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BioWorld - Sunday, July 5, 2026
Home » Topics » Medical technology » Diagnostics

Diagnostics
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Coronavirus and antibodies

FDA clears Memed’s point-of-care infectious disease test

Sep. 20, 2021
By Catherine Longworth
The U.S. FDA has cleared Memed Diagnostics Ltd.'s blood test for distinguishing between bacterial and viral infections. The diagnostic test has been tipped as an essential step in the fight against antimicrobial resistance. While most infectious disease tests look for the pathogen, Memed BV is an advanced host immune response test that measures the levels of immune system proteins and applies proprietary algorithms to generate an immune signature.
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Fingerprints in shape of lungs with magnifying glass and DNA

As targeted options expand, making the best match, and the most matches

Sep. 20, 2021
By Anette Breindl
Researchers have retrospectively divided more than 16,000 non-small-cell lung cancer (NSCLC) patients with EGFR mutations into four structure-based subgroups, and looked at how the members of each subgroup fared depending on which EGFR inhibitor they were given.
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Coronavirus data illustration

Researchers unveil algorithm to identify COVID-19 patients at high risk despite vaccination

Sep. 17, 2021
By Nuala Moran
LONDON – Researchers in the U.K. have applied the heft of national population-level databases to devise a new algorithm that predicts those people who are most at risk of hospitalization and death from COVID-19, despite having received two doses of vaccine.
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Fingerprints in shape of lungs with magnifying glass and DNA

As targeted options expand, making the best match, and the most matches

Sep. 17, 2021
By Anette Breindl
Researchers have retrospectively divided more than 16,000 non-small-cell lung cancer (NSCLC) patients with EGFR mutations into four structure-based subgroups, and looked at how the members of each subgroup fared depending on which EGFR inhibitor they were given.
Read More
Paul Hopper, founder and executive chairman, Radiopharm Theranostics
Newco news

Entrepreneur Paul Hopper launches Radiopharm Theranostics following AU$20M series A

Sep. 17, 2021
By Tamra Sami
PERTH, Australia – After raising AU$20 million (US$14.62 million) in a series A round, serial entrepreneur Paul Hopper is unveiling his newest venture, Radiopharm Theranostics Ltd., which is developing a platform of radiopharmaceutical and nuclear medicine products for both diagnostic and therapeutic uses.
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Lungs

Opgen’s multiplex diagnostic panel found to reduce inappropriate antibiotic use

Sep. 16, 2021
By Catherine Longworth
A multicenter study has found that a multiplex diagnostic panel developed by Opgen Inc. can reduce the use of inappropriate antibiotic therapy by 45.1%. Opgen’s Unyvero Hospitalized Pneumonia (HPN) panel uses PCR technology that can detect 21 pathogens and 17 antibiotic resistance markers in less than five hours. During the European Respiratory Society conference, Rockville, Md.-based Opgen presented data showing that combined with antibiotic stewardship, its HPN panel decreased time on inappropriate antibiotic therapy in hospitalized patients with pneumonia at risk for Gram-negative rods.
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ESMO 2021: Allarity shares edge up on post hoc analysis of dovitinib RCC data

Sep. 16, 2021
By Cormac Sheridan
DUBLIN – Allarity Therapeutics A/S plans to file an NDA with FDA for dovitinib in renal cell carcinoma (RCC) in the fourth quarter this year, after unveiling a new analysis at the European Society for Molecular Oncology’s virtual congress, which suggest that its companion diagnostic, DRP, can identify patients who obtain a survival benefit from the therapy.
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FDA Approved stamp with pills

FDA approves Takeda’s Exkivity for rare form of lung cancer

Sep. 16, 2021
By Richard Staines
Takeda Pharmaceutical Co. Ltd. has grabbed a slice of the non-small-cell lung cancer (NSCLC) market, becoming the first company to gain FDA approval for an oral drug targeted against a rare form of the disease.
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Hands holding gears

Finnish companies combine to form IVD triple threat

Sep. 15, 2021
By Catherine Longworth
Three is the magic number for Finnish companies Abacus Diagnostica Oy, Kaivogen Oy and Labrox Oy as they link up to develop a new diagnostic solution combining antibody and PCR testing on a single device. The three Turku, Finland-based companies said they are joining forces to form a new diagnostics powerhouse, harnessing their own unique expertise. Abacus Diagnostica develops molecular testing and rapid PCR tests while Kaivogen specializes in immunoassays and antibody tests and Labrox on laboratory instruments. All companies have previously collaborated on R&D projects.
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Gold wireframe handshake

Medial Earlysign partners with Roche Diagnostics for early cancer detection tools

Sep. 14, 2021
By Catherine Longworth
Startup company Medial Earlysign Ltd. and Roche Diagnostics International Ltd. are teaming up to bring to market artificial intelligence (AI) solutions for early detection of cancer. Founded in 2013, Tel Aviv-based Medial Earlysign uses machine learning tools to flag patients with a high probability of developing specific illnesses. The partnership with Roche will initially focus on gastric cancer.
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