CHICAGO – After seven years in business and one reinvention, Standard Molecular finally hit the commercial market last month by introducing ConnectOTR, a technology platform aimed at simplifying molecular test ordering for community oncologists. The startup hopes that its product will streamline the process of selecting appropriate assays, ordering tests, receiving results, and interpreting those results to diagnose and treat cancer.
CEO Jeffrey Sopko said that the Cambridge, Massachusetts-based company wants to make next-generation sequencing a standard of care across all branches of oncology, even in community settings.
"The inconsistency of these tests across disease states is terrible," he said. "Ultimately, we think that's something that needs to get solved."
It takes too much time to choose a laboratory, get the test started, and receive results, according to Sopko. When a report does come back, it typically contains dozens of pages "of a lot of nonsense that a treating doc doesn't really need," he said. At the same time, the test report does not easily integrate into electronic health records.
"It's way too complicated," Sopko said.
Standard Molecular wants to address this problem with ConnectOTR. (The three letters at the end stand for "order to results.") The cloud-based system contains several modules, called InterAct, Uniformer, IntelliMatch, and Results Analysis, to allow a physician to use a single platform from test selection through results delivery and interpretation.
InterAct is intended to be embedded into EHRs as an order interface. "Think of it as a very simple way for an oncologist to pick a test and get the requisition completed," Sopko explained.
The second piece, Uniformer, is a proprietary application for standardizing genomic data in a single format to, as Sopko put it, "make inconsistent genomic data useful for providers and life sciences companies."
IntelliMatch is a knowledgebase and content management module that makes clinical information machine-readable to inform clinical decision support processes by matching test results to a library of biomarkers and variants.
"It is a very powerful content management tool that matches facts of nature with facts of science. When those two things come together, hopefully, there's an action statement for an oncologist to take on your behalf as a patient," Sopko said.
The final piece, Results Analysis, cross-references genomic data with clinical content to suggest treatment alternatives. This is an ongoing process that physicians can consult regularly as clinical knowledge and drug approvals advance.
Standard Molecular has applied for a US patent on the ConnectOTR platform and each module, according to Sopko.
Sopko said that the company is not involved in creating clinical content or in providing direct clinical decision support.
"However, IntelliMatch allows a customer to use the clinical content of their choice," such as National Comprehensive Cancer Network guidelines, Sopko said. IntelliMatch compares individual test results to the chosen databases, then provides findings to the physician.
"It enables an action to happen faster … more accurately, and … to happen based on the most recent clinical data," Sopko said. "But we are not writing clinical action statements."
Standard Molecular's target end user is the community oncologist, though the company hopes to market to physicians through EHR vendors that serve oncology practices. Sopko also wants to market to pharmaceutical and life sciences companies that are involved in therapeutic discovery in oncology.
Sopko noted that Uniformer can segment findings into those that are clinically actionable today and those that are not yet actionable. "That body of information can be very, very useful to someone in the discovery business looking for the next therapy," he said.
For now, Standard Molecular's business model is still mostly about getting its product into cancer clinics. "But we absolutely know the … therapeutic discovery marketplace is an area where we think the data that we'll be gathering will become quite valuable," Sopko said.
Standard Molecular has not announced any customers and still considers itself "prerevenue," according to Sopko.
It has been a long journey just to get to this point.
Chesley Leslin, a Northeastern University bioinformaticist, and David Artz, then-medical director of information systems at Memorial Sloan Kettering Cancer Center, founded Standard Molecular in 2014.
According to Sopko, Artz, a practicing internist, was "frustrated" with some of the challenges of incorporating NGS into medical practice and cancer research alike. "It was just a [combination] of bad people processes, bad technical processes, and outdated technology," Sopko said.
Artz subsequently led the creation of Continuity GIS, a genomic information system to streamline molecular pathology at large hospital systems. Sopko joined the company as chief commercial officer in early 2018 to commercialize the product. He was elevated to president and CEO a year later.
However, around the same time Sopko came on board, the US Centers for Medicare and Medicaid Services issued a coverage determination on laboratory-developed tests that was unfavorable to Standard Molecular's long-term prospects of selling Continuity GIS.
In the wake of the CMS decision, Sopko, whose background was in physician-focused healthcare technology, decided that it was best for the business to turn its attention elsewhere.
"I made the argument to say, 'Why don't we start figuring out what's causing issues with oncology care for the community oncologists, because that's where most patients are being treated?'"
Sopko said that the firm started asking "fundamental questions" about NGS testing in oncology, and identified the chokepoints that ConnectOTR is addressing.
Standard Molecular is privately funded. Sopko did not disclose the names of backers, but Tracxn, a website that tracks investment in technology companies, indicated that the firm raised a seed round worth more than $1.4 million in 2018 with support from Canepa Healthcare and Evidity Health Capital.