Laboratory & Diagnostics

SHERIDAN, WYOMING - December 2, 2025 - Roche has secured FDA 510(k) clearance with a CLIA waiver and CE IVDR certification for its first point-of-care test to diagnose Bordetella infections, providing primary care and emergency clinicians with PCR-accurate results in just 15 minutes to help control whooping cough and related diseases.

Fast, PCR-accurate diagnosis at the point of care

Running on the cobas® liat system, Roche's new assay delivers lab-quality PCR results in GP offices and emergency rooms within a standard consultation. The 15-minute turnaround allows physicians to move from suspicion to definitive diagnosis immediately, supporting timely antibiotic prescribing that can prevent severe complications and reduce onward transmission.

SHERIDAN, WYOMING – July 8, 2025 – Bio-Rad Laboratories, Inc. has significantly expanded its presence in the digital PCR market with the launch of four new Droplet Digital™ PCR (ddPCR™) platforms, reinforcing its position as a global leader in life science research and clinical diagnostics. This strategic rollout includes the debut of the QX Continuum™ system and the QX700™ series, the latter resulting from Bio-Rad’s recent acquisition of digital PCR innovator Stilla Technologies.

Comprehensive ddPCR Portfolio Supports Precision and Scalability

By integrating the newly acquired technologies with its established QX200™ and QX600™ systems, Bio-Rad now offers the most comprehensive line of ddPCR instruments on the market. The portfolio includes over 400,000 assays designed to support a wide array of applications in life science and diagnostics.

The enhanced ddPCR offering delivers:

SHERIDAN, WYOMING – July 8, 2025 – Bio-Rad Laboratories, Inc. has announced a significant expansion of its recombinant monoclonal anti-idiotypic antibody and SpyCatcher reagent portfolios, reinforcing its support for bioanalytical assay development and antibody drug discovery across the life sciences sector.

Extended antibody coverage for leading biotherapeutics

The newly introduced anti-idiotypic antibodies target a range of high-profile biologics: pertuzumab (Perjeta), guselkumab (Tremfya), canakinumab (Ilaris), belimumab (Benlysta), and the bispecific antibody emicizumab (Hemlibra). These additions enhance Bio-Rad’s ability to support pharmacokinetic (PK) and anti-drug-antibody (ADA) assays that are essential for monitoring both innovator and biosimilar therapies.

SHERIDAN, WYOMING – June 1, 2025 – Roche has announced compelling final overall survival data from its phase III INAVO120 study, showing that the Itovebi™ (inavolisib)-based regimen reduces the risk of death by more than 30% in patients with PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer. The findings were presented at the 2025 ASCO Annual Meeting and simultaneously published in the New England Journal of Medicine.

First PI3K Inhibitor to Prolong Survival in This Breast Cancer Subtype

The INAVO120 trial demonstrated that Itovebi, when combined with palbociclib and fulvestrant, achieved a median overall survival (OS) of 34.0 months compared to 27.0 months for the control group receiving palbociclib and fulvestrant alone. This represents a statistically significant and clinically meaningful improvement (HR=0.67; p=0.0190).

SHERIDAN, WYOMING – June 1, 2025 – Roche has announced compelling new data from its ongoing FENopta open-label extension study, confirming that its investigational therapy fenebrutinib continues to provide sustained disease suppression in patients with relapsing multiple sclerosis (RMS) for up to two years.

The 96-week results presented at the CMSC Annual Meeting in Phoenix highlight fenebrutinib’s potential as a first-in-class reversible Bruton’s tyrosine kinase (BTK) inhibitor in the multiple sclerosis space. This development is poised to influence treatment paradigms, particularly as Phase III results approach later this year.

Sustained Disease Control With No Observed Disability Progression

SHERIDAN, WYOMING – May 27, 2025 – Roche has received a significant endorsement from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), which issued a positive opinion for Itovebi™ (inavolisib) in combination with palbociclib and fulvestrant. This recommendation positions Roche to offer a first-line treatment solution for adult patients with PIK3CA-mutated, ER-positive, HER2-negative, locally advanced or metastatic breast cancer—an area with limited current treatment options.

This development is underpinned by data from the phase III INAVO120 study, which demonstrated that the Itovebi-based regimen more than doubled progression-free survival compared to the standard treatment alone. The recommendation marks a key milestone toward potential European Commission approval, with broader implications for treatment standards across the region.

SHERIDAN, WYOMING – May 27, 2025 – Roche has announced FDA approval of its VENTANA® MET (SP44) RxDx Assay, marking a major milestone in companion diagnostics for non-small cell lung cancer (NSCLC). This approval paves the way for a more precise identification of patients eligible for AbbVie’s Emrelis™ (telisotuzumab vedotin-tllv), a targeted therapy for non-squamous NSCLC with MET protein overexpression.

Enhancing Treatment Precision in Lung Cancer Care

The VENTANA MET (SP44) RxDx Assay is the first FDA-approved companion diagnostic for detecting MET protein expression in NSQ-NSCLC patients. By identifying those with elevated levels of MET—a key predictive biomarker—the assay supports clinicians in selecting patients who are most likely to benefit from c-Met-targeted therapy.

SHERIDAN, WYOMING – May 27, 2025 – Roche has introduced its Elecsys® PRO-C3 diagnostic test, marking a major step forward in the assessment of liver fibrosis severity, particularly in patients with metabolic dysfunction–associated steatotic liver disease (MASLD). With the ability to deliver results in just 18 minutes, the new test is poised to streamline diagnostics and enable earlier, more accurate clinical decision-making.

Strategic Response to a Global Health Burden

MASLD, affecting approximately 30% of the global population, is increasingly prevalent due to rising rates of diabetes, obesity, and other cardiometabolic risk factors. While it contributes to around one in every 25 deaths globally, liver fibrosis associated with MASLD often progresses unnoticed until late stages, escalating risks of cirrhosis, liver failure, and cancer.

SHERIDAN, WYOMING – May 17, 2025 – Danaher Corporation has achieved a historic milestone in genomic medicine, enabling the development and delivery of the world’s first personalized mRNA-based CRISPR therapy for an infant with a life-threatening genetic disorder—in under six months. Powered by the Danaher Business System (DBS), this breakthrough exemplifies how disciplined innovation and cross-company collaboration can dramatically accelerate biopharmaceutical timelines and patient impact.

Compressing an 18-Month Timeline into Six

The urgency was real: an infant diagnosed with neonatal-onset CPS1 deficiency—a rare urea cycle disorder causing fatal ammonia accumulation—needed a cure in weeks, not years. DBS, Danaher’s proprietary system of operational tools and methodologies, allowed teams to strip away inefficiencies and take bold, calculated action.

SHERIDAN, WYOMING – May 8, 2025 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today introduced the Elecsys® PRO-C3 test, a groundbreaking diagnostic solution designed to assess liver fibrosis severity in patients with metabolic dysfunction–associated steatotic liver disease (MASLD). This innovative test, developed in partnership with Nordic Bioscience, provides healthcare providers with a fast and efficient way to evaluate liver fibrosis, a disease that contributes to one in every 25 deaths globally.

The Elecsys PRO-C3 test leverages Roche’s cobas® analyzers, delivering results in just 18 minutes, offering a swift and reliable diagnostic method. This new technology promises to significantly improve patient outcomes by enabling earlier identification of liver fibrosis, particularly in those affected by MASLD, and guiding timely treatment interventions.