Business Opportunities
by Gwyneth Astles
Expanded partnership targets high- sensitivity breast cancer testing
Biodesix, Inc has expanded its long-standing collaboration with Bio-Rad Laboratories to co-develop and clinically validate high-complexity Droplet Digital™ PCR (ddPCR™) assays for oncology applications. Under the new agreement, Biodesix will lead development, validation, and regulatory submissions for in vitro diagnostic assays based on Bio-Rad’s QX600 platform, including the ddPLEX ESR1 Mutation Detection Assay for advanced breast cancer.
ESR1 mutations are emerging as critical biomarkers in HR+/HER2- advanced breast cancer, guiding the use of next-generation oral selective oestrogen receptor degraders (SERDs). The ddPLEX ESR1 assay enables ultra-sensitive detection and quantification of multiple ESR1 mutations from circulating tumour DNA (ctDNA), supporting precision treatment decisions.
Following validation, Biodesix plans to offer the assay through its CLIA-CAP-accredited laboratory for both biopharma and clinical use, and will pursue CMS reimbursement to expand patient access. The
collaboration builds on the companies’ previous success applying ddPCR technology to Biodesix’s Lung Diagnostics portfolio, extending their joint expertise into breast cancer diagnostics.
“Expanding our partnership with Bio-Rad allows us to accelerate development of clinically relevant molecular assays that support targeted cancer therapies,” said Scott Hutton, CEO of Biodesix. “This collaboration demonstrates our shared commitment to delivering high- quality, data-driven solutions that improve patient care.”
Bio-Rad’s Steve Kulisch, VP Product Management, Life Science Group, added: “Our work with Biodesix highlights how Droplet Digital PCR can drive clinical innovation across oncology. Validating the ddPLEX ESR1 kit is a step toward broader access to sensitive biomarker testing in breast cancer.”
More information online:
ilmt.co/PL/JozB 66125pr@reply-direct.com
Che Connon.
UK-based cultivated meat innovator 3D Bio-Tissues has signed a Head of Terms with South Korea’s SeaWith, a leading developer of cultivated beef, to supply its premium cell culture media, City-Mix®, helping cut production costs by around 30%.
Collaboration aims to fast-track retinal therapy into clinical testing
SeaBeLife, a French biotech developing innovative therapies for degenerative retinal diseases, has signed a joint development agreement with Unither Pharmaceuticals, a leading international CDMO. The partnership will see Unither take the lead in formulation development, GMP manufacturing, and scale-up of SeaBeLife’s ophthalmic drug candidate, SBL03, ahead of planned clinical trials in 2027.
The collaboration allows SeaBeLife to use Unither’s industrial expertise and global footprint, while retaining ownership of the drug candidate. Together, the companies will manage preclinical and GMP batch production, analytical development, and regulatory preparation, sharing risks and costs associated with early-stage development.
“This agreement represents a strategic milestone for SeaBeLife,” said Morgane Rousselot, PhD, CEO. “By combining our scientifi c expertise with Unither’s manufacturing capabilities, we’re creating a clear path to clinical development and eventual commercialisation of our fi rst-in- class therapy.”
Unither’s Nathalie Masson, Director of Innovation and Development, added: “This partnership underlines our commitment to supporting innovative ophthalmology programs. By collaborating from formulation to scale-up, we help de-risk development and accelerate timelines for
The partnership aims to bring innovative retinal therapies to patients. Credit: Unither Pharmaceuticals
therapies addressing high unmet medical needs.”
The agreement also establishes a shared steering committee to monitor progress and approve key milestones, reinforcing a structured operational framework to bring SBL03 effi ciently through preclinical and clinical stages.
More information online:
lmt.co/PL/QKRb 66384pr@reply-direct.com
Under the agreement, 3D Bio-Tissues will provide a regular commercial supply of City-Mix® to SeaWith, supporting its efforts to scale up cultivated beef production. The deal, valued at approximately £300,000, marks a signifi cant step for 3D Bio-Tissues as it brings its technology into one of Asia’s fastest- growing cultivated-protein markets.
Founded in 2019, SeaWith uses seaweed-derived technologies to produce sustainable, slaughter- free meat alternatives. Its fl agship Welldone™ line focuses on cultivated beef designed for scalability and reduced environmental impact. The company has raised over $8 million in venture funding to date.
South Korea is emerging as a key hub for alternative proteins, supported by initiatives such as the Regulatory-Free Special Zone (RFSZ), which allows companies to bypass certain regulatory hurdles for fi ve years, accelerating commercialisation. With growing consumer interest and strong government support, the country’s cultivated meat sector is expected to expand rapidly in the coming years.
Che Connon, CEO of 3D Bio-Tissues, said: “Partnering with SeaWith brings City-Mix® to one of Asia’s most dynamic cultivated meat markets. Our technology not only boosts cell yield and tissue quality but also signifi cantly lowers production costs, helping make cultivated meat commercially viable at scale.”
Heejae Lee, CTO and Co-founder of SeaWith, added: “City-Mix® aligns perfectly with our high-performing muscle stem cells, supporting both robustness and scalability. This collaboration is an important step toward regulatory approval and commercial production.”
More information online:
ilmt.co/PL/6D75 66483pr@reply-direct.com
Partnership set to expand cultivated beef production in South Korea
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