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BioWorld - Monday, December 15, 2025
Home » Topics » Medical devices and technologies » Diagnostics

Diagnostics
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Christelle Ratignier-Carbonneil, CEO, ANSM

France’s ANSM increasing medical device surveillance

Nov. 9, 2021
By Bernard Banga
PARIS – The French National Agency for the Safety of Medicinal and Healthcare Products (ANSM), has published its latest annual report on the drugs and medical devices market in France. This body, placed under the supervision of the Ministry of Health, is responsible for monitoring all healthcare products throughout their cycle, for collating and analyzing reports of adverse reactions, and for implementing corrective action across the nation.
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Color Health Inc.’s genomics kit.

Color valuation reaches $4.6B with vibrant $100M series E

Nov. 9, 2021
By Annette Boyle
Color Health Inc. followed its rainbow to another pot of gold, collecting $100 million in a series E financing round led by Kindred Ventures and funds advised by T. Rowe Price Associates Inc. Returning funding round participants also included General Catalyst, the company’s long-time lead investor, Viking Global Investors and Emerson Collective. With the latest cash infusion, the company’s total funds raised to date reached $378 million and its valuation of $4.6 billion propelled it into the top dozen health care unicorns. Founded in 2017 as Color Genomics, the Burlingame, Calif.-based company has raised more than two-thirds of its total funding this year with today’s series E following the close of a $167 million series D round in January.
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South Korean won

Geninus endures rocky start in Korean Stock Exchange debut, but raises $34M

Nov. 8, 2021
By Gina Lee
Geninus Inc. endured a difficult debut on Korea Exchange’s Kosdaq board, but still raised ₩40 billion (US$33.83 million) through its listing. The 2 million shares on offer tumbled 25.56% at ₩13,400 (US$11.33) at the close of trading on Nov. 8, after Geninus priced them at ₩20,000.
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Quantumdx receives $20M equity investment to build on its pandemic-driven product line

Nov. 8, 2021
By Nuala Moran
LONDON – PCR point of care testing specialist Quantumdx Group Ltd. is poised to accelerate its commercial development in China, after the Hong Kong venture capital fund Vita Spring made a £15 million (US$20.3 million) equity investment.
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Green approved stamp

TGA greenlights Telix’s PSMA imaging agent Illuccix for prostate cancer

Nov. 5, 2021
By Tamra Sami
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has approved Telix Pharmaceuticals Ltd.’s lead prostate cancer imaging agent, Illuccix. Illuccix (TLX591-CDx) is a Gallium-based PSMA imaging agent and cold kit for developing radiopharmaceutical products and diagnostic agents. Telix’s prostate cancer program consists of a companion diagnostic imaging agent (TLX591-CDx) and a therapeutic (TLX-591) to improve the detection and treatment of prostate cancer.
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DNA illustration

Fapon Biotech takes over DNA sequencing firm Sequlite ahead of planned IPO

Nov. 4, 2021
By Doris Yu
Fapon Biotech Inc. expanded its presence in the global next-generation sequencing (NGS) market by acquiring all of the shares in U.S. firm Sequlite Genomics US Inc. With the acquisition, the Dongguan, China-based Fapon Biotech will manage Sequlite’s product development and business operation.
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Novel theranostic agent shows potential for immune-PET imaging and TRT in models of gliomas

Nov. 4, 2021
Image of smarphone showing Allara app

Allara sees huge demand for PCOS diagnostic with 10,000 women on waitlist

Nov. 3, 2021
By Annette Boyle
Allara Health Inc. officially launched its diagnostic test for polycystic ovary syndrome (PCOS) this week, but word of mouth has already established a waitlist of more than 10,000 women. The diagnostic tool evaluates a full panel of hormonal and metabolic markers, which are used with patient-reported symptoms, to diagnose the increasingly common condition.
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Business pipeline illustration

Trillium lab gets C$1M to close gap between high performing algorithms and patient outcomes

Nov. 3, 2021
By David Godkin
TORONTO – Trillium Health Partners has received a C$1 million (US$810,000) grant from TD Bank Group to help accelerate the use of artificial intelligence (AI) at a newly developed health care lab. The AI Deployment and Evaluation (AIDE) lab will determine if machine learning models developed by industry and academia work well outside the data sets upon which they were trained.
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Handshake with DNA, molecules

Astrazeneca and Saga Diagnostics link up for assay development agreement

Nov. 2, 2021
By Catherine Longworth
Astrazeneca plc has signed an agreement with liquid biopsy testing company Saga Diagnostics AB to develop dPCR assays. Lund, Sweden-based Saga Diagnostics will develop Sagasafe dPCR assays towards undisclosed methylated targets for analysis of tissue samples and liquid biopsies. The assay is part of Saga’s portfolio of “ultrasensitive technologies,” comprising Sagasign for personalized monitoring of cancer burden and minimal residual disease.
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