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BioWorld - Saturday, December 20, 2025
Home » Topics » Diagnostics, BioWorld MedTech

Diagnostics, BioWorld MedTech
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Idylla platform

FDA approves Biocartis Idylla Cdx MSI colorectal cancer test

Sep. 16, 2025
By Shani Alexander
Biocartis Group NV received premarket approval from the U.S. FDA for its Idylla Cdx MSI test, developed in partnership with Bristol Myers Squibb Co., to help in the diagnosis and treatment of colorectal cancer. The cartridge-based, fully automated, sample-to-result test enables faster identification of patients with the disease who may benefit from therapeutic treatment.
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Gold coins and sprouting plants

Goodpath accelerates AI development following $18M series A

Sep. 12, 2025
By Holland Johnson
Goodpath Inc., a virtual provider of whole-person care for chronic conditions, raised $18 million in series A financing, led by Massmutual Ventures with participation from Healthy Ventures and current investors.
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Cancerguard

Exact Sciences’ Cancerguard MCED test launches for $689

Sep. 10, 2025
By Annette Boyle
Exact Sciences Corp. rolled out its multi-cancer early detection test nationwide to expand screening and identify malignancies when treatment has the greatest chance of being curative. Cancerguard can detect signals for cancers accounting for more than 80% of all cancer diagnoses in the U.S. each year.
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Chanelle Case Borden pipetting DNA samples into a tube for polymerase chain reaction.

OIG calls for compulsory emergency plans for independent labs

Sep. 9, 2025
By Mark McCarty
The U.S. Office of Inspector General said in a recent report that independent testing labs should be required to develop emergency preparedness plans for public health emergencies, a move that would affect industry giants such as Laboratory Corporation of America and Quest Diagnostics Inc.
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Illustration showing steps to business success

IMU Biosciences' platform reshaping immune system understanding

Sep. 5, 2025
By Shani Alexander
IMU Biosciences Ltd. is working to transform society’s understanding of the immune system. The company’s platform maps the immune system at molecular, cellular and system levels, to unlock new insights into immune-related health and diseases, paving the way for clinical applications that could improve patient outcomes.
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Flower with dollar sign

Cyted raises $44M for Endosign swallowable capsule sponge

Sep. 2, 2025
By Shani Alexander
Cyted Health Ltd. raised $44 million in a series B financing round to expand the reach of Endosign, its capsule sponge technology, in the U.S. Endosign is a minimally invasive device used to collect cell samples from the esophagus for the early detection of esophageal diseases, offering the potential to transform early cancer detection and improve health outcomes.
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Storx Sensors
Patents

Storx sensors monitor fetal health during labor and delivery

Aug. 29, 2025
By Simon Kerton
Researchers from the University of California, Davis (UC-Davis) continue to assemble intellectual property in support of their development of methods and techniques which improve the accuracy of wearable sensor technologies.
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Illustration of kidney cancer showing tumor inside the kidney

FDA issues CRL for Telix’s kidney cancer imaging agent

Aug. 28, 2025
By Tamra Sami
No Comments
Telix Pharmaceuticals Ltd. received an FDA complete response letter (CRL) a day after the Aug. 27 PDUFA date for its BLA for radiopharmaceutical renal cancer imaging agent, Zircaix (TLX250-CDx, 89Zr-DFO-girentuximab).
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Vibrant DNA double helix

Billiontoone study shows Northstar assay better guides cancer treatment

Aug. 27, 2025
By Annette Boyle
Billiontoone Inc.’s Northstar Select comprehensive genomic profiling liquid biopsy assay identified more treatable variants than other tumor profiling platforms in a study published in The Journal of Liquid Biopsy. Notably, the test found clinically actionable alterations substantially below the limit of detection for other tests.
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Red arrow pointing downward on a stock market ticker

Bio-Techne takes a hit on Exodx sale to Mdxhealth

Aug. 6, 2025
By Annette Boyle
Bio-Techne Corp. plans to sell its Exosome Diagnostics Inc. business to Mdxhealth SA for $15 million plus royalty payments, a steep cut from the $250 million the company paid to acquire Exodx in 2018. Mdxhealth estimates the unit will generate $20 million in revenue in 2026.
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