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Genotox Labs Announced as First Customer for Translational Software’s PGx Interpretation, Integration Service

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Translational Software, a company providing lab services automation and interpretation of genomic test results announced this week that it had booked its first paying customer, Genotox Laboratories.

Genotox has adopted Translational Software’s interpretation services to support the expansion of its new pharmacogenomic testing business focusing on testing for variants associated with metabolism of pain medications.

According to Translational Software’s VP of Business Development Sean Sigmon, companies like Genotox partner with Translational Software because it can help labs with a clinical history but no PGx testing experience transition quickly into offering genetic tests by taking care of clinical interpretation and potentially automating other aspects of the customers' testing and data analysis needs.

“I think this is a step in the right direction toward PGx testing becoming more practical, and potentially more standard of care especially in the pain management world, where Genotox is focused,” Sigmon told PGx Reporter.

In a statement released by Translational Software, Genotox’s founder and director, Mathew McCarty said Genotox’s decision to work with the company was based on a desire to “get to market quickly with a highly scalable business model that will provide superior insights for our referring clinicians.”

Sigmon said that Translational Software has booked five more customers in the last few weeks— most in a similar situation as Genotox: groups with non-PGx clinical laboratory experience that are just now planning to expand to genetic testing.

According to Sigmon, Genotox is using a testing platform from Autogenomics. On its website, Genotox says that the lab offers testing to identify and classify variants in CYP2D6, CYP2C9 (with VKORC1), CYP2C19, CYP1A2, and NAT2 associated with slow, normal, and ultra-fast metabolism of pain and other drugs, including opioids and antidepressants, as well as beta blockers, type I antiarrhythmics, and warfarin.

Sigmon said that Genotox is currently planning to use Translational Software’s web interface to manually enter data that comes from its testing platform and create interpreted reports.

However, he said, Translational Software plans for this process to eventually be integrated into lab information systems to more fully streamline the process. “For the majority of customers that want to scale and grow their operation our foreseeable standard workflow would be that data will come off an analyzer, a laboratory information system would process that into a format the lab prefers for long term storage, and then they would serve it to us ... and we would make reports and send back to the information system for them to interface with the clinician directly.”

Overall, though, Sigmon said, the company sees its most important offering, and the main one that Genotox is taking advantage of, as the interpretation and the creation of an easily actionable report for ordering physicians.

“A lot of clinicians, cardiologists, pain doctors, family practitioners, are really not familiar with the terminology and the nomenclature of the deep life science literature associated with genetic testing … So, they struggle with what to do when they have ordered tests, with incorporating it into their larger practice,” he said.

“And to be fair, the clinical utility of some of these tests … marginal would be a strong word, but it certainly is very personalized.”

While Genotox is starting out from scratch using Translational Software’s interpretation service, Sigmon said the company is also targeting customers who already do their own genomic testing interpretation.

“This is a good example of a lab that is starting pharmacogenetic testing and turned to us to help them scale and provide reports that will be a differentiator for them,” he said. “But our market is really with larger labs that already have market shares in the pharmacogenetic space.”

Although larger labs do a lot of in-house software development "we hope we can become a strong [alternative] resource to hiring and building their own software teams," Sigmon added.

In situations where labs employ multiple pathologists, curating in-house interpretation may also lead to variable or inconsistent reports, and potential risk according to Sigmon. “Our software creates a very consistent and very reliable report,” he said.

According to Sigmon, Translational Software has a scientific due diligence officer who curates the scientific literature that backs up the company’s automated interpretation approach.

Right now, he said the company is prioritizing what its customers want. “A number of customers are doing a lot of similar tests like [CYP] 2C19, so it becomes more of a formatting issue in terms of the report, rather than a knowledge base issue,” he said.

But as labs add new tests, or the science advances on current PGx variants, Sigmon believes the company can quickly integrate new information into the system.

He noted that Translational Software expects its newer customers to start rolling out their PGx programs in the next few months.

He also said the company is exploring strategies to partner with genetic testing technology vendors. “Often times these labs are investing in new equipment and building their businesses around the capabilities of this equipment,” he said.

“So we are working on establishing partnerships in the lab information and equipment provider space," Sigmon said. "We believe we can help them … If we can automate the structure of the report, then it makes for a good consistent proposition for the analysis equipment as well.”

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