Building a Lab

MolecularHealth, a treatment decision support services company, is building its own NGS laboratory

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The rise of genetic sequencing in recent years has given birth to a whole new kind of clinical laboratory. As our ability to look at the human exome and decode the human genome has improved, the technology we use to analyze DNA has become extremely sophisticated, producing more information and requiring more time for the analysis of increasingly vast amounts of data. In many clinical laboratories, healthcare professionals are doubling as technicians and bioinformatics workers in an effort to better -- or, at least, more quickly - understand the results of their tests.

In a recent interview with ADVANCE, Shelly Gunn, MD, PhD, chief medical officer at MolecularHealth, a treatment decision support services company in the process of building their first next-generation sequencing (NGS) laboratory, discussed the obstacles of putting together a clinical lab. MolecularHealth decided to incorporate its own NGS testing services having started out in bioinformatics and, as such, already had access to the most recent post-sequencing technology available. Gunn was tasked with heading up the introduction of the company's NGS laboratory in Texas.

"I was so excited to finally find a solution to that problem that all of us have faced in trying to introduce NGS testing into the clinical laboratory in that we generate tremendous amounts of data," said Gunn. "And we can do it quickly and cheaply now, but once we have the data, translating that into clinically actionable results for the patients has been a challenge."

Before building their own NGS laboratory, MolecularHealth produced tools for increased efficiency in the interpretation of genetic data. According to Gunn, the company aimed to bring together multiple databases for the easiest possible transition from test results to "clinically actionable" information - essentially ensuring the post-testing process was as efficient as possible before entering the testing side of the equation. While this means the new laboratory will be late to the game in terms of NGS testing assays, so to speak, having the analytical process smoothed out already allows the sequencing process to work backwards and prevent potential mistakes ahead of time.    

"Obviously, we're developing a clinical laboratory and, once that decision is made, then of course you're going to have to - just like any other CLIA [Clinical Laboratory Improvement Amendments] certified lab - choose an accrediting agency," continued Gunn. "So, of course we chose the College of American Pathologists [CAP] because their recommendations and inspection processes are also, really, a blueprint for how to build out an NGS lab."

As genetic sequencing has become more and more commonplace in clinical testing, the process of building a laboratory is extensively thought-out and involved.  Gunn noted the importance of several decisions that have to be made early in development, including the choices of accreditation agencies and what tissue sources are accepted; so the process, from a sample to a reported result, is both efficient and clinically actionable.

"Beyond that, we depend on software that can actually interpret, either through the germ line analysis of a patient or inferred germ line analysis, what biomarkers may be associated with adverse responses to drugs that are recommended based on somatic tumor biomarkers," explained Gunn. "So, having proprietary software is an incredible tool, and I think the differentiator, really, for MolecularHealth in that the bioinformatics were there before the lab."

Additionally, the implementation of electronic health records (EHRs) has gone hand-in-hand with genetic sequencing and increased the speed in which results are communicated between departments and even facilities within a health system. Gunn went on to mention some things she would like to see in terms of the future of clinical testing, discussing anatomic pathology practices as vital to the progress and growth of NGS testing. She talked about their growing role in "taking it as far as an anatomic pathology practice can go without necessarily bringing the machines in-house," and singled out cancer research as particularly significant. 

"The thing I would most like to see is involvement of my colleagues in offering NGS testing, either through our lab or taking the next step in molecular testing when they have a case where single gene and even multiplex gene analysis in particular for metastatic cancer patients is not providing answers that are clinically actionable," said Gunn. "In these types of scenarios, pathologists can proactively introduce NGS testing as an option to the clinician and participate by sending the tissue block or unstained slides to a reference laboratory. Pathologists who want deeper interaction (without having to bring expensive sequencing technology into the lab) can perform the tumor targeting, microdissection, and DNA extractions. With this approach, the patient's tumor tissue remains with the pathologist and only DNA is sent out for testing.  These basic pathology steps are reimbursable and introduce a potential new source of revenue for the laboratory."

NGS testing is an area of the healthcare industry that is continually growing. As such, it has sparked a significant number of new clinical facilities and laboratories specializing in the state-of-the-art testing service. Companies like MolecularHealth, which started out focused on the interpretation of the raw data obtained during testing, are now trying their hand in the processes and assay involved in clinical testing and are introducing an altogether different type of NGS laboratory. These laboratories could potentially improve both the results as well as the way those results are interpreted, allowing for better efficiency, accuracy and understanding of our genetic makeup.

Michael Jones is on staff at ADVANCE.


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