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Genoox

QIAGEN to Acquire Genoox for ~$80M

Shots: QIAGEN has entered into a definitive agreement to acquire Genoox, a provider of AI-driven software that allows clinical laboratories to scale & accelerate the analysis of complex genetic tests As per the deal, Genoox will receive $70M in cash & up to $10M in additional milestone payments Acquisition adds Franklin, Genoox’s cloud-based platform, to…

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PharmaShots Weekly Snapshots (May 05, 2025 – May 09, 2025) 

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, Biosimilar & Animal Health. Check out our full report below:    Recursion Presents Preliminary P-Ib/II (TUPELO) Trial Data of REC-4881 for Familial Adenomatous Polyposis (FAP) at DDW 2025  Read More: Recursion  Chengdu Origen and Vanotech Report the First Patient Dosing in P-I (VAN-2401)…

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ALPCO

ALPCO Launches its Calprotectin Immunoturbidimetric Assay for Irritable Bowel Disease Diagnosis in the EU

Shots: ALPCO has launched its Calprotectin Immunoturbidimetric Assay for the diagnosis of IBD, incl. Crohn's disease & ulcerative colitis in the EU ALPCO has also enrolled 1st pts in its pivotal trial for FDA clearance of its automated chemiluminescent calprotectin assay on the KleeYa system, following completion of the FDA pre-submission in Mar 2025, with…

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Roche

Roche Launches Elecsys PRO-C3 Test for Liver Fibrosis Severity Assessment

Shots: Roche has launched its Elecsys PRO-C3 test, developed with Nordic Bioscience to evaluate the severity of liver fibrosis in pts showing signs of metabolic dysfunction–associated steatotic liver disease  Elecsys PRO-C3 test requires a single assay & in combination with ADAPT formula (incl. PRO-C3 levels, platelet count, age, & diabetes status) provides clear assessment of…

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Endogenex

Endogenex Reports REGENT-1 Australian Clinical Study Data of ReCET System for Type 2 Diabetic Duodenopathy

Shots: Endogenex has reported REGENT-1 Australian study data of ReCET System for the treatment of inflamed & dysfunctional tissue associated with type 2 diabetic (T2D) duodenopathy; REGENT-1 is also being conducted in the US The study showed dose-responsive improvements in insulin sensitivity & beta cell function at 12wks., sustained through 48wks., with 100% procedural success…

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OcuSciences

OcuSciences’ OcuMet Beacon Receives the US FDA Clearance for Retinal Health Assessment

Shots: OcuSciences has received the US FDA clearance for OcuMet Beacon, a non-invasive confocal scanning ophthalmoscope designed for infrared & autofluorescence imaging of the human retina, with or without the use of a mydriatic agent Peer-reviewed clinical studies have showed favorable safety & clinical utility of the OcuMet Beacon, with dozen new studies presented at…

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Teleflex

Teleflex’s QuikClot Control+ Hemostatic Device Receives the US FDA’s 510(k) Clearance to Temporary Control All Bleeding Grades

Shots: The US FDA has granted 510(k) clearance for label expansion of QuikClot Control+ Hemostatic Device to control all grades of internal & external bleeding Label expansion was supported by real-world evidence from an observational study evaluating QuikClot Control+ in 603 US emergency, trauma, & surgical pts across all bleeding grades & varied anatomical sites…

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Personalis

Personalis Reports Interim VICTORI Study Data of NeXT Personal Assay for the Detection of Colorectal Cancer (CRC)

Shots: Personalis has reported interim VICTORI study data assessing its NeXT Personal assay for the detection of early residual or recurrent CRC via ctDNA using blood samples from 71 pts with resectable Stage I-IV CRC At 15.75mos. mFU, 100% pts with recurrences, incl. distant metastases, were detected via ctDNA before imaging, with 87% detected within…

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