Sofie Biosciences, Inc.

The medtech rumor mill is churning with speculation that GE HealthCare may be in M&A talks with Sofie Biosciences. Citing “people familiar with the matter,” the Financial Times reported that GE HealthCare could pay up to $1 billion for Sofie. Dulles, VA-based Sofie Biosciences develops and delivers molecular diagnostics and therapeutics (theranostics). During Wells Fargo’s annual healthcare conference last week, GE HealthCare CEO Peter Arduini said the company believes there are "some good opportunities with the right types of tuck-in M&A.” “Things that can actually build out the girth of the company, either defensive capabilities, but in many ways, moving us into new areas where you see more recurring revenue or higher mix,” Arduini said. He used the company’s Intelrad acquisition as an example. First announced in November 2025, GE HealthCare acquired Intelrad, a medical imaging software provider, for $2.3 billion. “Digital space, we can integrate more together around growing at high single digits, potential to grow faster, and margins in the 30s,” Arduini said. “And so those are the kind of things you're going to see more of.” Neither GE HealthCare nor Sofie Biosciences has commented on the deal speculation. The content above comes from the network. if any infringement, please contact us to modify.

GE HealthCare is said to be on the cusp of buying out radiopharmaceutical developer Sofie Biosciences, according to a report by the Financial Times. Citing “people familiar with the matter,” the FT said GE could pay out as much as $1 billion for the deal, which could come as soon as this coming week. Neither company has so far commented on the report. Sofie Biosciences, a 20-year-old Dulles, Virginia-based based medtech, works on creating specialized chemicals used in scanning machines that looks for cancers. This deal, should it go ahead, would help bolster GE’s pharma diagnostics business. It’s currently one of the major manufacturers of medical imaging equipment, including MRI, CT and PET scanners. Back in April, GE said it was cutting its profit outlook while also making structural changes to its business and executive teams. This included a “strategic evolution of its operations and executive leadership team,” which created a new business segment, Advanced Imaging Solutions, by merging its former imaging and ultrasound units under one umbrella, led by Phil Rackliffe. GE HealthCare’s two formerly largest segments were combined to “create a more focused and connected end-to-end imaging ecosystem,” the company said at the time. In July, GE then said it was performing “a comprehensive strategic review” of its Patient Care Solutions business amid ongoing “operational fulfillment issues and supply chain constraints.”

Novartis has initiated a first-in-human Phase I trial of [⁶⁸Ga]Ga-DFC413 (JFI447), a Gallium-68-labeled radioligand designed to image fibroblast activation protein (FAP)-expressing lesions across multiple solid tumor types. The study is strategically significant because it positions DFC413 as a potential companion diagnostic within Novartis’s expanding FAP-targeted radioligand therapy program, where the therapeutic counterpart [¹⁷⁷Lu]Lu-NNS309 is already in clinical development. The open-label, multicenter Phase I study (NCT07630961) enrolls approximately 66 adults with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), HR+/HER2- breast cancer, triple negative breast cancer (TNBC), colorectal cancer (CRC), or soft tissue sarcoma. The trial is structured in two sequential parts. Part 1 characterizes [⁶⁸Ga]Ga-DFC413 as a standalone imaging agent, with primary endpoints measuring radiotracer uptake in tumors and organs via standardized uptake value (SUV) and SUV ratio (SUVr) metrics across a four-hour PET imaging window. Part 2 introduces a direct head-to-head comparison against [⁶⁸Ga]Ga-NNS309 (FFG233), an established FAP-targeting PET agent already evaluated in Novartis’s theranostic program, with the primary endpoint assessing concordance between the two tracers in detecting FAP-positive lesions per disease group. The trial is currently recruiting at a Novartis investigative site in Tokyo, with primary completion anticipated in January 2028, according to the trial record. FAP is a serine protease selectively overexpressed on cancer-associated fibroblasts in the tumor stroma of most epithelial malignancies, with minimal expression in normal adult tissue. This differential expression makes FAP an attractive target for tumor imaging, particularly in cancers such as PDAC and TNBC where the stroma is dense and conventional imaging may underestimate disease burden. [⁶⁸Ga]Ga-DFC413 belongs to the FAPI (FAP inhibitor) class of small-molecule radiotracers, which bind FAP and, when labeled with the positron-emitting isotope Gallium-68, enable non-invasive PET visualization of FAP-expressing lesions. The structural details and precise pharmacophore of DFC413 have not been disclosed in any public source; its FAP-targeting mechanism is inferred from the trial record’s explicit reference to FAP-positive lesion detection as a study endpoint. The comparator agent, [⁶⁸Ga]Ga-NNS309, is part of a FAP-targeting library that Novartis licensed in March 2021 from iTheranostics, Inc., an affiliate of SOFIE Biosciences, which had itself licensed the compound class from the University of Heidelberg — the academic institution where the FAPI series originated. NNS309 is paired with a lutetium-177-labeled therapeutic counterpart, [¹⁷⁷Lu]Lu-NNS309, currently being evaluated in a separate Novartis Phase I study. The tumor types selected for this study are notable for their stromal density and historically high FAP expression: PDAC in particular is characterized by a pronounced desmoplastic stroma that has long been recognized as both a barrier to drug delivery and a potential imaging target. The inclusion of soft tissue sarcoma alongside the more common epithelial tumors reflects the known FAP expression in certain sarcoma subtypes and broadens the potential clinical utility of the imaging agent. The trial does not restrict enrollment by line of prior therapy, allowing patients across the treatment continuum, which maximizes the diversity of tumor biology captured in the imaging dataset. For Novartis, this trial fits within a coherent radioligand therapy strategy built around theranostic pairs — diagnostic agents that identify patients likely to respond to a matched therapeutic. The company’s approved radioligand therapy lutetium PSMA-617 (Pluvicto) for prostate cancer established this model commercially, and the FAP program represents an attempt to extend it into solid tumors where PSMA-targeted approaches are not applicable. Whether DFC413 ultimately advances as the companion diagnostic for the NNS309 therapeutic program, or serves a distinct role, will depend on the imaging concordance and biodistribution data generated in this study. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.