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NEWS

Natera Seeks PMDA Approval for Signatera CDx in MIBC

Shots: Natera has submitted an application to Japan's PMDA seeking approval of Signatera as a companion diagnostic (CDx) for muscle-invasive bladder cancer (MIBC) The submission expands the company's presence in Japan, where Signatera became the country's first PMDA-approved molecular residual disease (MRD) test for colorectal cancer in Jun 2026 Application is supported by data from…
August 5, 2026

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NEWS

Natera Reports Publication of Signatera MRD Test Results for Resected Metastatic Colorectal Cancer in JAMA Oncology

Shots: Natera has reported the publication of data on Signatera, a personalized MRD test for resected colorectal liver metastases (CRLM), in JAMA Oncology, with findings also presented at the ESMO GI 2026 The analysis incl. 298 pts from the GALAXY trial, an observational arm of CIRCULATE-Japan, assessing outcomes by MRD status & adj. CT (ACT) use…
July 6, 2026

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NEWS

Natera Launches Zenith Genomics in the US to Diagnose Rare Diseases

Shots: Natera has reported the commercial launch of Zenith genomics, a next-generation whole genome sequencing (WGS) assay designed to enhance the detection of rare diseases in the US The platform combines whole genome sequencing with long-read sequencing confirmation to detect genomic features such as tandem repeat expansions, supporting diagnosis of rare & ultra-rare conditions, &…
March 13, 2026

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NEWS

Natera Seeks US FDA Approval for Signatera Cdx To Support MRD-Guided Treatment in Bladder Cancer

Shots: The US FDA has received a premarket approval (PMA) application of Signatera CDx for the detection of molecular residual disease (MRD) in pts with muscle-invasive bladder cancer (MIBC) who may benefit from treatment with Tecentriq (atezolizumab) Submission was supported by the P-III (IMvigor011) trial, which met its 1EP & showed that Signatera-guided therapy improved…
February 2, 2026

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NEWS

Natera Acquires Foresight Diagnostics for ~$450M to Strengthen Ultrasensitive MRD Testing in Solid Tumors & Lymphoma

Shots: Natera has acquired Foresight Diagnostics, adding its PhasED-Seq phased variant technology with LOD95 of 0.3ppm & detection below 0.1ppm, further enhancing Natera’s capabilities in solid tumor MRD and expanding its IP portfolio of >500 issued/pending patents As per the agreement, Natera completed the acquisition in an all-stock transaction incl. $275M upfront & up to…
December 8, 2025

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NEWS

Longeviti Launches ClearFit AI Platform for Bedside Brain Ultrasound Access

Shots: Longeviti Neuro has launched ClearFit AI, a Brain Ultrasound Interface, creating a persistent acoustic window to the brain to enable real-time bedside ultrasound imaging after neurosurgery ClearFit AI combines sonolucent cranial implants, ultrasound compatibility, clinical workflow support, & AI-enhanced imaging to enable bedside brain assessment within existing neuro care workflows, potentially reducing CT/MRI transport…
July 8, 2026

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TOP 20

Top 20 Diagnostics Companies of 2026

Shots:  The global diagnostics market is rapidly evolving through AI-powered imaging, molecular testing, precision medicine, and digital pathology solutions. In 2025, Siemens Healthineers led the industry with $20.54B in diagnostics revenue, followed by Roche at $17.52B and GE HealthCare at $17.49B, reflecting the growing adoption of advanced imaging, lab automation, and AI-driven diagnostics across global…
May 29, 2026

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NEWS

Genentech Reports FDA Approval of Tecentriq and Tecentriq Hybreza for Adjuvant Muscle-Invasive Bladder Cancer With ctDNA-Guided Treatment

Shots: FDA approved Genentech's Tecentriq & Tecentriq Hybreza (atezolizumab & hyaluronidase-tqjs) as an adj. therapy for adults with MIBC who have ctDNA MRD after cystectomy, as identified by Natera’s Signatera CDx MRD assay, which received simultaneous FDA approval Approval was based on the P-III (IMvigor011) trial evaluating Tecentriq vs PBO in adults with MIBC & ctDNA…
May 18, 2026

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NEWS

Quanterix Seeks US FDA Approval for Multi-Analyte Algorithmic Blood Test to Diagnose Alzheimer’s Disease

Shots: The US FDA has received 510(k) premarket notification for the multi-analyte algorithmic blood test to diagnose Alzheimer’s disease Submission was backed by data across three independent cohorts & 1,800+ pts, published in the Alzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitoring The blood test uses Quanterix’s Simoa tech to integrate five AD biomarkers (p-Tau217,…
February 4, 2026

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INSIGHTS+

PharmaShots Q4 2025 Highlights 

Shots:  As 2025 wrapped up, the final quarter made one thing clear: biopharma is doubling down on scale, science, and speed. From October to December, the industry saw a surge in high-value M&A and strategic collaborations, with companies racing to strengthen pipelines across neuroscience, oncology, metabolic diseases, and next-generation platforms  The quarter was led by…
January 12, 2026

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