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Spesana Clinical Decision Support Platform Debuts With Proteomics Focus Through mProbe Alliance

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CHICAGO – This month, clinical decision support startup Spesana officially exited stealth mode, introduced its software platform, and started beta trials at five US sites in hopes of making molecular and other diagnostics a more integral part of cancer and pulmonology care.

Spesana has developed a visualization-based clinical decision support platform to help medical practitioners make sense of molecular diagnostic tests and the massive amounts of data that accompany the test results. 

This technology helps clinicians and payors understand and act upon diagnostic test reports. "This allows for advances in the super-stratification of patients on a molecular level, improved methodology for electronic prescriptions, as well as better decision support and workflow optimization," Spesana said in a statement.

Clinical decision support for MDx generally incorporates molecular tests, diagnostic processes, approved drugs, and clinical trials. The company said that its normalized data supports workflow and quality improvements in selection of therapies, prior authorization, patient copay assistance, and clinical trial enrollment.

According to Founder and CEO Carla Balch, the technology is a true platform, not a point-to-point connector that others might brand a platform.

"When you provide a platform, it's because you want to lock arms with like-minded companies. who want to do the right thing for cancer patients, and in this case, pulmonology patients, too," Balch said.

Balch is based in Memphis, Tennessee, but Spesana has been run as a virtual company even before COVID-19 forced so many office workers into their homes.

Spesana's platform adds context to and exports test reports to EMRs from multiple vendors. Allscripts Healthcare Solutions subsidiary 2bPrecise, and startups such as Ciitizen offer similar aggregation services, but Balch said that those companies sometimes package the reports as noncomputable PDF files, whereas each report from Spesana comes in as discrete data, making it more useful for analytics.

Spesana has named four of the five beta-testing sites for its platform: Prisma Health's Institute for Translational Oncology Research in Greenville, South Carolina; Duke LifePoint Healthcare's Haywood Regional Medical Center in Clyde, North Carolina; FirstHealth of the Carolinas; and the University of Pennsylvania Medical Center. The company has not received permission to announce the fifth location, but Balch described it as a large US institution.

Spesana uses patented visualization technology that Balch coinvented. While the patent officially belongs to Nant Holdings, Balch has an agreement with Nant that allows her to use the invention freely.

The patented technology provides a "visual that has lots of very complex, sophisticated layers of information in it," which could take three to four dozen pages of text to explain to an oncologist, Balch explained to GenomeWeb earlier this year. 

The patent itself, US Patent No. 10,460,446, titled "Image-based circular plot recognition and interpretation" and granted in October 2019, covers hardware, software, and methods for computers or smartphones to "initiate transactions based on a digitally observed circular plot" — a round graph of data points — according to the patent summary.

The technology detects perimeters of digital images produced by visualization tools and eventually identifies a set of endpoints distributed around the perimeter to generate plot descriptors in "circo" graphs. This, according to the summary, allows an automated "agent" to initiate an action such as a query to a database. 

Circos are central to the beta phase, during which Balch wants to demonstrate how Spesana can make MDx tests more clinically useful. During a video conference with GenomeWeb this month, she showed circos of mutations associated with a triple-negative breast cancer patient in a clinical trial.

The first one depicted a biopsy of one breast from day four after diagnosis and the second a biopsy taken on the same breast on day seven. The number of mutations and alterations had grown in just three days, indicating metastasis, but payor pathways call for the patient to stay on the original therapy unless a CAT scan reveals disease progression.

Balch said that the patient died on day 250 post-diagnosis.

"This makes me mad because we have this science and we have the technology to do better," she said. "This [MDx result] should have been at least a component part of the decision for the physician."

She said that healthcare is ripe for a new, technology-driven environment of collaboration between physicians and payors, and Spesana wants to support that by making it easier for practitioners to understand MDx reports.

Balch also talked on taming the "chaos" in the life of oncologists today by helping them find and act upon information that often is stuck in data silos and buried in EMRs.

Users can order any MDx test directly from the Spesana platform rather than having to go to each test provider's portal. Spesana auto-populates the lab forms from the patient data it ingested from EMR and previous test reports.

Balch explained that oncologists and pulmonologists often do not know which diagnostic panels to order because the tests are expensive, there are so many to choose from, and they are unsure which ones insurance plans will cover.

Results reports can be dozens of pages long and often get buried in EMRs, too.

"That's a workflow problem," Balch noted, one that Spesana is trying to solve by highlighting the specific form a physician is working with at any given time.

"As we aggregate information and show everything on one screen, that's the 'Aha!' moment" for users, Balch said. "It's all presented there: radiology, pathology, payor, diagnostics, physician notes from all systems related to that patient."

Doctors can get a full picture of a patient's status by looking at information across multiple settings of care. Spesana also can help physicians who are not all that familiar with proteomics or genomics see what kinds of tests others have ordered for similar patients.

"There's a challenge for getting physicians to understand genomics, but then beneath the genomics is proteomics," Balch said. "We will be moving the needle on understanding all of these, and it really will become the standard of care to have these types of sophisticated tests" to guide treatment decisions to indicate which treatment it is."

Quantitative proteomics testing services are coming from mProbe, an AI-driven "precision health" company based in Mountain View, California, one of four commercial partners for the beta phase, and the only one Spesana has revealed to date. That firm promises results in five business days from the time its lab receives a sample. Results feed back into the Spesana platform.

"This will cover not just the targeted markers, but also the chemotherapy biomarkers as well," said Sheeno Thyparambil, mProbe's Rockville, Maryland-based senior director of R&D.

MProbe, which historically has focused on mass spectrometry-based metabolomics analysis, actually is still testing its clinical proteomics product; Thyparambil said to expect a commercial launch soon. But the firm has run thousands of quantitative proteomics studies on patient samples in the last eight years, mostly for pharmaceutical companies, including Roche and AstraZeneca, two firms Balch said are working with Spesana on the beta test.

Thyparambil and Balch have a longstanding professional relationship, with the common thread being Patrick Soon-Shiong's NantWorks conglomerate.

Balch spent nearly two years as president of NantCare, the remote patient monitoring and medical device connectivity arm of NantWorks. At the same time, she was senior vice president for clinical strategy of sister company NantKwest, which focuses on immunotherapy development.

Thyparambil joined mProbe precursor Expression Pathology in 2009, which later became OncoPlex Diagnostics and was acquired by NantOmics in 2015. NantOmics sold the OncoPlex Diagnostics laboratory in Rockville, Maryland, to mProbe in 2019. That site was among the first CAP-accredited and CLIA-certified labs to offer quantitative proteomics services.

"Quantitative proteomics sometimes gets buried in all the reports that come out, so we want to bring it to the forefront, and this is where I think the collaboration between Spesana and mProbe is going to be fruitful for us and ultimately for the patients," Thyparambil added.

The mProbe technology, now called OncoOmics Dx, operates with a dashboard-style front page, displaying a "green" list of likely actionable targets and a "red" list of targets with resistance markers in them.

According to Balch, 85 percent of oncology drugs now in development are targeted therapies, which raises the importance of understanding each patient's molecular diagnostics.

"If there is a pharma with an oncolytic in development, they really need us to help move molecular diagnostics and other omics, including quantitative proteomics, forward," she said.

The Spesana CEO is keen to get going on the pharma side. "Pharma does not have all the information that they need for new drug development and for clinical trials, and they don't have all the connections," she said.

The startup is acting as a connector in the age of COVID-19, in which telemedicine and other forms of virtual care finally achieved mainstream acceptance. The platform enables real-time chat between healthcare professionals and medical affairs specialists at drug companies.

"This instant collaboration between provider and medical affairs in pharma is a request from physicians," Balch said.

Balch said that Spesana moves users beyond an EMR. "An EMR is not the place for this sophisticated decision support," she said. "We're letting physicians look at clinical context and molecular [data]."

The new company has applied for a second US patent for what Balch called "machine vision."

"We arrange everything for the physician from across all systems — radiology, pathology, and molecular diagnostics — and then let the physician put her eyes on that patient and say, 'I know exactly what I need to do,'" Balch explained.

To go from starting the company at the beginning of the year to beta tests in October "is a deep indicator that we have hit a nerve," Balch said. "Physicians are craving something that they do not have."

She said that Spesana will likely introduce a research-focused product next year.

Since February, Balch said that the company made some changes to its technology after hearing from physicians that they want to be able to collaborate on the platform.

"A pulmonologist gets a patient and needs to talk to either another pulmonologist or an oncologist. Our platform allows instant collaboration and oh, by the way, that collaborator has a billable event," Balch said. It also means that the patient does not get shuffled back and forth between the two specialists.

If the patient does need to be referred, Spesana can expedite the process by instantly creating and sending machine-readable referral records that the consultant can import directly into the EMR rather than dealing with faxes or PDFs.

Balch said that Spesana follows standards to allow integration with EMRs, laboratory information systems, and practice management systems. By next year, the company will add support for patient-reported outcomes and social determinants of health, which Balch said will help improve diversity in clinical trials.

"We are about providing information for all stakeholders so that they can do better," Balch said. "We're the antithesis of data hoarders. We are aggregators and then presenters to the right stakeholders."

She said that this collaborative nature can help ease historical tensions between physicians and payors. "They're now faced in the same direction for the benefit of the patient, which is a big deal."

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