NEW YORK – Outcomes4Me is optimistic that a newly inked deal with Labcorp and partnerships with pharmaceutical companies will help it improve cancer patients' access to biomarker testing and precision treatment.
The Boston-based company, founded in 2017, operates a free patient-facing mobile app, with which it hopes to empower patients with information about their cancer diagnoses and treatment decisions. At its most basic level, the app is a patient education tool: It consolidates data from electronic health records and, using artificial intelligence, delivers information relevant to each patient. The app carries a disclaimer that information patients receive through it does not constitute medical advice and cannot replace the role of the oncologist.
Still, Outcomes4Me created the app after recognizing that many oncologists find it difficult to keep up with rapidly changing biomarker testing and treatment guidelines for different cancer types.
"There are now over 20 subtypes of breast cancer in terms of how we treat them," Outcomes4Me Founder and CEO Maya Said explained. "Most people in the US are treated by general oncologists in community centers, not specialists, and every time there's a new innovation in oncology that's biomarker-driven … it's just impossible for them to keep up with the pace of innovation in cancer."
Indeed, the pace of advancements in precision oncology is increasingly cited as among the drivers of access disparities in the field. Oncologists may not recognize that a patient qualifies for biomarker testing, or they might not be able to identify the appropriate treatment for a patient based on biomarker test results when the link between a drug and biomarker is new or not well established.
This is the gap where Said sees Outcomes4Me's app making a difference. "We need to use technology to enable a much more rapid dissemination of knowledge," noted Said, who first recognized precision oncology's pace-of-innovation conundrum while leading global market access and policy efforts within Novartis' oncology business. "This is why we started a direct-to-patient platform giving them all the tools to enable them to take a proactive approach to their care and participate in shared decision-making."
The Outcomes4Me app integrates National Comprehensive Cancer Network (NCCN)'s treatment guidelines. Because navigating these guidelines can be complex for providers, let alone patients, Outcomes4Me has a dedicated team that translates these guidelines into patient-friendly, accessible language. Through a collaboration with the NCCN, the firm pays the organization to review these translated guidelines for accuracy and give Outcomes4Me the final approval to go live with updates on its patient-facing app.
"Something like that actually costs a lot," Said added, explaining that the NCCN collaboration works like a licensing deal, within which Outcomes4Me pays NCCN for the guidelines content, as well as the time and expertise it takes for the content review and sign-off.
Keeping it free for patients
Creating this app and keeping it patient-friendly, accurate, and up to date so that it provides information that patients might not be able to access through their providers is not an inexpensive feat. But because the company's foundational goal is to increase access to biomarker-defined cancer treatments, Said emphasized that charging patients to use the app is not an option. "The minute we charge for it, we're limiting access," she said. Instead, the firm makes money from patient education programs sponsored by commercial labs and with pharmaceutical companies.
"We found this business model aligns with our number one priority, which is patient-first and patient-aligned," she said.
The new deal with Labcorp, announced last week, is a direct example of Outcomes4Me's business model. Labcorp made a "significant" equity investment, according to Said, who didn't disclose the amount. Outcomes4Me, meanwhile, is providing patients who use the app with information that raises awareness about biomarker testing. The app makes clear to patients that Outcomes4Me is providing this information — in this case, the information deals with how knowing one's HER2-low status can benefit breast cancer patients — under a program sponsored by Labcorp.
The need to identify patients who have low HER2 expression in their breast tumors became necessary with the approval of Daiichi Sankyo and AstraZeneca's Enhertu (trastuzumab deruxtecan) for patients who have HER2 immunohistochemistry scores of 1+ or are IHC 2+ without gene amplification by in situ hybridization.
Although Labcorp sells a suite of oncology diagnostics, including HER2 testing, Said emphasized that the sponsored education materials give patients information about the potential value of certain biomarker tests but don't recommend or promote the sponsor's own test over others available on the market.
"Labcorp … doesn't get any control or any preferential treatment," she said. "We work with every company and with direct competitors of Labcorp [to] provide comprehensive, personalized, evidence-based information irrespective of any sponsorship agreement."
Of course, educating patients about a certain biomarker like HER2-low and providing them with prompts and questions to discuss that biomarker's testing option with the provider could drive business to commercial labs. But Said emphasized that, as a patient-first company, Outcomes4Me does not promote Labcorp's tests over those of its competitors just because of an equity investment. All laboratory tests mentioned in the NCCN guidelines are equally presented on the app, Said added.
"The information provided [to the patient] is to start the conversation with the provider," she said. "Labcorp is one of the tests available, but it is not the only one, and the provider may have alternatives."
At the end of the day, the patient's oncologist — and, indeed, their insurance provider — still end up making decisions about which test a patient gets. "All that we are doing is helping patients have access to the same evidence-based information in a patient-friendly way so that they can participate in shared decision-making."
Even though the information in Outcomes4Me's app shows no favoritism to the products offered by the companies it partners with, Said characterized the latest deal as a win-win-win, for her firm, patients, and also Labcorp. Outcomes4Me is collecting data that could be useful for the reference lab, such as how aware patients are of their HER2-low status and whether they're getting tested. Labcorp is also promoting the Outcomes4Me app via television advertisements that run at their testing locations.
Patients can opt in to have their testing results from Labcorp sent directly to their Outcomes4Me app. Even though the test still needs to be ordered by a patient's treating oncologist, who gets the test report, the app ensures patients don't have to wait for a call from their doctors to learn about their results. Though Said acknowledged it can sometimes be problematic for a patient to see their test results without physician involvement, especially when the results are complex, she said this is already happening anyway.
Under the provisions preventing information blocking in the 21st Century Cures Act, healthcare providers have to release test results in patient portals. This means that often patients see test results before doctors can call them, which can result in confusion and potential distress, but at the same time, patients also prize having access to their own medical data as soon as it's available.
"It's only going to get more complex because there's less and less resources on the provider side," she said. "Plus, patients and consumers are becoming more proactive in general. That's why we feel our platform is very important because it helps patients understand the information and make sense out of it."
Outcomes4Me tries to get ahead of scenarios where patients might feel anxious about or misunderstand the information they see through the app by giving them the option to speak with nurses, who can help them make sense of their test results and direct them to the right information. Said reiterated that the app doesn't provide medical advice; rather, the nurses might suggest questions for a patient to ask their doctors.
In 2021, Outcomes4Me inked another partnership with a commercial lab, Invitae, through which Outcomes4Me began giving patients the option through its app to make appointments with Invitae's Genome Medical genetic counselors.
Diagnostics companies aren't Outcomes4Me's only partners. The firm is working to finalize deals with drugmakers, too, focused on clinical trial recruitment, Said explained.
Already, the app integrates with ClinicalTrials.gov and uses algorithms to identify trials that patients can potentially match to based on their cancer type, location, biomarker testing results, and other individual information. Said clarified that Outcomes4Me would not promote a given clinical trial for a partnered drugmaker's treatment above another appropriate trial just because they have a deal with the company. "Our North Star is to never compromise the patient experience, so the patient is able to see their best matches irrespective of [partnerships]," she said.
Still, there are benefits to pharma companies that partner with Outcomes4Me. "When pharma pays us to help them accelerate the recruitment around the trials, what we end up doing is proactively reaching out to the patient and saying, 'Hey, you may be a match for this trial. Are you interested in learning more? If you are, here's more patient education material that we've gotten beyond what's on ClinicalTrials.gov.'"
While Outcoems4Me hasn't publicly disclosed any pharma partnerships, it is planning to announce several deals soon, according to Said.
Looking ahead, in addition to garnering more of these partnerships with life sciences companies, Outcomes4Me, which launched focusing on educating breast cancer patients, has ambitions to expand into other cancer types. Starting with apps for breast cancer patients was a deliberate choice, however.
"If you really want to enable precision oncology, you have to go extremely deep into the indication. When we launched the company, we wanted to spend a lot of time on one indication," Said observed. Last year, Outcomes4Me launched offerings for lung cancer patients, and next year it will announce programs for patients with other types of cancer.
As it expands its platform and seeks out new partnerships that will allow it to continue providing its resources to patients for free, Outcomes4Me is also working to raise patient awareness of its app. On that front, the company recently inked another deal with Forecast Labs, part of Comcast NBCUniversal, to promote its app through television ads.
"To really unleash the power of precision oncology, we have to help empower patients with the right information to take a proactive approach to their care," Said said. "Our partners share our vision."