Osaka University Hospital Clinical Sequence Laboratories have been accredited by CAP-LAP
Osaka University Hospital began on October 1 a program that comprehensively analyzes the cancer genome in samples from patients with refractory solid tumors. This is the third such program approved in Japan under the framework Advanced Medical Care*1. Analysis using cancer gene panels*2 from the OncomineTM Target Test System*3 will be conducted in a CAP-LAP*4 accredited facility.
In general, cancer treatments are based on histological analysis of the diseased tissue. Ultimately, however, patients show a wide range of responses to the treatment, because the cancer genome can be very different between patients even for the same affected organ . In recent years, several drugs have been developed which target specific genomic altarations. To evaluate predict the effectiveness, companion diagnostics*5 are performed as a part of clinical practice. Next generation sequencing*6 has reached a stage where it can be used to analyze multiple genomic abnormities in a very short time. Applying this technology to the cancer genome, it is expected that faster and better selection of drugs for individual patients is possible (i.e. personalized medicine).
In April of this year, the Ministry of Health, Labour and Welfare designated Osaka University Hospital as a Core Cancer Genome Centre compliant with CAP-LAP, thus meeting international standards for the use of cancer gene panels. Through further research using these panels, the hospital aims to provide better cancer care at lower cost within a framework of subsidies from the national health insurance.
Cancer Gene Panel Analysis at Osaka University Hospital
・A small panel of 46 genes targets is prepared
・Analysis of DNA and RNA to expand the number of detected genetic abnormalities including fusion genes
・High-speed analysis at a CAP-LAP accredited facility inside the hospital
Outline of the project
・Study name: Cancer gene panel test for patients with refractory solid tumors
・Study design: Single group study
・Scheduled period: 18 months beginning October 1, 2018. 12 months registration, 6 months follow-up
・Number of cases expected: 200
- Diagnosis of pathological solid cancer (blood tumors and sarcomas are excluded)
- Inoperable Stage III/Ivor refractory cancer （standard treatment is unavailable, completed, or soon to be terminated）
- Over 16 years of age
- Overall good condition
- An initial effect can be determined with standard medications
- A cancer biopsy sample is available for the cancer gene panel
【Genes to be tested】
Percentage of patients with measurable genetic abnormalities that have clinical significance including prognosis, diagnosis, treatment strategy (all eligible cases).
(1) Percentage of patients with a gene abnormality (all registered cases, all qualified cases)
(2) Success rate of sequencing
(3) Frequency of each cancer gene abnormality
(4) Percentage of domestic clinical trials corresponding to gene abnormality in all qualified cases
(5) Percentage that received a therapeutic agent
(6) Overall survival
Patient cost is 245,000 yen （the total cost is 445,000 yen, and Osaka University will cover approximately 200,000 yen ）.
Note that Osaka University only provides medical services covered eligible for national health insurance subsidies (mixed medical economy*7 is prohibited).
(1)Advanced medical care
Innovative medical treatments that satisfy certain safety and efficacy criteria but not necessarily approved for subsidies by the national health insurance but. Subsidies include costs incurred for the examination, hospitalization, etc. The program at Osaka University will only be third cancer gene panel eligible for subsidies in Japan.
(2)Cancer gene panel
Used to analyze multiple cancer genes simultaneously from a patient sample.
(3)Oncomine Target Test
A commercial cancer gene panel that has received approval from the Japan Ministry of Health, Labour and Welfare.
The U.S. College of American Pathologists (CAP) has set up the Laboratory Accreditation Program (LAP), which is an accreditation program recognized around the world for clinical laboratories. Osaka University was certified August 7, 2018.
Tests are used to predict which patient populations are likely to respond positively to a drug, because patients respond differently based on the type of gene abnormality.(6
(6)Next generation sequencers
Technology that can analyze hundreds of millions of base sequences in a short time.
(7)Mixed medical economy
The combination of publically insured and uninsured medical treatments is known as mixed medicine and is generally prohibited.