Joseph Repp

Joseph Repp, VP, global operations

Achieving CLIA certification remains a critical component to offering clinical assays for the purpose of diagnosis, treatment, or prevention of disease. Beckman Coulter Genomics, Danvers, Mass, which began seeking the certification in January of 2012, recently received both a CLIA Certificate of Registration and Massachusetts State Licensure, allowing the company to begin accepting clinical samples for genetic sequencing. The certifications are the next step for Beckman Coulter Genomics to market its BRAF Sanger-based sequencing assays. Clinical Lab Products recently spoke with Joseph Repp, vice president, global operations, to discuss the process of becoming certified and what this means for the future of the lab.

CLP: Why does the CLIA require certification for genetic sequencing?

Repp: If a laboratory wishes to genetically test clinical patient samples for the purpose of diagnosis, treatment, or prevention of disease, the laboratory needs to obtain CLIA certification. Obtaining certification demonstrates that the laboratory has developed a validated clinical assay that is reproducible, precise, and accurate with established sensitivity and specificity. The laboratory must also show that adequate quality management systems, record keeping, and data tracking procedures are in place to ensure that the likelihood of sample mixup is practically nonexistent. The certification process allows such high-quality standards for clinical sample testing to be enforced nationwide, thereby setting the quality bar higher than research-only grade laboratory standards.

CLP: Can you briefly describe what the CLIA Certificate of Registration allows Beckman Coulter Genomics to do?

Repp: Broadly speaking, the Certificate of Registration allows Beckman Coulter Genomics to be considered a “CLIA-certified lab” delivering services for customers seeking a clearly credible track record of high-quality data generation. More specifically, obtaining the Certificate of Registration means that Beckman Coulter Genomics can legally begin accepting patients’ clinical samples from physicians for the purpose of testing them on our CLIA-certified BRAF Sanger-based sequencing assay.

The company intends to offer CLIA-certified nextgeneration sequencing in addition to offering CLIAcertified Sanger-based sequencing LDTs.

CLP: What was the application process to obtain the certificate? How long did it take? What data/information were you required to supply?

Repp: The application process involved applying for both Massachusetts State Licensure as well as the national CLIA Certificate of Registration from the Centers for Medicare & Medicaid (CMS). These applications began in January 2012, and included identifying key personnel with recognized skills, documenting operating procedures, and the creation of CLIA assay validation plans for our BRAF assay lab developed test (LDT). During the actual CLIA inspection on April 30, 2012, we presented our assay validation experimental results to the inspector and demonstrated the sample workflow in our CLIA laboratory. The final phase of our CLIA application process includes obtaining our CLIA Certificate of Compliance in September after we have tested approximately 30 clinical patients on our BRAF LDT. Lastly, we intend to apply for CLIA licensures in the six additional states that require state-specific licensing so that we can work with any physician regardless of what state their patients reside.

CLP: What role did you play in the certification process?

Repp: The Beckman Coulter Molecular Diagnostic leadership team established a vision to become a global leader in clinical sequencing with a focus on oncology and infectious disease. Reflecting this vision, a dedicated team was created to identify the target, design assays, and work with key customers to earn certification. We have invested accordingly to bring the CLIA-compliant service to address this important market need. This journey has been a true team and company commitment with everyone chipping in toward this goal.

CLP: What are some of the products that you intend on developing with this certification?

Repp: We intend to offer CLIA-certified next generation sequencing in addition to offering CLIA-certified Sanger-based sequencing LDTs. We have begun the process of CLIA validating the sequencing portion of our next-generation sequencing pipeline. We are assessing next steps such as sample preparation and bioinformatics portions of the pipeline, including more broad-based LDTs such as exome capture as well as custom-designed LDTs for specific biomarkers reflecting our customer needs. Beckman Coulter also has a presence in the companion diagnostics and medical device markets, so we have the means as a company to enable the evolution of a customer’s biomarker to progress from LDT to a companion diagnostic run on a Beckman Coulter medical instrument.

CLP: What role did Beckman Coulter Genomics’ existing Quality Assurance Program play in the process of obtaining this certification?

Repp: Our existing Beckman Coulter quality program demonstrated a strong foundation of compliance and data integrity. This foundation allowed us to effectively add the incremental rigors associated with CLIA certification. We also leveraged our relationship with an experienced CLIA consultant to expedite our successful audit compliance.

CLP: When do you expect some of these new assays and services to be available to customers?

Repp: We are already undergoing early access discussions with some of our customers, such as other CLIA labs that need CLIA-certified Illumina sequencing service providers. We intend to have select CLIA next-generation sequencing services available for our customers by fall 2012.

CLP: How will this change the way the company interacts with physicians?

Repp: In the past, we have primarily been focused on serving the needs of those customers seeking research-grade sequencing. Going forward, we are pleased to be able to offer clinical-grade sequencing services to a new physician customer base.

CLP: Finally, can you discuss the recent acquisition of Beckman Coulter Genomics’ North Carolina facility by ILS?

Repp: Beckman Coulter Genomics sets the standard for delivering expert genomics solutions to life science and health care businesses as well as academic and government institutions worldwide. By providing technical expertise, combined with personalized service, Beckman Coulter Genomics delivers the highest quality data, robust analyses and innovative thinking. The recent acquisition of Beckman Coulter Genomics’ North Carolina facility by ILS does not affect Beckman Coulter Genomics. We reviewed options to support our associates and colleagues, with respect to employment. ILS was looking to expand, so ILS and Beckman Coulter Genomics hit a mutual crossroad at the same time. As we continue to focus on our customers, consolidating affords us greater ability to serve.

Chris Gaerig is associate editor for CLP.