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Invivoscribe Enters Bioinformatics Market, Hires First CIO

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CHICAGO – Molecular diagnostics company Invivoscribe is branching out into bioinformatics by hiring its first-ever chief information officer and introducing a new bioinformatics platform.

San Diego-based Invivoscribe last week debuted its commercial version of LymphoTrack, an enterprise pipeline management system for high-volume clinical molecular laboratories to access raw sequencing data, mine data from CDR3 — a key T-cell receptor region for measuring clonal expansion in leukemia — and interpret results through visualization.

LymphoTrack is currently only compatible with Illumina MiSeq instruments, but the firm will soon introduce B-cell MRD clonality and MyMRD-myeloid assays through its international LabPMM network for Illumina NextSeq 550Dx and NovaSeq sequencers. Invivoscribe said that the two MRD services will be available for research studies by the end of the year and that the company expects CAP/CLIA accreditation for the assays in early 2022.

Tony Lialin, the company's chief commercial officer, said that in general, Invivoscribe's technology is "platform-agnostic," since the company has kits that run on Thermo Fisher Scientific Ion Torrent sequencing, as well as on capillary electrophoresis instruments.

LymphoTrack represents the commercialization of bioinformatics technology the company had developed for managing its own internal pipelines. Lialin called software "a hugely undervalued asset at Invivoscribe."

Lialin joined Invivoscribe in March after serving as CCO of Loop Genomics for three years. Earlier, he helped found Silicon Genetics and BlueGnome, informatics-focused companies that were acquired by Agilent Technologies and Illumina, respectively.

When he came on board at Invivoscribe, Lialin "saw a ton of software that we can potentially commercialize [and] productize that would add value to what our customers are doing," he said this month.

"We were just looking at what we have and asking the question if we've developed all these processes internally to help us get to the answer, why don't we do this for our customers? It just makes sense," Lialin said.

"I really think there's a lot of value through informatics, and I always gravitate towards it," Lialin added. To him, bioinformatics software can alleviate bottlenecks in both collecting clinical samples and in analyzing the data from molecular lab tests.

"If we have tools that can assist our customers, why not get them out there into their hands?" Lialin said.

The company plans on further automating pipelines by adding artificial intelligence and machine learning to its software. That is the wheelhouse of Meindert Niemeijer, chief information officer, who joined Invivoscribe at the beginning of last week after working in R&D at Coralville, Iowa-based Digital Diagnostics, an AI-based medical diagnostics company.

At Digital Diagnostics, Niemeijer worked in a hybrid environment where software was both embedded in medical devices and hosted in the cloud. He said that he would like to investigate more cloud deployments for Invivoscribe software.

"I think it really is important for us to take a good look at that data and see what value we can derive from that," Niemeijer said. "Whenever you have people looking at complex data for a long amount of time, those are the kind of areas that are really ripe for … AI."

Lialin said that Invivoscribe has generated more data this year than in the entire 25-year history of the company prior to 2021.

The company has had a software development team for several years, building Java-based apps for desktop computers for specific clinical trials or to bundle with companion diagnostics. "It allows people to bring data in at a small scale and click through and get results," Lialin said.

Until now, though, Invivoscribe has lacked software for high-throughput environments. It certainly did not have a comprehensive informatics strategy that would necessitate the hiring of a CIO.

Lialin said that smaller hospitals might be drawn to the older desktop software while comprehensive cancer centers and reference labs would opt for the pipeline version, LymphoTrack.

In introducing LymphoTrack, Invivoscribe named Roswell Park Comprehensive Cancer Center in Buffalo, New York, as an early customer.

"Clinical labs need to be able to analyze large amounts of clonality and MRD data quickly and easily. Current bioinformatics software generally requires that technicians click through software to analyze data one patient at a time; this is both tedious and prone to human errors," Sean Glenn of Roswell Park's Center for Personalized Medicine, said in a statement provided by Invivoscribe. LymphoTrack is designed to address that problem.

While Lialin said that Memorial Sloan Kettering Cancer Center, the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, and the Stanford Cancer Institute have used Invivoscribe's bioinformatics to automate their pipelines, Roswell Park is the first to adopt the production version of LymphoTrack, which was built in Docker, a development platform for containerizing applications.

Lialin explained that the containerized approach allows end users to plug the software right into their pipelines and start running standardized analyses with minimal setup. "That's exactly what this software package is about at Roswell Park," he said. "I see this as a strategy to take a lot of the desktop tools that we have and to make them high-value, high-throughput informatics tools."

The Docker version of LymphoTrack is for research use only. Lialin said that Invivoscribe will not need regulatory review for the software, but end users that want to include the technology in a laboratory-developed diagnostic test will need to seek approval.

Invivoscribe has built up a large storehouse of data from samples sent in by clients over the years. The company historically has focused on hematological malignancies, though Lialin said that Invivoscribe is diversifying into solid tumors as well. He added that there are some "early projects" in the works outside of cancer entirely, specifically mentioning celiac disease.

"There are a broad number of areas and platforms that we can go after, and we're going to leverage our internal ability to procure samples as well as route and analyze those to have best-in-class software for our customers and our partners," Lialin said.

Lialin said that Invivoscribe will try to integrate bioinformatics with other lab services like the 12-color multiparametric flow cytometry the firm introduced in June.

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