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BioWorld - Friday, December 19, 2025
Home » Topics » Medical devices and technologies » Diagnostics

Diagnostics
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Coronavirus-lungs-test-tube
Swabs among next rate-limiting factors on testing

Test makers say testing volume ramping up quickly despite concerns over reagents

March 19, 2020
By Mark McCarty
The U.S. capacity for SARS-CoV-2 testing is limited by several items, including the swabs used to collect patient specimens, but the supply of reagents has been front and center recently. Despite those concerns, several private test makers said they are quickly ramping up production, including Thermo Fisher Scientific Inc., of Waltham, Mass., which said it has enough supplies of all types on hand to provide 2 million reactions per week, a volume that should increase to 5 million per week in April.
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U.S. flag and money

White House: Much more money needed to battle COVID-19

March 18, 2020
By Mari Serebrov
As the world goes to war with COVID-19, the U.S. is ripping open the purse strings to fund mobilization against both the coronavirus and the economic devastation it’s causing.
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Coronavirus test tubes
COVID-19

Diagnostics take center stage in COVID-19 fight

March 17, 2020
By Liz Hollis
The past week has seen a lot of movement in terms of tests to detect SARS-CoV-2, the virus that causes COVID-19. “It is notable that the diagnostics community is coming together in a way we have not seen in our 20 years covering this industry,” wrote William Blair analyst Brian Weinstein in a March 14 note. “Regulators, lab professionals, and manufacturers are all in a frenetic fury to try and get testing up and running, and we generally see a sense of ‘in it together’ playing out.”
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South Korean shield, coronavirus

South Korea approves first four COVID-19 test kits under urgent-use license

March 17, 2020
By Gina Lee
HONG KONG – South Korea’s Ministry of Food and Drug Safety (MFDS) recently granted the first urgent-use licenses to four COVID-19 novel coronavirus diagnostic kits to battle the pandemic in the country, which is home to one of the largest outbreaks in the world outside of China.
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3-17-BeholdAI-red-dot.png

Behold.ai secures 510(k) for Red Dot image recognition algorithm

March 17, 2020
By Nuala Moran
LONDON – Behold.ai Ltd. has secured U.S. FDA 510(k) approval for use of its Red Dot image recognition algorithm in the automatic diagnosis of life-threatening pneumothorax (collapsed lung). The product completes the analysis immediately, sending an alert to the radiologist as soon as an X-ray is taken. “It does in 30 seconds what would normally take up to 30 minutes,” said Simon Rasalingham, CEO of London-based Behold.ai.
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Octapeptide binds to pANXA2 with calcium-dependent affinity in solid tumors: a new imaging probe

March 17, 2020
Coronavirus test tubes
COVID-19

Diagnostics take center stage in COVID-19 fight

March 16, 2020
By Liz Hollis
The past week has seen a lot of movement in terms of tests to detect SARS-CoV-2, the virus that causes COVID-19. “It is notable that the diagnostics community is coming together in a way we have not seen in our 20 years covering this industry,” wrote William Blair analyst Brian Weinstein in a March 14 note. “Regulators, lab professionals, and manufacturers are all in a frenetic fury to try and get testing up and running, and we generally see a sense of ‘in it together’ playing out.”
Read More
DNA, dollars illustration

Liquid biopsy startup Karius raises $165M to enable more accurate, faster diagnosis

March 12, 2020
By Stacy Lawrence
Liquid biopsy has long been seen as key to the future of cancer diagnostics, treatment and even potentially prevention. But now, startup Karius Inc. has staked out its claim as the first to bring cell-free DNA analysis, which is often used in oncology and prenatal liquid biopsy applications, into the clinic for infectious disease detection, identification and treatment guidance.
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BioWorld MedTech’s Diagnostics Extra for March 12, 2020

March 12, 2020
By Meg Bryant and Anette Breindl
Keeping you up to date on recent developments in diagnostics, including: Preventing birth defects; Full-waveform inversion for brain imaging; From junk to noncoding to coding; An efficient strategy for Legionella detection.
Read More

Results from first-in-human study of [11C]SMW-139 as an in vivo neuroinflammation tracer in MS

March 12, 2020
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