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BioWorld - Tuesday, May 19, 2026
Home » Topics » Diagnostics, BioWorld

Diagnostics, BioWorld
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Stephen Hahn, FDA commissioner

FDA’s Hahn says need to deploy test for SARS-CoV-2 across platforms delayed development

March 11, 2020
By Mark McCarty
U.S. FDA commissioner Stephen Hahn appeared before a congressional panel to discuss the administration’s budget proposal for the agency, but the outbreak of COVID-19 predictably dominated the proceedings.
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Postponed stamp on calendar

Preparing for COVID-19, FDA shuts down inspections, postpones meetings

March 10, 2020
By Mari Serebrov
Despite the growing concerns about the potential for the community spread of COVID-19 in the U.S., the FDA-FTC public workshop on competition in the biologics marketplace went ahead as scheduled March 9, playing to a full house with some audience members sitting in an overflow room. And all the invited speakers and people registered to speak during the open public hearing session showed up.
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Coronavirus test tube, microscope, gloved hand

WHO releases COVID-19 roadmap; funding efforts in progress

March 9, 2020
By Nuala Moran
LONDON – The World Health Organization (WHO) has released its COVID-19 R&D roadmap, highlighting the gaps in knowledge about the virus and setting out priorities for research. The organization is now calling on groups around the world to use the document – drawn up by 400 experts – to coordinate their efforts.
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Europe under magnifier/petri dish with coronavirus

COVID-19: EU launches response team to coordinate efforts

March 2, 2020
By Nuala Moran
LONDON – The EU launched a “Corona” response team, bringing together oversight of all the separate strands put in place to control the virus, as the infection spread to 18 of 27 member states, with 2,100 confirmed cases and 31 deaths.
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Coronavirus viral membrane

Australia ramps up efforts to fight coronavirus with genetic sequence in hand

Feb. 12, 2020
By Tamra Sami
PERTH, Australia – As of Feb. 12, Australia’s Department of Health confirmed 15 cases of novel coronavirus in Australia (five in Queensland, four in New South Wales, four in Victoria and two in South Australia). Of the confirmed 15 cases, five people have recovered and the others are in stable condition.
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Coronavirus diagnostic test

Hong Kong researchers create fastest coronavirus diagnostic test to date

Feb. 7, 2020
By David Ho and Elise Mak
HONG KONG – A team of researchers at Hong Kong University of Science and Technology (HKUST) claim to have invented the world’s fastest portable 2019-nCoV diagnostic device. From sampling to testing, the device is apparently able to detect the novel coronavirus in just 40 minutes. In comparison, the polymerase chain reaction (PCR) technology that is currently in use can take between 1.5 to 3 hours. The device draws on the latest microfluidic chip technology from Shenzhen Shineway Hi-Tech Co. Ltd.
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2-3-Azar-HHS.png

HHS declares public health emergency in part because CDC test for coronavirus unreliable

Feb. 3, 2020
By Mark McCarty
The U.S. Department of Health and Human Services has declared a public health emergency in the U.S. over the coronavirus in part because a government diagnostic for the virus yields inconsistent results, a fact that may spur the life sciences to provide a solution.
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Hand holding dollar sign

IDbyDNA snags $20M in series B funding

Jan. 30, 2020
By Meg Bryant
IDbyDNA Inc., a San Francisco-based metagenomics technology company, scooped up $20 million in series B financing in a round led by Artis Ventures. Genesys Capital and others participated in the round. The company plans to use the money to accelerate uptake of its Explify software platform.
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DNA NGS genome sequencing

CMS loosens restrictions on next-gen sequencing in coverage memo update

Jan. 28, 2020
By Mark McCarty
The U.S. Centers for Medicare and Medicaid Services (CMS) has significantly relaxed the national restrictions on coverage of next-generation sequencing for cancer, affirming that early-stage breast and ovarian cancer patients will be covered. However, Medicare administrative contractors can cover tests that have not been reviewed by the FDA, a move that should also significantly boost utilization for makers of next-generation sequencing systems in clinical labs.
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Patent gears

Congress not expected to act on patent subject matter eligibility this year

Jan. 28, 2020
By Mark McCarty
The patent subject matter eligibility problem has rattled the world of diagnostics for several years, but the U.S. Senate has been silent about legislation in recent months. Patent attorney Michael Borella, of McDonnell Boehnen Hulbert & Berghoff LLP (MBHB), said he does not expect Congress to provide any legislative fix to the problem any time soon.
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