MedTech Spectrum

Article Name Invitro & Invivo Diagnostic

QuidelOrtho Expands QUICKVUE Portfolio with FDA-Cleared Influenza + SARS Rapid Test

The new CLIA-waived immunoassay enables simultaneous detection of influenza A/B and SARS-CoV-2 in just 10 minutes, supporting faster, cost-effective decision-making at the point of care.

23rd September, 2025

Hesperos’ Human-on-a-Chip® and Digital Twin Platforms Redefine Disease Modeling

CEO Lawrence Florin discusses how human-relevant organ-on-a-chip systems and continuously updated digital twins are improving translational accuracy, reducing reliance on animal testing, and opening new frontiers in precision medicine.

13th August, 2025

TrilliumBiO and T-NeuroDx Partner to Advance Blood-Based Diagnostics for Early Alzheimer’s Detection

Strategic collaboration aims to accelerate validation and commercialisation of non-invasive tests, enabling earlier, more accessible diagnosis of Alzheimer’s disease

30th July, 2025

Aptitude Medical Secures $9M BARDA Partnership to Advance Rapid Filovirus Diagnostic for Ebola and Marburg Detection

New Metrix Filovirus Panel to deliver 30-minute, lab-quality results from blood samples in remote and point-of-care settings—marking a pivotal step in global outbreak preparedness.

29th July, 2025

The FDA Is Phasing Out Animal Testing

As regulatory shifts accelerate, next-generation non-animal models must rapidly evolve to ensure safety, efficacy, and innovation in human drug development.

23rd July, 2025

Fulgent Genetics Secures EU CE Mark for FulgentExome and FulgentPLM

Certification Advances Global Access to Comprehensive Genetic Testing and Precision Medicine Solutions in Europe

18th July, 2025

Overture Life Signs Agreement With Memorial Hospital Istanbul for World’s First Commercial Automated IVF Technology

Pioneering collaboration introduces next-generation automation to reproductive medicine, marking a breakthrough in accessible and standardized IVF care.

18th July, 2025

Oncomine Dx Express Test Gains FDA Approval, Expanding Thermo Fisher’s Precision Oncology Portfolio

The FDA approval of Thermo Fisher’s Oncomine Dx Express Test marks a key advancement in precision oncology, enabling fast, accurate detection of EGFR exon 20 insertion mutations and guiding NSCLC patients to targeted treatments like ZEGFROVY.

17th July, 2025

Artience Launches Functional Synthetic Polymers for Enhanced In Vitro Diagnostic Performance

Breakthrough polymer platform aims to improve sensitivity, stability, and efficiency across diagnostic assays and lab workflows.

10th July, 2025

Thermo Fisher’s NGS-Based Oncomine Dx Express Test Gains FDA Approval

FDA clears assay as companion diagnostic for ZEGFROVY™ and broad tumor profiling, advancing precision oncology diagnostics.

04th July, 2025

ProNephro AKI (NGAL) Test Enters U.S. Market for Diagnostic Use

Commercial Launch Marks a Key Step in Enhancing Early Detection of Acute Kidney Injury through Biomarker-Based Testing

30th June, 2025

Mursla Bio Unveils AI-Powered Precision Medicine Platform Leveraging Organ-Specific EVs

New technology isolates extracellular vesicles from blood to enable earlier, non-invasive disease detection and personalized treatment strategies.

18th June, 2025

Aptamer Group and Neuro-Bio Adapt Saliva-Based Alzheimer’s Test to ELISA Format, Advancing Towards Commercialisation

The partnership aims to deliver a non-invasive, hospital-compatible diagnostic using Aptamer’s Optimer binders and Neuro-Bio’s novel early-stage biomarker, with commercial rollout targeted within 12–18 months.

06th May, 2025

AMDI Launches Autolab™ HBH System to Transform Sample Preparation in Under 2 Minutes

Unveiled at ESCMID Global Congress 2025, the new Hyperbaric Heating-based platform eliminates the need for extraction kits—delivering faster, simpler, and cost-effective molecular workflows across diverse research and diagnostic applications.

14th April, 2025

Immunovia’s Next-Gen Blood Test Outperforms CA19-9 in Detecting Early-Stage Pancreatic Cancer

New results from the VERIFI study show Immunovia's test accurately detects 77% of early-stage cases and maintains strong specificity across diverse high-risk groups—strengthening commercial launch plans for Q3 2025.

25th March, 2025

VolitionRx Unveils Promising Data: Nu.Q® Immunoassay Detects 21 Cancers, Eyes Multi-Licensing Deals

With low false positives and broad detection capabilities, Volition’s Nu.Q® test could reshape the $20B liquid biopsy market, as the company advances licensing talks with major diagnostic players.

24th March, 2025

Gene Bio Medical and Bidiphar Form Strategic Joint Venture to Advance Global Healthcare

Collaboration aims to enhance pharmaceutical innovation and expand access to high-quality healthcare solutions worldwide.

17th March, 2025

Beckman Coulter Secures FDA Clearance for DxC 500i Clinical Analyzer

The integrated clinical chemistry and immunoassay system enhances efficiency, streamlines lab workflows, and delivers accurate diagnostics in a compact design.

11th March, 2025