We sat down with CEO of Macrogen Corp, Sang Tae Park; Dr Carlos Ruiz, Medical Director; and Jung Kim, Director, Clinical Services, at ASHG. We spoke to them about their latest CAP accreditation, and what benefits this will bring them in the next year.

Could you tell me about your recent CAP accreditation?

Dr. Carlos Ruiz: 20-30 years ago there were problems with tests that were not done well, and there was mortality because of that. The US government decided to regulate that and create a law known as CLIA, the Clinical Laboratories Improvement Act of 1985. This law sets standards for how tests should be done so that the quality of tests are even and appropriate for the person. One of the things that CLIA says is that every laboratory that is going to perform testing in human beings in the US, that will influence the diagnosis, treatment or outcomes of that person, needs to be under the guidance of CLIA laboratories. CLIA is like the baseline responsibility of the government, to say listen guys, you need to do this otherwise you can’t do anything to humans in the United States. What has happened since then is that most of the respectable labs have adopted this message. So in today’s marketplace it is almost expected that if you are reputable laboratory you are going to be certified by CLIA.

CLIA is an organisation that manages CMS along with the FDA, and they don’t have enough people to check out all the laboratories across the United States. So what they do is delegate different organisations to go and check and make sure that what laboratories are saying they are doing is the truth. There are four main organisations: CMS itself can do it, COLA can do it, CAP can do it and A2LA can do it. Macrogen Clinical Lab has been certified by CLIA for a number of years but the certification was obtained via CMS. So, CAP is considered to be the golden standard because it is an organisation created, managed, exploited, loved and hated by physicians, PhD’s. If you have a CIA approval by one of these companies then it is considered you are doing a good job. This is what we did with Macrogen, we were able to get the CLIA certification years ago, and when we talked to others in managerial positions we decided we were going to have the highest standard that we could, so we worked for quite a long time until we were able to get this. When we went through the process, we had a few observations but we were able to pass with no problems. Nowadays, Macrogen Clinical Lab has the approval of the federal government on the CLIA and the accreditation given by CAP.

What are the benefits of achieving a gold standard?

Sang Tae Park: The first one is the eligibility to contribute to a diagnosis in the US, in which the CLIA/CAP is a requirement. The problem in the genomic market is that it is still not fully ready because of reimbursement. With CLIA and CAP we can extend our services more to many other areas.

Dr. Carlos Ruiz: It is a strenuous process and it requires a lot of work and money. If you were to look at it from the point of view of the consumer, we can offer them the best quality they could ever ask for. It provides the company the best they can ask for, so that they will feel comfortable sending their work to us, as they know we will produce quality work.

 What feedback have you received about this at ASHG?

Jung Kim: That we can be trusted. This is a very big step for us. We can guarantee the highest quality of service for the customer. Our clients can trust our services no matter what circumstances they send samples from, we are able to provide them with the same quality of data every time. I think that we can build trust between the customer and the service provider, which enables us to pick up new business. Other regions, such as Europe and Asia, know that we are CLIA and CAP certified, assuring them that our lab will carry out tests under the proper policy and protocols with necessary requirements.

Dr. Carlos Ruiz: We can give them the reassurance that what we are doing is done the proper way, and we can give them that information with confidence.

How does this set you apart from your competitors?

Dr. Carlos Ruiz: This is the main emphasis in having the certification. In Europe there is another certification, called ISO. This doesn’t have a lot of practical relevance in the US. At some point we would like our two Seoul laboratories to be CLIA, CAP and ISO accredited as well. We will then be in a very good position.

Sang Tae Park: We stand out for quality and our main aim is to maintain that every year. Our next step is to combine ISO accreditation as well.

What are some of your key areas of focus right now in the Asian market, and what are the challenges you face within this?

Sang Tae Park: If you are talking about the Asian market specifically, then out of our global headquarters in South Korea, we are working on various research projects. Currently, we are also preparing for a healthcare- and diagnostic-based business. All of the genomic data is based on location; we are working on preparing projects that are based on that understanding.

Dr. Carlos Ruiz: Macrogen in Asia has an extremely large library of information and Dr. Seo [Chairman of Macrogen, Inc.] has been very diligent about building that. We are working to eventually bring together everything, and make on big gigantic solid organisation that will provide good work on both sides of the world.

Is there anything else you want to mention?

Sang Tae Park: One of the things our CAP accreditation has allowed is whole genome sequencing (WGS) in a CLIA/CAP setting. I think more work in this area is a great step to get the highest quality.

We want to get a better understanding of precision medicine; everyone has a different genome and based on this we need to understand population genomics. We are really proud to have a whole genome accreditation with CAP and CLIA. We are really excited about the future!