Skip to main content
Premium Trial:

Request an Annual Quote

Startup Spesana Developing MDx Clinical Decision Support Software

Premium

CHICAGO – Former Inteliquet CEO Carla Balch has quietly launched a new venture, Spesana, which is developing a visualization-based clinical decision support tool to help medical practitioners make sense of molecular diagnostics tests and the massive amounts of data that accompany the test results. 

Balch had left Inteliquet, a maker of clinical trial matching software, after serving as CEO for a little more than a year, leading that company through a rebranding from its former name, TransMed Systems.  

 

According to Balch, it remains difficult to put together various types of information, for example about clinical trials and drugs, to help physicians take care of their patients. "We're not able to put [that] together in a meaningful, elegant way to make it work. That's really what I'm after," she said.

A better infrastructure is needed, she said, because data from electronic health records today is "completely holey." As physicians and their staff try to aggregate data across health systems and vendors from practice management systems, laboratory information systems, and all kinds of types of notes in the EHR, including patient-reported outcomes, they find many missing pieces. 

"There is a lot of information that needs to be both ingested and then contextualized or improved," Balch said. "Being able to move that data from place to place is really important."

Spesana is looking to ingest molecular diagnostic reports into electronic medical records and provide context for them, as many others, including Epic Systems, Allscripts Healthcare Solutions subsidiary 2bPrecise, and startups such as Ciitizen do. "But that generally is a document in the EMR," often a PDF, sometimes derived from a fax, Balch said. Each test is a document, a single piece of information used to make a diagnosis or create a treatment plan. But doctors often need to go back to earlier tests and reports and consider comorbidities. 

"[For] each patient, the physicians are trying to create a precision medicine plan for within the context of payor guidelines and pathways, but that's just difficult," she said. 

Spesana, which is self-funded and currently has fewer than 20 employees, is trying to fill in those gaps with patented visualization technology that Balch coinvented. While the patent officially belongs to Nant Holdings, a Spesana spokesperson said that Balch has an agreement with Nant that allows her to use the invention freely. 

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

One reason that molecular diagnostics has been underutilized so far is that "the reports just are not helpful," she said. 

Her 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, according to Balch. 

The patent itself, US Patent No. 10,460,446, titled "Image-based circular plot recognition and interpretation" and granted last October, 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 memory may store software instructions that encode a machine executable circular plot analysis agent," the filing says, which "includes multiple functionalities that focus on initiating one or more transactions based on digitally observing a circular plot, a whole genome sequence plot of a tumor for example."

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. This, according to the summary, allows an automated "agent" to initiate an action such as a query to a database. 

This multi-functionality merits a patent, according to Balch, because so many health systems "are so desperate to find a new solution for their current problems, they end up buying a point-to-point solution, and that's not really moving the ball forward."

Point-to-point, which means technology that addresses a single pain point, such as prior authorizations for MDx testing, is not sufficient, she said. "That is putting a Band-Aid, if you will, on one of the very painful workflows that happens in the back office." 

Spesana is trying to manage the workflow. Balch mentioned one physician she talked to this month who got referrals in by fax, and the documents showed up sideways. It was impossible to run optical character recognition on those referrals to convert the flat documents to computable text with the practice management software that doctor had. 

"Until we really look at all of the links in the circuit that need to be opened and information flowing, we are not going to be able to close this circuit," Balch said.

The Spesana founder calls herself a visual problem solver. "I end up usually trying to tell a story with a picture," she said.

Clinical decision support for MDx incorporates molecular tests, diagnostic processes, approved drugs, and clinical trials. "All of those things are implicated and again [it] goes back to a lack of infrastructure that helps clinicians and pharma and payors," Balch said. 

She is perhaps best known for heading Altos Solutions, maker of an oncology-specific electronic medical record system called OncoEMR. Flatiron Health acquired that company in 2014, and Balch continued to run Altos until leaving for NantCare in 2015. She joined TransMed, which later became Inteliquet, in 2017. 

OncoEMR was the first oncology-specific EMR to get certified by the Department of Health and Human Services' Office of the National Coordinator for Health Information Technology to help providers earn Medicare bonus payments under the "meaningful use" incentive program.  

 

In starting Spesana, Balch turned to Latin for the company's name, which more or less means "hope for health," she said. Inteliquet also derives from Latin. "Liquet" means "it is clear," so the Inteliquet name represents intelligence from clarity. 

Spesana merges the MDx and science that Balch was responsible for at Altos and TransMed/Inteliquet. 

"[It] really was an epiphany of sorts for me in that there's so much science that certainly the general populace doesn't know about, but even really talented clinicians don't have time or access to all of the deep science that's happening," Balch said.

Since the company is still in stealth mode, Balch did not go into detail about the technology and how it would fit clinician workflows. She hopes the official rollout will happen in late spring.

Balch said she decided to talk about Spesana publicly after attending the JP Morgan Healthcare Conference last month and not finding innovation for making MDx more available to physicians and better fit their workflow. 

"If we don't set up an infrastructure and a workflow, [MDx information] will be a tsunami that hits the clinician," Balch explained.

There is plenty of science about available therapeutic options for cancer patients, for example, "but there is no way to help it become a reality for patients," Balch said. 

In the months since leaving Inteliquet, Balch has been interviewing physicians about their reasons for not ordering MDx tests. Often, it is the lack of reimbursement, an issue long raised by testing firms, including NantHealth

 

"They don't know if the test is going to be paid for. They don't know if the drug that will be recommended is any different [from the one] they may have pulled out of their bag anyway," Balch said. "But more importantly, they don't have the confidence."

She said that fewer than half of the physicians she spoke to were confident that data in MDx reports was clinically actionable. 

"If we can make the molecular tests and the reports more meaningful, then more patients will get molecular tests. If more tests are ordered and treatment is prescribed according to that, we are going to have better clinical outcomes or more patients on clinical trials," Balch said. 

Spesana will be starting in oncology, an area Balch said she understands well. 

However, she does have plans to expand into other medical specialties and therapeutic areas, likely Alzheimer's disease and rare genetic diseases. 

Balch also wants to collaborate with EMR vendors to fit clinical decision support into physician workflows at the point of care. 

"Working with the EMR is something that we will do. But it also raises the question, is the EMR — and I say this from experience —the right place to do incredibly complex, deeply scientific calculation and decision support, or shall we consider a different layer of intelligence that collaborates with the EMR?"

EMRs often rely on third-party plug-ins for clinical decision support, and Spesana wants to fill that role in the realm of molecular diagnostics.

Balch also is big on partnerships because they help close gaps. She said that Spesana has had "discussions" with multiple constituencies in oncology. She did not disclose their identities, but said that this group includes a health system with a Phase I unit for oncology trials, a large national insurance company, a manufacturer of molecular tests, and a life sciences company with a targeted oncology pipeline.

While Spesana is self-funded at the moment, it is looking for investors. Balch is being deliberate with that step. "We want to take in money from the right partner," she said. "The right partner is someone who is deeply innovative, who can understand not only the science but also the challenges of oncology and Alzheimer's and rare disease molecular diagnostics."

Balch is based in Memphis, Tennessee, but she is planning on making Spesana a virtual company, as Altos largely was. "We will hire talent where we find it and save money by not having a huge office," she said.  

 

The Scan

Fertility Fraud Found

Consumer genetic testing has uncovered cases of fertility fraud that are leading to lawsuits, according to USA Today.

Ties Between Vigorous Exercise, ALS in Genetically At-Risk People

Regular strenuous exercise could contribute to motor neuron disease development among those already at genetic risk, Sky News reports.

Test Warning

The Guardian writes that the US regulators have warned against using a rapid COVID-19 test that is a key part of mass testing in the UK.

Science Papers Examine Feedback Mechanism Affecting Xist, Continuous Health Monitoring for Precision Medicine

In Science this week: analysis of cis confinement of the X-inactive specific transcript, and more.