose patients who are critically ill. The device may be used to monitor respiratory distress in COVID-19 patients.

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MassDevice (Boston)
4/1/2020

A self-administered coronavirus test will be launched by UnitedHealth Group to help reduce the exposure risk of health care providers. A study found the swab tests accurately detected the virus in more than 90% of positive patients.

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UnitedHealth Group
4/1/2020

The FDA has given emergency use authorization to Bodysphere's COVID-19 test. The test can deliver results within 2 minutes and has a 99% sensitivity rate and 91% specificity rate.

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MassDevice (Boston)
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Bodysphere
3/31/2020

Bluebird bio said the trials of its LentiGlobin gene therapy for beta thalassemia as well as applications with the FDA will have to be deferred due to the COVID-19 pandemic. Commercial launch of the therapy is also being delayed in Europe, where it has been approved under the name Zynteglo.

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PMLive (UK)
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Thalassemia
3/31/2020

Laboratory managers should understand and be involved in their laboratories' finances to be seen as a profit center instead of a cost center, says Visiun President and CEO Thomas Joseph. Lab managers need to demonstrate value to hospital leaders as hospitals increasingly outsource or sell outreach programs, says Jane Hermansen, director of Mayo Clinic Laboratories' outreach consulting program.

3/30/2020

The FDA granted emergency use authorization to Abbott's ID NOW COVID-19 test, which can deliver positive results in five minutes and negative results in 13. The portable test is small enough that it can be used in most health care settings, and Abbott said it expects to manufacture about 5 million tests per month and deliver 50,000 tests per day starting this week.

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Business Insider, The Hill
3/27/2020

Researchers analyzed CT and X-ray images and reverse transcription polymerase chain reaction test results of 33 newborns from mothers with COVID-19 pneumonia and found that three of the babies were diagnosed with the infection. The findings, published in JAMA Pediatrics, highlighted the importance of screening pregnant women and implementing strict infection control strategies, close monitoring of newborns at risk for the illness and quarantining infected mothers, study authors wrote.