Commercialization of blood-based genetic testing and lymph node metastasis testing
First written in FY2016. 6 of 11 entries say "Advanced", first in FY2019-Q1. Latest entry: FY2023-Q3.
No other company in this theme has enough history to compare yet.
- FY2023-Q3AdvancedAnnual report
「⑨ In October 2022, the Company obtained approval for a partial change to the manufacturing and marketing approval for the gene amplification detection reagent LinoAMP™ CK19, expanding its indications to lymph node metastasis testing for cervical and endometrial cancer.」
Obtained approval for a partial change to expand the indications for LinoAMP™ CK19 to lymph node metastasis testing for cervical and endometrial cancer. - FY2022-Q2RestatedAnnual report
「The Company obtained European In Vitro Diagnostic Medical Devices Regulation (IVDR) certification for LYNOAMP™ CK19 E, a gene amplification detection reagent based on the OSNA™ method.」
Reposted the European IVDR certification of LYNOAMP™ CK19 E as a research and development achievement. - FY2022-Q1AdvancedAnnual report
「In the life sciences field, LYNOAMP™ CK19 E, a gene amplification detection reagent based on the OSNA™ method developed independently by the Company, obtained European In Vitro Diagnostic Medical Devices Regulation (IVDR) certification (Class C), the first such certification among the Company's products. The Company will continue activities to enhance the clinical value of cancer lymph node metastasis testing and pursue IVDR certification for its IVD products in each field supplied in Europe.」
LYNOAMP™ CK19 E using the OSNA™ method obtained European IVDR Class C certification, the first such certification for a Company product. The Company has indicated its policy of enhancing the clinical value of cancer lymph node metastasis testing and pursuing IVDR certification for other IVD products in Europe. - FY2021-Q2AdvancedAnnual report
「In August 2020, blood-based testing for RAS gene mutations in colorectal cancer using the OncoBEAM™ RAS CRC Kit, which the Company manufactures and markets, became eligible for reimbursement under Japan's public health insurance system.」
Blood-based testing for RAS gene mutations in colorectal cancer using the OncoBEAM™ RAS CRC Kit became eligible for reimbursement, advancing the clinical use of blood-based genetic testing. - FY2020AdvancedAnnual report
「The in vitro diagnostic medical device LinoAMP™ BC obtained regulatory approval from China's National Medical Products Administration (NMPA). The breast cancer lymph node metastasis testing system using the OSNA™ method is the first lymph node metastasis test based on a molecular biological technique to receive regulatory approval as a Class III product in China.」
Obtained China's first regulatory approval for a Class III product for a breast cancer lymph node metastasis testing system using the OSNA™ method. - FY2020-Q2AdvancedAnnual report
「August 2019: We obtained domestic manufacturing and marketing approval for the RAS gene mutation detection kit OncoBEAM™ RAS CRC Kit. It is Japan's first in vitro diagnostic product for RAS gene mutation testing in colorectal cancer using liquid biopsy.」
Regarding the commercialization of blood-based genetic testing, obtained domestic manufacturing and marketing approval for the OncoBEAM™ RAS CRC Kit. - FY2019-Q2RestatedAnnual report
「In May 2018, the Company announced the domestic launch of a new cancer lymph node metastasis testing system using its proprietary OSNA™ method for rapid detection of lymph node metastasis, comprising the gene amplification detection instrument RD-200 and the gene amplification detection reagent LinoAMP™ CK19.」
Reposted the announcement of the domestic launch of the RD-200 and LinoAMP CK19 using the OSNA method as a research and development achievement. - FY2019-Q1AdvancedAnnual report
「In May 2018, the Company announced the domestic launch of a new cancer lymph node metastasis testing system using its proprietary OSNA™ method for rapid detection of lymph node metastasis, comprising the gene amplification detection instrument RD-200 and the gene amplification detection reagent LinoAMP™ CK19.」
Announced the domestic launch of the RD-200 and LinoAMP CK19 cancer lymph node metastasis testing system using the OSNA method. - FY2018RestatedAnnual report
「We will promote market expansion for rapid lymph node metastasis testing using the OSNA™ method.」
The company is reiterating its policy of expanding the market for rapid lymph node metastasis testing using the OSNA method. - FY2017RestatedAnnual report
「We will promote market expansion for rapid lymph node metastasis testing using the OSNA™ method.」
The company is reiterating in its new medium-term management plan its policy of expanding the market for rapid lymph node metastasis testing using the OSNA method. - FY2016First statedAnnual report
「We began operating the OncoBEAMTM RAS CRC Test, a blood-based RAS gene mutation test for metastatic colorectal cancer for research use, at Knappschaftskrankenhaus Bochum, Ruhr University Bochum, in Germany. Our rapid lymph node metastasis testing system using the OSNA method enables results to be obtained in a short time and is expected to improve the accuracy of rapid lymph node metastasis testing for non-small-cell lung cancer and contribute to more appropriate treatment decisions.」
The company describes the start of hospital use of blood-based RAS gene mutation testing and the expansion of the OSNA method to non-small-cell lung cancer.