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IVD Market

Scientist working in a laboratory on recombinant antibodies
|3 min read

Streamlining the Journey from RUO to IVD Assay with Recombinant Antibody Reagents

Consistent, well-characterized reagents and scalable manufacturing reduce development risk and support translation of innovative assays research to clinical application
byErika Leonard
Abbott and ALZpath are partnering to advance blood-based Alzheimer's testing, expanding access to pTau217 biomarker assays for clinical laboratories.
|2 min read

Abbott, ALZpath Expand Push Toward Routine Blood-Based Alzheimer's Testing

Clinical lab scientist holding a sample for PTEN protein assessment in prostate cancer.
|2 min read

FDA Clears Roche Test to Identify PTEN Loss in Prostate Cancer, Expanding Access to Targeted Therapy

Vanderbilt researchers have developed a minimally invasive RNA-based liquid biopsy that monitors T-cell activity in blood to predict in real-time how high-risk breast cancer patients will respond to immunotherapy.
|2 min read

Vanderbilt Researchers Leverage Liquid Biopsies to Predict Immunotherapy Response in High-Risk Breast Cancer Patients

New study utilizes RNA sequencing of peripheral blood to monitor T-cell activity, offering a potential alternative to invasive tissue biopsies for clinical laboratories and oncologists
byJanette Wider
Thermo Fisher Scientific will sell its microbiology unit to Astorg for about $1.1 billion as it refocuses on higher-growth areas.
Updated |2 min read

Thermo Fisher to Divest Microbiology Business to Astorg for $1.1 Billion

Private equity firm Astorg to acquire Thermo Fisher’s AST and culture media unit as the medtech giant sharpens its specialty diagnostics portfolio
byJanette Wider
If even 1 percent of adults in the US became kidney or partial liver living donors, the waitlists for kidney and liver transplants would significantly decrease.
|3 min read

Enhancing Transplant Success with Living Organ Donation and Advanced Diagnostics

As demand for organs grows, laboratory diagnostics remain central to donor evaluation and transplant success
byTina Liedtky
While this decision validates CLIA’s role, the history of this debate begs some practical considerations to inform both immediate decisions and long-term strategies.
|5 min read

Leveraging Regulatory Clarity in LDTs to Drive Laboratory Innovation

What steps should your lab take in response to shifting LDT oversight?
byJamie Platt, PhD
This marks a significant milestone for clinical laboratories in the United States.
Updated |2 min read

AliveDx's MosaiQ® Platform Registered with FDA as Class II 510(k) Exempt, Enabling US Labs to Adopt High-Throughput Automated Immunoassay Testing

MosaiQ is a next-gen immunoassay platform delivering automated, multiplexed testing and actionable insights for complex conditions
byAliveDx
Siemens Healthineers is the sole IVD manufacturer recognized by My Green Lab Accelerator for the EU and UK.
|3 min read

Greener Clinical Lab Testing Now Within Reach: New Solutions from Siemens Healthineers

The Atellica instruments from Siemens Healthineers are now My Green Lab ACT Ecolabel certified
bySiemens Healthineers
Photo of a medical laboratory professional wearing a white lab coat and standing in the clinical lab with their hands in their pockets.
|2 min read

District Court Overturns FDA’s LDT Rule: What the Ruling Means for Clinical Labs Now

Under the district court’s vacatur, the LDT final rule and its compliance deadlines are no longer in effect and cannot be enforced
byChristine P. Bump
Photo portrait of Peeter Padrik, MD, PhD, lead author and oncologist at Tartu University Hospital and health technology company Antegenes.
|3 min read

UK and European Experts Release Landmark Clinical Guidance for Breast Cancer Prevention

This new publication sets the standard, enabling more personalized and targeted breast cancer prevention and detection
byAntegenes
Photo of the front of the US Capitol Building, the seat of the United States Congress, with a USA flag flying in front and blue sky and clouds in the background. ADLM hosted a congressional briefing on laboratory-developed tests there on February 20, 2025.
|3 min read

Ensuring Quality Pediatric Care Through Laboratory-Developed Tests

ADLM congressional briefing explains the importance of laboratory developed tests for pediatric care and the FDA rule that will limit access to these critical tests
byAssociation for Diagnostics and Laboratory Medicine
With BD selling its diagnostics and life sciences business, clinical labs may see a new player could emerge in the IVD market.
Updated |2 min read

What BD Selling Its Diagnostics Business Could Mean for Clinical Labs

Becton Dickinson’s plans will shift the IVD market and possibly create a stronger contender
byScott Wallask, BA
A group of red flamingos standing in a pond—flamingos have been known to be infected and die from H5N1 bird flu infection.
|2 min read

Hologic to Contribute to H5N1 Bird Flu Test Development via Agreement Issued by CDC

To prepare for if the current H5N1 outbreak worsens, Hologic will work with the CDC to develop reagents that may be used for H5N1 testing
byHologic
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