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Posted On: 07/07/2025 7:50:10 PM
Post# of 96
Bionano Genomics OGM - Worldwide
EUROPE: Conformité Européenne marking confirms that a diagnostic device meets the European Union’s standards. Bionano has submitted its genome‐mapping system and accompanying test kits for this marking, enabling hospitals and independent laboratories across Europe to use the technology for patient diagnosis rather than research alone. Receipt of this approval would allow routine testing of structural genetic variants in clinical settings from SCANDINAVIA to southern FRANCE, accelerating adoption in hereditary disease screening and oncology.
JAPAN: Bionano’s submission dossier detailing analytical performance, clinical validation and risk analysis is under review, paving the way for official clearance.
CANADA: In Canada, Health Canada approval involves a detailed review of device safety and clinical utility. Bionano has initiated the application process to secure this license.
AUSTRALIA: In Australia, the Therapeutic Goods Administration oversees diagnostic device listings. Bionano’s system is being evaluated under the higher‐risk category for in vitro diagnostic use.
CHINA: Engagement with China’s National Medical Products Administration commenced with a technical consultation, defining the performance metrics required for clinical claims. Approval here would tap one of the world’s largest genomic‐testing markets, allowing regional laboratories to offer high-resolution structural‐variant testing for oncology and rare diseases.
Why These Approvals Matter
Each new country license reduces regulatory risk, making Bionano’s technology a globally recognized standard for clinical genome mapping. Widespread approval underpins partnerships with local distributors, laboratory networks and regional centers of excellence, driving recurring revenue through consumable kit sales.
EUROPE: Conformité Européenne marking confirms that a diagnostic device meets the European Union’s standards. Bionano has submitted its genome‐mapping system and accompanying test kits for this marking, enabling hospitals and independent laboratories across Europe to use the technology for patient diagnosis rather than research alone. Receipt of this approval would allow routine testing of structural genetic variants in clinical settings from SCANDINAVIA to southern FRANCE, accelerating adoption in hereditary disease screening and oncology.
JAPAN: Bionano’s submission dossier detailing analytical performance, clinical validation and risk analysis is under review, paving the way for official clearance.
CANADA: In Canada, Health Canada approval involves a detailed review of device safety and clinical utility. Bionano has initiated the application process to secure this license.
AUSTRALIA: In Australia, the Therapeutic Goods Administration oversees diagnostic device listings. Bionano’s system is being evaluated under the higher‐risk category for in vitro diagnostic use.
CHINA: Engagement with China’s National Medical Products Administration commenced with a technical consultation, defining the performance metrics required for clinical claims. Approval here would tap one of the world’s largest genomic‐testing markets, allowing regional laboratories to offer high-resolution structural‐variant testing for oncology and rare diseases.
Why These Approvals Matter
Each new country license reduces regulatory risk, making Bionano’s technology a globally recognized standard for clinical genome mapping. Widespread approval underpins partnerships with local distributors, laboratory networks and regional centers of excellence, driving recurring revenue through consumable kit sales.
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