With 100% accuracy and 100% specificity, Generize’s genetic testing laboratory received the highest rating in the College of American Pathologists (CAP) proficiency testing program

The genetic testing laboratory operated by Generize Co.,  Ltd. (Headquarters: Room 307, Chiba University Inohana Innovation Plaza, 1-8-15  Inohana, Chuo-ku, Chiba City, Chiba Prefecture; Representative Director:  Junichi Hosokawa) has participated in the "NGS-A 2026" program —  which focuses on germline mutation analysis using next-generation sequencing  (NGS) — offered as part of the proficiency testing program (CAP Surveys)  provided by the College of American Pathologists (CAP). We are pleased to  announce that, in the evaluation dated August 11, 2026, the laboratory achieved  100.0% accuracy in variant detection (Correct Variant Assessment) and a  specificity of 100.0%, earning an overall rating of “Good” (the highest  rating).

CAP Surveys is an external quality assessment program in  which clinical laboratories from around the world participate. Participating  facilities report the variants (genetic mutations) they detect in a common set  of samples; in addition to an evaluation of their accuracy, the program  provides statistical comparison results within a peer group of facilities using  the same reagents and sequencers. Through our participation in this program in  the field of genetic disease testing, our laboratory has objectively verified  both the accuracy of our variant detection results and our level of testing  precision compared to similar testing facilities in Japan and abroad.

The evaluation covered 48 variants in the "NGS-A  2026" program (CAP Number: 7814583-01, Kit Number: 40910991), all of which  received an "Acceptable" rating.

Our laboratory has set CAP accreditation as a future goal  (targeted for 2027–2028), and our participation in this survey is part of our  efforts to strengthen our quality management system toward achieving that goal.

[About Our Laboratory]

Our laboratory has established a system that allows us to handle the entire process—from specimen receipt to analysis and the preparation of the final report—in-house without outsourcing any steps, enabling us to perform testing for hereditary diseases.Regarding specimens, in addition to collection via the non-invasive iSWAB (buccal swab), we have also begun accepting blood specimens collected through venipuncture, allowing patients to choose the optimal collection method based on their condition and the purpose of the test.In particular, since iSWAB does not involve blood collection, it places minimal physical burden on patients, and because collection and transport are straightforward, it enables testing in a wide range of settings, including for elderly patients, children, and home healthcare settings.This CAP survey is one of our initiatives to objectively verify, against international standards, the accuracy of the test results provided under this integrated system.

[Comment from Junichi Hosokawa, Representative Director]

“Through our participation in this CAP Survey, we were able to objectively confirm that our laboratory’s NGS-based mutation detection results meet international accuracy standards, as evidenced by a mutation detection accuracy of 100% and a specificity of 100%. We will continue to refine our quality management system as we work toward obtaining CAP accreditation.”

[About CAP Surveys (Proficiency Testing Program)]

This is an external quality assessment program for clinical laboratories provided by the College of American Pathologists (CAP), in which laboratories worldwide participate to mutually compare and verify the accuracy of their test results.

[Company Overview]

Company Name: Generize Co., Ltd.

Address: 1-8-15 Inohana, Chuo-ku, Chiba City, Chiba Prefecture

　　　　　　 Room 307, Chiba University Inohana Innovation Plaza

Representative Director: Junichi Hosokawa

Business Activities: Genetic testing services, bioinformatics analysis

URL: https://generize.co.jp/en/top/