human-biospecimens

Frequently Asked Questions

The information below addresses frequently asked questions about our Japanese clinical biospecimens and doing contract research studies with us. You can click on the question links to jump to the relevant answer and comments. You are welcome to contact us if any information you need is not included here, we’ll be glad to help.


TISSUES

From where do you source your tissues ?
How do you ensure tissue quality ?
How is the use of tissue specimens approved ?
How long does study authorization take ?
Can you transfer tissues to us ?
Can you loan us stained IHC slides ?
Can our tissue specimens be included in a study ?
Does Japanese pathology differ from the US / Europe ?
Are normal control tissues available ?

IHC STUDIES

What instrumentation is used for IHC staining ?
Can you use IHC diagnostic staining kits ?
Where is the experimental work performed ?
How do you evaluate IHC staining results ?
In what language(s) can reports be provided ?

OTHERS

Can you tell me about pricing and timelines ?
What legal documentation is required ?
Can you import biomaterials into Japan ?
Can you perform services other than those listed ?
 

CATEGORY >> TISSUES

From where do you source your tissues ?

The tissue specimens in our biobank are accessed from multiple Japanese medical institutions, including some of the biggest and best in the country. As a Japanese company with staff involved in the human biomaterial research area for more than 15 years, we have built strong relationships with these institutions over an extended period of time. Due to confidentiality obligations, we cannot divulge the identities of individual medical institutions.

How do you ensure tissue quality ?

Tissues to be used in a study are stained with hematoxylin and eosin (H&E), and / or other specialized stains, and microscopically examined by a pathologist. This ensures that the histological features of the specimen match the medical diagnosis, as well the needs of the study. For example, the study objective may require that certain tissue structures be present. Only tissue samples with good cellular and structural architecture are selected for use. If the sponsor wishes, staining for antigen preservation markers (e.g., vimentin, CD34, etc.) can also be performed. In the case of cancer tissues, the pathologist grades the actual specimens to be used in the study (we do not depend on the grade stated in the medical records).

How is the use of tissue specimens approved ?

We have overarching agreements with each of our partner institutions authorizing molecular analysis studies on residual archived specimens. Nevertheless, each individual study must be approved by the relevant Institutional Review Board (IRB), and formally authorized by the head of the supplying department (typically the head of pathology). Note that tissue samples are linked, so with the necessary approvals, we can obtain follow-up information on the donor at a future point in time.

How long does study authorization take ?

For a straightforward study where archived tissue is used and donor information is sourced from pathology reports, authorization typically takes 1-2 weeks. For more involved studies (for example, where prospective collection of samples is required, or where access to the donor’s electronic medical record is necessary), approval can take up to several months depending on what is being requested. Studies which involve shipping clinical specimens to the sponsor also require more time for approval.

Can you transfer tissues to us ?

Transfer of biobank specimens to sponsors outside of the context of a contract research study is not possible. Even when we can provide materials as part of a study, the amounts that can be transferred are decided on a case-by-case basis by the relevant institution, and in our experience are likely to be limited.

Can you loan us stained IHC slides after a study ?

Yes. It is possible to loan you the stained IHC slides following the conclusion of a study. The loan period is typically 4 weeks, but can be longer if it is necessary.

Can our tissue specimens be included in a study ?

Yes. We can use tissues provided by you or from a commercial source, so long as the tissues have been ethically collected. We often use such “outside” tissues to compare the gene expression profile of different ethnicities / populations. We also often use sponsor-provided materials (cell lines, etc.) as experimental controls.

Does Japanese pathology differ from the US / Europe ?

Yes, there are differences. The classification of disease progression can differ significantly, depending on the disease in question. Although the trend in recent years is towards harmonization of pathology evaluations between the US, Europe and Japan, many differences remain. Our pathologists are familiar with US / international grading and staging standards, and can ensure that the selected tissues meet your requirements exactly.

Are normal control tissues available ?

Yes. Our biobank includes material from more than 25,000 autopsies. If surgical material is desired, many normal adjacent tissue (NAT) specimens from cancer and benign conditions are available.

CATEGORY >> IHC STUDIES

What instrumentation is used for IHC staining ?

The available equipment depends on the collaborating medical institution but in general automatic stainers such as Ventana and DAKO instrumentation are used. We can accommodate both standard and custom (including manual) staining protocols.

Can you use IHC diagnostic staining kits ?

Yes. We can source IHC clinical diagnostic staining kits (e.g., Ventana, DAKO, etc.), or use your kits if you wish to provide them.

Where is the experimental work performed ?

IHC studies are performed in the certified clinical diagnostic testing laboratories of our collaborating Japanese medical institutions. Non-IHC studies may be performed at other research institutes in Japan.

How do you evaluate IHC staining results ?

The intensity of staining in the sponsor’s cell types and / or tissue structures of interest is recorded, as well as whether the staining is membrane or cytoplasmic. Staining intensity is evaluated using a semi-quantitative scoring system, typically from 0 to 3. The scoring system is agreed upon with the sponsor prior to initiation of the study. We can work with you to create custom evaluation schemes if required.

In what language(s) can reports be provided ?

Study reports can be provided in either English or Japanese.

CATEGORY >> OTHERS

Can you tell me about pricing and timelines ?

All our studies are custom-designed, so pricing and timelines will vary depending on study characteristics. In general, factors such as the number of donors, necessary donor annotations, analysis methodology, and whether the provision of samples to the sponsor is requested, influence pricing and timelines. We are happy to provide pricing and timeline information as part of a study proposal, once we understand your requirements.

What legal documentation is required ?

We usually sign a mutual confidentiality agreement at the onset of discussions in which sensitive information needs to be disclosed. It is necessary to execute a contract research services agreement to proceed with studies, and we can provide a template once there is a decision to move forward. The sponsor also signs off on a study proposal containing the relevant technical details and other information.

Can you import biomaterials into Japan ?

Yes. We have over 12 years’ experience of importing biomaterials into Japan (human tissues, antibodies, proteins etc.) and are fully conversant with customs requirements and import procedures.

Can you perform services other than those listed ?

It may be possible to perform other services relating to biospecimens, depending on what you need. Once we understand requirements, we will be happy to investigate feasibility.