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BioWorld - Saturday, December 27, 2025
Home » Topics » Medical devices and technologies » Diagnostics

Diagnostics
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Illustration of cancer in the pancreas
Diagnostics

Anti-CEA affibody for improved cancer detection and imaging

Oct. 30, 2025
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A team of scientists from KTH Royal Institute of Technology and Karolinska Institutet has reported the development and characterization of a new class of small non-immunoglobulin affibody proteins that bind to the highly glycosylated human carcinoembryonic antigen-related adhesion molecule 5 (CEACAM5, CEA) with high affinity.
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Green approved stamp

Roche receives CE mark for Elecsys Dengue Ag test

Oct. 29, 2025
By Shani Alexander
Roche Holdings AG received CE mark approval for its Elecsys Dengue Ag test, a fully automated, high-throughput immunoassay to help diagnose acute dengue virus infections. With cases of dengue on the rise worldwide, the test, which delivers results in 18 minutes, offers high sensitivity and specificity across all four dengue virus serotypes, and will help clinicians confidently distinguish dengue from other illnesses causing acute fever.
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Test tubes with blood samples

Blood test breakthrough could transform Alzheimer’s diagnosis

Oct. 29, 2025
By Tamra Sami
Australian scientists have developed a simpler, less invasive way to detect Alzheimer’s disease that could make it easier for patients to access emerging disease-modifying therapies. Researchers from Australia’s Commonwealth Scientific and Industrial Research Organisation have identified blood-based biomarker tests capable of confirming amyloid plaque in the brain with accuracy comparable to the current gold standards using positron emission tomography scans and lumbar punctures.
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Galleri instruction booklet on blood draw chair
ESMO 2025

Grail's DNA blood test improves early cancer detection sevenfold

Oct. 20, 2025
By Nuala Moran
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Grail LLC has presented data showing that when added to standard screening procedures for breast, cervical, colorectal and lung cancers, its Galleri circulating tumor DNA test led to a sevenfold increase in the number of cancers detected.


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Genedx’s Director of Laboratory Innovation Joe Devaney

Illumina's constellation tech a star in Genedx pilot

Oct. 15, 2025
By Annette Boyle
Genedx LLC partnered with Illumina Inc. to test whether Illumina's constellation map read technology could shed light on hard-to-detect variants that appear in rare diseases. Constellation met or exceeded the ability of other sequencing methods to detect variants implicated in multiple disorders and worked across a range of sample types, a study presented at the American Society for Human Genetics (ASHG) Annual Meeting in Boston on Oct. 15 found.
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IPO puzzle pieces

Ottobock raises €808M in public debut, Billiontoone files for IPO

Oct. 9, 2025
By Annette Boyle
Ottobock SE & Co. KGaA got the Frankfurt Stock Exchange on its feet and dancing with Germany’s largest IPO in more than 18 months Oct. 9. The €808 million (US$934.23 million) gave the prosthetics company a market capitalization of €4.2 billion (US$4.88 billion), which rapidly rose as the share price shot up from €66 to €72 at the start of trading. The second med-tech to go public in October should have more company soon, with U.S. molecular diagnostics company Billiontoone Inc. filing Oct. 7 for an IPO with placeholder value of $100 million.
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Diagnostics

Canadian researchers report radiolabeled diagnostic agents

Oct. 9, 2025
Simon Fraser University, TRIUMF and the University of British Columbia have disclosed radiolabeled compounds reported to be useful for the diagnosis of cancer.
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Illustration of kidney cancer showing tumor inside the kidney

Roche secures CE mark for kidney disease algorithm

Oct. 8, 2025
By Shani Alexander
Roche Holdings AG received CE-mark for the Kidney Klinrisk algorithm, an AI-based tool developed in collaboration with Klinrisk Inc. to stratify risk and assess the progressive decline in kidney function. The software will help clinicians to make more informed decisions when accessing adults with chronic kidney disease as well as individuals with diabetes or hypertension who are at elevated risk of kidney function decline.
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Owlstone’s Breath Biopsy Kit

Owlstone awarded $49.1M for multi-cancer detection test

Oct. 7, 2025
By Shani Alexander
Owlstone Medical Ltd. has been awarded up to $49.1 million in funding by the Advanced Research Projects Agency for Health (ARPA-H) to develop over-the-counter, at-home, cancer screening tests. These tests will be able to accurately detect more than 30 cancers as early as stage I, when tumors are still small and survival rates are highest, revolutionizing the field of cancer detection and improving patient outcomes.
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Cancer diagnostic illustration
Cancer

New AI model can assign certainty, or uncertainty, to predictions

Oct. 7, 2025
By Marian (YoonJee) Chu
No Comments
A team of U.S. and South Korean researchers have developed an AI model called MSI-SEER that can not only predict microsatellite instability-high (MSI-H) tumors based on tissue slides, but also flag “what it does not know.” “Have you ever asked ChatGPT anything, and the response was, ‘I don’t know?’” Cheong Jae-ho asked during an interview with BioWorld. “Probably not, and that is the problem with AI now.”
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