TEST:

GenesWell BCT

A cost-effectiveness evaluation comparing the widely used ODX with BCT revealed that BCT is the dominant option in South Korea.

Patients receive palbociclib 125mg once daily for 21 days of 28-day cycle plus tamoxifen or aromatase inhibitor (anastrozole, letrozole or exemestane) once daily for every day. Significance level is 0.025, power is 0.80. Considering 10% drop out rate, 4-years of accrual patient enrollment and 3-years of follow up period, 578 patients were required in this clinical trial.

"The results of the Korea-Japan joint clinical study announced at GBCC last April were published in a paper...This study succeeded in demonstrating the excellent performance of Geneswell BCT not only in Korea but also in Japanese patients, and showed that the prognosis prediction period is possible up to 15 years."

"Gencurix's breast cancer prognostic diagnosis 'Ginswell BCT' has applied to 4 new hospitals. Including this new hospital, a total of 54 medical institutions nationwide will provide GenesWell BCT services...The number of hospitals adopting Geneswell BCT has been steadily increasing since prescriptions for general medical treatment became possible in mid-April."

The BCT score can identify patients at low risk for recurrence who may not require adjuvant chemotherapy or extended endocrine therapy, regardless of age.

"Gencurix...announced...that the Korea Health and Medical Research Institute (NECA) has additionally approved hospitals to introduce the 'Ginswell BCT' test service for breast cancer...As Geneswell BCT became available for prescription for general medical purposes in mid-April, more hospitals are introducing it."

"Gencurix announced on the 5th that six hospitals in Korea have newly applied for the introduction of 'Ginswell BCT'...a prognostic diagnosis service for breast cancer...Gencurix will provide Geneswell BCT service at a total of 50 medical institutions nationwide, including six newly introduced locations. According to Gencurex, Geneswell BCT has been available for prescription for general medical purposes since last April, and more hospitals are introducing it."

"Gencurix...announced the release of clinical research results directly comparing the accuracy of its breast cancer prognostic test, GenesWell BCT, with Oncotype DX, the globally top-selling test, confirming its outstanding performance....The results revealed that GenesWell BCT demonstrated a superior prognostic performance in accurately distinguishing high-risk and low-risk groups, with a Hazard Ratio of 2.469 for high-risk recurrence compared to 2.093 for OncotypeDX. This difference in favor of GenesWell BCT was even more pronounced in subgroup analyses based on lymph node metastasis."

"Gencurix announced...that 11 organizations applied for the use of Geneswell BCT to the Korea Health and Medical Research Institute (NECA) at the end of March and received final approval. The Korea Health and Medical Research Institute is an institution under the Ministry of Health and Welfare, and manages innovative medical technology implementation institutions."

"Gencurix...announced...that it would present the results of prognostic diagnosis clinical trials conducted on 366 Korean and Japanese breast cancer patients at the World Breast Cancer Conference (GBCC) to be held in Seoul...Gencurix's 'Ginswell BCT' was used to predict the prognosis of breast cancer...83.6% were classified as low-risk and 16.4% as high-risk. Clinical results showed that patients in the low-risk group had a significantly higher survival rate after surgery than those in the high-risk group."

We found that the BCT score was useful in stratifying the risk of relapse in chemotherapy-untreated patients with a low recurrence score (RS). This indicates that the BCT score could provide additional clinical value in identifying patients with a long-term risk of relapse, particularly in young women with an RS of 21 to 25.

"Gencurix selected as the topic of presentation at the American Society of Clinical Oncology (ASCO) the results of a clinical study that directly compared the accuracy of its breast cancer prognostic test, Geneswell BCT, and Oncotype DX, the global top seller..."

No abstracts available

"Gencurix announced...that it completed the registration of 600 patients for PMS and innovative medical technology research and expanded the coverage of breast cancer prognosis diagnosis service in earnest. As a result, most general hospitals can freely use Geneswell BCT for medical purposes without participating in clinical studies."

"Gencurix...announced on the 8th that it has completed the Japanese patent registration of 'Ginswell BCT', a breast cancer prognosis diagnosis product developed with its own technology. The patent is a technology that predicts a patient's risk of recurrence and metastasis by measuring the expression value of a specific gene in breast cancer tissue...Based on this patent registration, Gencurix plans to speed up the approval of 'Ginswell BCT' from Japan's Ministry of Food and Drug Safety (PMDA)."

"Gencurix announced on the 18th that it had introduced breast cancer diagnosis products to major hospital officials at the Breast Surgery Society 'Breastanbul 2022' held in Turkiye...Gencurix held a Geneswell BCT product briefing session for breast cancer specialists at Liv Hospital, Medicana Hospital, and American Hospital, including Acibadem Hospital, which represents Turkey."

"Gencurix...announced on the 2nd that it had participated in the 'World Breast Cancer Conference GBCC 2022' and promoted 'Ginswell BCT', a prognostic test for breast cancer...Geneswell BCT is the first and only breast cancer prognostic diagnostic test in Asia that has obtained official approval from the Korean Ministry of Food and Drug Safety. Numerous clinical trials have proven that patients classified as low-risk through the test have a high survival rate with or without chemotherapy."

"To better delineate the relapse risk in these populations, it is necessary to develop a multigene assay and validate it in a cohort comprising a higher proportion of young patients.Several multigene assays have been developed and are being used in Asian countries, including the Curebest 95 in Japan, the RecurIndex in Taiwan, and the GenesWell BCT and OncoFREE in Korea. The characteristics and clinical evidence of these multigene assays will be introduced in comparison to those widely used globally, such as the Oncotype DX, Mammaprint, Endopredict, and PAM50."

"Gencurix...announced...it had received approval for the use of 'Ginswell BCT' in 28 general hospitals as of the end of last month by the Korea Health and Medical Research Institute (NECA)...Geneswell BCT is a breast cancer prognostic diagnostic test that predicts the prognosis of breast cancer patients through genetic analysis and classifies patients into low and high risk groups to inform whether they need chemotherapy treatment. Gencurix received approval from the Korean Ministry of Food and Drug Safety in 2017..."

"Gencurix...will apply for clinical trial approval (IND) for Geneswell BCT, a breast cancer prognostic diagnostic tester, to the Japanese Ministry of Health in the first half of next year. Gencurix is ​​a molecular diagnostic analysis platform solution company...'Based on the clinical trial results of the Geneswell BCT study conducted at a Japanese hospital, we will publish a thesis in a prominent local academic journal in the first half of next year.' We plan to proceed with clinical trials for approval (PMDA).'"

"Liquid biopsy molecular diagnostics company Gencurix announced on the 6th that it has finally registered a US patent for methods for predicting risk of recurrence of breast cancer patients...The patent is about the biomarker and algorithm technology of Geneswell BCT independently developed by Gencurix."

The BCT score could be used to identify low-risk patients who will not benefit from adjuvant chemotherapy to treat HR+/HER2- early breast cancer regardless of age. A further prospective study to assess the prognostic and predictive value of the BCT score is required.

P; N=100; Not yet recruiting; Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University