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360Dx
@360dx.bsky.social
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Real-time news on the IVD market from the publishers of GenomeWeb. Read the latest news at 360Dx.com.
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360dx.bsky.social
www.360dx.com/cancer/kda-g...
KDA Group, AstraZeneca Canada Partner to Support Clinical NGS Testing for Breast Cancer
The collaboration aims to boost next-generation sequencing diagnostic testing for metastatic breast cancer patients at Hôpital du Saint-Sacrement in Quebec City.
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December 23, 2025 at 8:50 PM
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www.360dx.com/molecular-di...
Cystic Fibrosis False Negatives Spark Clinician Concern Around BillionToOne's Unity NIPT
The false negative rates do not appear out of line with the test's sensitivity figures, but issues have been raised with its workflow and the firm's marketing strategy.
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December 23, 2025 at 6:41 PM
360dx.bsky.social
www.360dx.com/regulatory-n...
Roche, Cytovale, Truvian Health, Others Secure 510(k) Clearances in November
The US Food and Drug Administration cleared a number of molecular tests and immunoassays, as well as a clinical chemistry and a cellular deformation test.
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December 23, 2025 at 6:40 PM
360dx.bsky.social
www.360dx.com/cancer/valar...
Valar Labs Partnering With PathNet for Bladder Cancer Testing
The deal gives clinicians in PathNet's national lab network access to Valar's AI-powered Vesta diagnostic portfolio for non-muscle invasive bladder cancer.
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December 23, 2025 at 6:39 PM
360dx.bsky.social
www.360dx.com/business-new...
Fulgent to Acquire Bako Diagnostics, StrataDx for $55.5M
Fulgent plans to implement its Eziopath digital pathology and AI image management system in the service labs.
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December 23, 2025 at 6:39 PM
360dx.bsky.social
www.360dx.com/cancer/chine...
Chinese MDx, Precision Medicine Firm GenePlus Files for IPO on Hong Kong Stock Exchange
The firm offers molecular diagnostics, CDx and drug development services, and AI-driven multiomics research services.
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December 23, 2025 at 6:38 PM
360dx.bsky.social
www.360dx.com/cancer/eu-un...
EU Unified Patent Court Rules in Favor of Myriad Genetics in Breast Cancer IP Dispute
The court invalidated a patent owned by South Korean firm GXD-Bio and rejected the firm's claims that Myriad's EndoPredict breast cancer test infringed on its intellectual property.
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December 23, 2025 at 6:38 PM
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www.360dx.com/business-new...
Trinity Biotech Inks New Financial Agreements With Perceptive Advisors; Sells 9M Rapid HIV Tests
The new financial agreements include $5 million of new term-loan proceeds to strengthen liquidity and funding for continued investment in product development.
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December 23, 2025 at 6:38 PM
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2025 Dx M&A Closes Strong With Trio of Massive Deals in Back Half of Year
2025 Dx M&A Closes Strong With Trio of Massive Deals in Back Half of Year
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December 23, 2025 at 6:34 PM
360dx.bsky.social
www.360dx.com/cancer/was-2...
Was 2025 a Turning Point for Digital Pathology? Maybe
The digital revolution is now more quickly transforming pathology lab workflows, pointing towards accelerating adoption in the coming years.
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December 23, 2025 at 1:52 PM
360dx.bsky.social
www.360dx.com/clinical-lab...
Paul Ehrlich Institut Designated EU Reference Lab for Blood Grouping Markers
In 2023 the institute was also deemed an EU reference lab for high-risk IVDs for the detection of hepatitis viruses, retroviruses, and respiratory viruses.
www.360dx.com
December 22, 2025 at 10:11 PM
360dx.bsky.social
www.360dx.com/cancer/guard...
Guardant Health Blood Test Receives Japanese Approval as CDx for Eli Lilly Breast Cancer Drug
The company's Guardant360 CDx received approval for identifying ESR1 mutations in breast cancer patients to assess their eligibility for treatment with Lilly's Inluriyo.
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December 22, 2025 at 4:02 PM
360dx.bsky.social
www.360dx.com/applied-bioc...
Applied BioCode Submits New Sample Prep Claim to FDA to Expand Use of Respiratory Panel
Applied BioCode said the FDA has already cleared its Gastrointestinal Pathogen Panel with the KingFisher Flex system for sample prep.
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December 22, 2025 at 4:01 PM
360dx.bsky.social
www.360dx.com/cancer/minim...
Minimal Residual Disease Testing Space Saw Key Trial Readouts, Commercial Consolidation in 2025
Over the year multiple clinical trial readouts validated the use of MRD for multiple indications, while companies in the space began to consolidate.
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December 22, 2025 at 4:01 PM
360dx.bsky.social
www.360dx.com/infectious-d...
Infectious Disease Diagnostics in 2025: Market Volatility Meets Rapid Technology Advancements
Approaches incorporating rapid or digital PCR, CRISPR, syndromic testing, and multimodal systems reached new milestones this year.
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December 22, 2025 at 3:09 PM
360dx.bsky.social
www.360dx.com/cancer/zydus...
Zydus Lifesciences to Market Myriad Genetics Cancer Tests in India
The deal covers Myriad tests used for hereditary cancer risk assessment, as well as for ovarian and prostate cancer treatment.
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December 22, 2025 at 2:55 PM
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www.360dx.com/business-new...
Top Five Articles on 360Dx Last Week: Rapid Adoption of BioMérieux SpotFire; Changes to IVDR; More
Last week, readers were most interested in a story about the reasons behind the rapid adoption of BioMérieux's SpotFire syndromic qPCR instrument.
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December 22, 2025 at 2:30 PM
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www.360dx.com/business-new...
CareDx Proposes Settlement Deal in Shareholder Class Action Lawsuit
The suit concerns the period from February 2021 to May 2022, when shares of CareDx fell more than 60 percent after the company disclosed it was being investigated by numerous government agencies.
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December 19, 2025 at 4:06 PM
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www.360dx.com/cancer/singl...
Singlera, Breakthrough Genomics Collaborating With U Pitt on Early Detection of Pancreatic Cancer
Under the collaboration, the parties will run a preclinical study evaluating Singlera and Breakthrough's BT-Reveal Early Pancreatic Cancer Test.
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December 19, 2025 at 4:06 PM
360dx.bsky.social
www.360dx.com/business-new...
In Brief This Week: Cofactor Genomics, Caris Life Sciences, Biocartis, Cancer Research Institute
News items for the week of Dec. 15, 2025.
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December 19, 2025 at 3:20 PM
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www.360dx.com/business-new...
Qiagen Details $500M Synthetic Share Repurchase Plan
Having previously announced the repurchase in November, the firm on Thursday gave shareholders additional information on the mechanism and timing.
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December 19, 2025 at 1:06 AM
360dx.bsky.social
www.360dx.com/clinical-lab...
2025 Clinical Lab Space Bookended by Demise of FDA's LDT Rule, Abbott's $23B Exact Sciences Deal
During the year, the industry saw continued consolidation, the end of a key advisory body, the rise in DTC testing and advanced diagnostics, and another stab at PAMA reform.
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December 18, 2025 at 4:24 PM
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www.360dx.com/cancer/perso...
Personalis MRD Assay Predicts Immunotherapy Response Across Solid Tumors in New Study
Circulating tumor DNA dynamics as determined by the NeXT Personal assay correlated with better treatment response and survival outcomes across 24 tumor types.
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December 17, 2025 at 9:48 PM
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www.360dx.com/business-new...
Hinting at Power Struggle, OraSure Technologies Investor to Nominate Members to Firm's Board
Altai Capital Management intends to nominate two candidates to its board of directors at an upcoming meeting of shareholders, OraSure said.
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December 17, 2025 at 9:48 PM
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www.360dx.com/point-care-t...
Skyrocketing Adoption of BioMérieux's SpotFire Spurred on by Speedy Syndromic Perks, Firm Says
Launched less than three years ago, the system may be changing how point-of-care tests are used in doctor's offices and emergency rooms.
www.360dx.com
December 17, 2025 at 3:44 PM