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BioWorld - Thursday, April 16, 2026
Home » Topics » Diagnostics, Medical technology

Diagnostics, Medical technology
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Cancer cell, DNA illustration

Industry, Supercluster invest CA$17.8M to better diagnose cancer recurrence and relapse

April 29, 2022
By David Godkin
Canada’s federally-funded Digital Technology Supercluster is joining with industry to invest CA$17.8 million (US$13.9 million) in an artificial intelligence (AI)-powered technologies program to advance personalized treatment for patients with cancer.
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Fallopian tubes, ovaries and uterus

Inoviq expands collaboration with UQ to develop exosome-based ovarian cancer screening test

April 22, 2022
By Tamra Sami
Inoviq Ltd. and The University of Queensland (UQ) are expanding a collaboration to develop an exosome-based ovarian cancer screening test. Researchers from UQ identified and validated exosomal protein and micro-RNA (miRNA) biomarkers that when combined in its OCRF-7 algorithm showed more than 90% accuracy to detect stages I and II ovarian cancer in an independent 500-sample retrospective case-control study, Inoviq CEO Leearne Hinch told BioWorld.
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Genome illustration

China clarifies regulations on sharing human genetic resources

April 20, 2022
By Tamra Sami
China’s Ministry of Science and Technology issued a draft rule on regulations governing sharing of human genetic resources that provides clarity on parts of the regulation that were previously ambiguous, Katherine Wang, partner at Ropes & Gray in Shanghai, told BioWorld.
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FDA icons

FDA revokes 5 COVID test EUAs at request of sponsors

April 19, 2022
By Mark McCarty
The U.S. FDA’s device center reported April 18 that it has revoked the emergency use authorizations (EUAs) for five tests for the SARS-CoV-2 virus, a seemingly significant reduction in the inventory of tests for the COVID-19 pandemic. However, the sponsor of the test in each of these revocations requested that the EUA be revoked, an indication that the market for some types of these tests is saturated.
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Coronavirus, lungs, hand holding stethoscope

FDA grants EUA for breath test for COVID, but impact on overall test volume is limited

April 18, 2022
By Mark McCarty
The FDA has granted an emergency use authorization (EUA) to Inspect IR Systems LLC, of Frisco, Texas, for the company’s namesake test that evaluates the patient’s breath for the presence of volatile organic compounds (VOC) indicative of the SARS-CoV-2 virus. The test is expected to increase the volume of testing by only 64,000 per month at the current rate of production, however, making this a technological breakthrough of limited impact on the COVID-19 pandemic.
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Gloved hand puts samples in portable testing device

Hong Kong researchers develop portable COVID-19 testing device

April 18, 2022
By Zhang Mengying
An interdisciplinary research team from the Hong Kong Polytechnic University has developed a portable testing device that can detect the COVID-19 virus within 40 minutes.
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Flag of Australia, sky background

Australia’s TGA meets legislated time frames for device, IVD reviews

April 18, 2022
By Tamra Sami
In its first report on device application processing times since it completed most of its medical device reforms, Australia’s Therapeutic Goods Administration (TGA) met all the legislated time frames for processing medical device applications during the six-month period from July 31 to December 2021.
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Natus logo, teal background overlaying medical concept image

Natus Medical investors sense a sweet payout with Archimed’s acquisition offer of $1.2B

April 18, 2022
By Annette Boyle
Health care-focused private equity firm Archimed Group agreed to acquire Natus Medical Inc. for $33.50 per share, a nearly 29% premium over the April 14 closing share price for the provider of medical devices to diagnose and treat neurological and sensory disorders. The deal will take Natus (NASDAQ:NTUS) private after more than 20 years as a publicly traded company.
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Woman working at computer in laboratory

Clinisys purchases cloud-based laboratory system Apollolims

April 13, 2022
By Catherine Longworth
Diagnostic testing group Clinisys Inc. has acquired cloud-based laboratory operations software company Apollolims in an undisclosed deal. Headquartered in Chertsey, U.K., and Tucson, Ariz., Clinisys will expand its public health, toxicology, and molecular diagnostics offering through the acquisition. The deal builds on the company’s combination with Sunquest and Horizon announced in January.
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Illustration of cell dividing

Newstem files for haploid human embryonic stem cell-based diagnostic

April 12, 2022
By Catherine Longworth
Newstem Ltd. filed a presubmission to the U.S. FDA for a de novo request and an in vitro diagnostic device with the EMA for its Newstem software diagnostic device (NSDD). The bioinformatics-based platform is a personalized diagnostic to inform oncologists about the presence of mutations in tumors and predict a patients’ resistance to chemotherapy treatments. The technology utilizes specialized stem cells (haploid cells) that carry just one set of chromosomes.
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