Akoya Biosciences Selects Argonaut Manufacturing Services as IVD Manufacturing Partner
Akoya Biosciences (NASDAQ: AKYA) has selected Argonaut Manufacturing Services as its manufacturing partner for in-vitro diagnostic (IVD) assays currently in development. This expanded collaboration builds upon their existing partnership, where Argonaut previously supported Akoya's Research Use Only (RUO) portfolio.
The partnership aims to manufacture high-quality IVD products under strict cGMP and ISO 13485:2016 requirements. Akoya's spatial phenotyping technology and PhenoImager platform have shown diagnostic capabilities for patient selection, while Argonaut's manufacturing systems will help scale IVD offerings to meet market demand.
This strategic collaboration reflects both companies' commitment to advancing precision medicine through high-quality diagnostics, with Argonaut's expertise in regulated markets and FDA requirements supporting Akoya's expansion in the companion diagnostic space.
Akoya Biosciences (NASDAQ: AKYA) ha scelto Argonaut Manufacturing Services come partner per la produzione di test diagnostici in vitro (IVD) attualmente in fase di sviluppo. Questa collaborazione ampliata si basa sulla loro partnership esistente, durante la quale Argonaut ha già supportato il portafoglio Research Use Only (RUO) di Akoya.
Il partenariato mira a produrre prodotti IVD di alta qualità sotto requisiti rigorosi di cGMP e ISO 13485:2016. La tecnologia di fenotipizzazione spaziale di Akoya e la piattaforma PhenoImager hanno mostrato capacità diagnostiche per la selezione dei pazienti, mentre i sistemi di produzione di Argonaut contribuiranno a scalare le offerte IVD per soddisfare la domanda di mercato.
Questa collaborazione strategica riflette l'impegno di entrambe le aziende ad avanzare nella medicina di precisione attraverso diagnosi di alta qualità, con l'esperienza di Argonaut nei mercati regolati e nei requisiti della FDA che supporta l'espansione di Akoya nello spazio della diagnostica complementare.
Akoya Biosciences (NASDAQ: AKYA) ha elegido a Argonaut Manufacturing Services como su socio de fabricación para ensayos diagnósticos in vitro (IVD) que actualmente se encuentran en desarrollo. Esta colaboración ampliada se basa en su asociación existente, donde Argonaut había apoyado anteriormente el portafolio de Investigación de Uso Exclusivo (RUO) de Akoya.
La asociación tiene como objetivo fabricar productos IVD de alta calidad bajo estrictos requisitos de cGMP e ISO 13485:2016. La tecnología de fenotipificación espacial de Akoya y la plataforma PhenoImager han mostrado capacidades diagnósticas para la selección de pacientes, mientras que los sistemas de fabricación de Argonaut ayudarán a escalar las ofertas de IVD para satisfacer la demanda del mercado.
Esta colaboración estratégica refleja el compromiso de ambas empresas para avanzar en la medicina de precisión a través de diagnósticos de alta calidad, con la experiencia de Argonaut en mercados regulados y requisitos de la FDA apoyando la expansión de Akoya en el espacio de diagnóstico complementario.
Akoya Biosciences (NASDAQ: AKYA)는 현재 개발 중인 인 비트로 진단(IVD) 검사를 위한 제조 파트너로 Argonaut Manufacturing Services를 선정했습니다. 이번 협력 확대는 Argonaut이 이전에 Akoya의 연구용(RUO) 포트폴리오를 지원한 기존 파트너십에 기반하고 있습니다.
이번 파트너십은 엄격한 cGMP 및 ISO 13485:2016 요구 사항에 따라 고품질 IVD 제품을 제조하는 것을 목표로 합니다. Akoya의 공간적 표현형 기술과 PhenoImager 플랫폼은 환자 선별을 위한 진단 능력을 보여주었으며, Argonaut의 제조 시스템은 시장 수요를 충족시키기 위해 IVD 제품의 규모를 확대하는 데 도움을 줄 것입니다.
이 전략적 협력은 두 회사가 고품질 진단을 통해 정밀 의학을 발전시키기 위해 노력하고 있음을 반영하며, Argonaut의 규제 시장 및 FDA 요구 사항에 대한 전문성이 Akoya의 동반 진단 분야 확장을 지원하고 있습니다.
Akoya Biosciences (NASDAQ: AKYA) a sélectionné Argonaut Manufacturing Services comme partenaire de fabrication pour les tests de diagnostic in vitro (IVD) actuellement en développement. Cette collaboration élargie repose sur leur partenariat existant, au cours duquel Argonaut a déjà soutenu le portefeuille de recherche à usage exclusif (RUO) d'Akoya.
Ce partenariat vise à fabriquer des produits IVD de haute qualité conformément à des exigences strictes en matière de cGMP et à la norme ISO 13485:2016. La technologie de phénotypage spatial d'Akoya et la plateforme PhenoImager ont montré des capacités diagnostiques pour la sélection des patients, tandis que les systèmes de fabrication d'Argonaut aideront à adapter l'offre d'IVD à la demande du marché.
Cette collaboration stratégique reflète l'engagement des deux entreprises à faire progresser la médecine de précision grâce à des diagnostics de haute qualité, l'expertise d'Argonaut dans les marchés réglementés et les exigences de la FDA soutenant l'expansion d'Akoya dans le domaine des diagnostics complémentaires.
Akoya Biosciences (NASDAQ: AKYA) hat Argonaut Manufacturing Services als seinen Fertigungspartner für die derzeit in Entwicklung befindlichen In-vitro-Diagnosetests (IVD) ausgewählt. Diese erweiterte Zusammenarbeit baut auf ihrer bestehenden Partnerschaft auf, bei der Argonaut Akoya zuvor bei seinem Research Use Only (RUO) Portfolio unterstützt hat.
Das Ziel der Partnerschaft ist die Herstellung von hochwertigen IVD-Produkten unter strengen cGMP- und ISO 13485:2016-Anforderungen. Die räumliche Phänotypisierungstechnologie von Akoya und die PhenoImager-Plattform haben diagnostische Fähigkeiten zur Patientenauswahl gezeigt, während die Fertigungssysteme von Argonaut helfen werden, das IVD-Angebot an die Marktnachfrage anzupassen.
Diese strategische Zusammenarbeit spiegelt das Engagement beider Unternehmen wider, die Präzisionsmedizin durch hochwertige Diagnostik voranzutreiben, wobei die Fachkenntnisse von Argonaut in regulierten Märkten und FDA-Anforderungen die Expansion von Akoya im Bereich der begleitenden Diagnostik unterstützen.
- Strategic expansion into IVD manufacturing indicates growth in diagnostic market
- Partnership provides access to cGMP and ISO 13485:2016 certified manufacturing
- Demonstrated diagnostic capabilities of PhenoImager platform for patient selection
- IVD assays still in development phase, indicating no immediate revenue impact
Insights
This manufacturing partnership marks a pivotal strategic advancement for Akoya Biosciences' commercialization efforts in the $85 billion global in-vitro diagnostics (IVD) market. The selection of Argonaut as a manufacturing partner carries several critical implications for investors:
First, this partnership significantly de-risks Akoya's IVD development pathway. Argonaut's established track record in cGMP manufacturing and ISO 13485:2016 certification provides a reliable infrastructure for scaling regulated diagnostic products. This is particularly important as Akoya transitions from research-use-only (RUO) products to FDA-regulated companion diagnostics, which typically command higher margins and more stable recurring revenue streams.
The strategic value becomes apparent when considering that successful IVD commercialization requires:
- Robust quality management systems that meet stringent regulatory requirements
- Scalable manufacturing capabilities to meet market demand
- Consistent product quality across manufacturing batches
- Cost-effective production to maintain competitive pricing
Argonaut's existing familiarity with Akoya's technology through their RUO portfolio collaboration significantly reduces operational risks and potential manufacturing transfer complications. This established relationship should accelerate time-to-market for Akoya's IVD products while minimizing development costs.
In the broader context of spatial biology applications in precision medicine, this partnership positions Akoya to capitalize on the growing demand for companion diagnostics, particularly in oncology. The PhenoImager platform's diagnostic capabilities for patient selection could drive adoption in clinical settings, where reliable manufacturing and consistent product quality are paramount.
However, investors should note that success in the IVD market requires navigating complex regulatory pathways and achieving clinical validation. While this manufacturing partnership addresses a important component of commercialization, Akoya must still demonstrate clinical utility and secure regulatory approvals for their diagnostic products.
Long-standing partnership strengthens as both companies target growth in IVD sector
"Argonaut and Akoya have built a trusted relationship over the years," said Wayne Woodard, Founder and CEO of Argonaut. “We’ve successfully supported their Research Use only (RUO) portfolio, and we are thrilled to extend this partnership into the highly regulated companion diagnostic space. Akoya’s innovative solutions in spatial biology are shaping the future of precision medicine, and we are proud to play a role in bringing their vision to life.“
“Our spatial phenotyping technology and PhenoImager platform are demonstrating robust diagnostic capabilities for patient selection,” commented Brian McKelligon, CEO of Akoya. “Our partnership with Argonaut is centered around delivering high-quality IVD products to our clients, manufactured under strict cGMP and ISO 13485:2016 requirements. Argonaut’s deep expertise and reliable systems make them an invaluable partner as we scale to meet the demand of the market.”
“Companion diagnostics are a cornerstone of Argonaut’s commitment to regulated markets, especially in light of evolving FDA requirements,” Wayne Woodard added. “Our agile manufacturing systems, empower organizations like Akoya to reliably and efficiently scale their IVD offerings helping them meet the growing demand for precision medicine solutions.”
Akoya Forward-Looking Statements
This press release contains forward-looking statements that are based on Akoya management’s beliefs and assumptions and on information currently available to Akoya management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements concerning expectations about the potential of spatial biology, the demand for precision medicine solutions, the size of the IVD market, the capabilities and potential of Akoya’s products and services, Akoya’s ability to develop, commercialize and meet the demand for its future IVD offerings, and other statements regarding Akoya’s products and services, its partnership with Argonaut, its future performance and its plans and objectives for future operations.
In some cases, you can identify forward-looking statements by the words “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors are described under "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere in the documents Akoya files with the Securities and Exchange Commission from time to time. The reader is cautioned that forward-looking statements are based on a combination of facts and factors currently known by Akoya and Akoya’s projections of the future, about which Akoya cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent Akoya’s views as of the date hereof. Akoya undertakes no obligation to update any forward-looking statements for any reason, except as required by law.
About Argonaut Manufacturing Services
Argonaut Manufacturing Services is an FDA-registered cGMP contract development and manufacturing organization (CDMO) dedicated to providing custom manufacturing and supply chain solutions for biopharmaceutical and diagnostic companies. Aseptic drug fill / finish capabilities feature state-of-the-art automated equipment for high-yield filling of sterile injectable drugs including biologics, peptides, small molecule, and vaccines. Diagnostic manufacturing capabilities include proprietary lyophilization technology and a spectrum of kitting capabilities. Projects are supported with full analytical quality control services including warehousing and global shipping logistics. Serving innovators in the life science, molecular diagnostics, and biopharma industries, Argonaut provides a wide range of flexible solutions for diverse outsourcing needs. For more information, visit: www.argonautms.com.
About Akoya Biosciences
As The Spatial Biology Company®, Akoya Biosciences’ mission is to bring context to the world of biology and human health through the power of spatial phenotyping. The company offers comprehensive single-cell imaging solutions that allow researchers to phenotype cells with spatial context and visualize how they organize and interact to influence disease progression and response to therapy. Akoya offers a full continuum of spatial phenotyping solutions to serve the diverse needs of researchers across discovery, translational and clinical research: PhenoCode™ Panels and PhenoCycler®, PhenoImager® Fusion, and PhenoImager HT Instruments. To learn more about Akoya, visit www.akoyabio.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250128915202/en/
Argonaut Media Contact
Marianne Woodard
Press and Project Specialist
marianne.woodard@brainspores.com
+1 408-313-8583
Akoya Investor Contact:
Priyam Shah
investors@akoyabio.com
Akoya Media Contact:
Christine Quern
media@akoyabio.com
Source: Argonaut Manufacturing Services
FAQ
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