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Seeing Opportunity in Digital Diagnostics, Roche Agreements Seek to Expand IVD Business Model

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NEW YORK (360Dx) – In a time of tightening laboratory budgets and staff shortages, digital diagnostics is generating much-needed value for clinical laboratories, health systems, and patients, and it is providing a springboard for Roche Diagnostics to grow beyond its core competencies, CEO Roland Diggelmann said.

The company has recently been on a buying binge, and its goal is to build up a cache of digital tools some of which could eventually consist of advanced analytics algorithms and provide decisions to clinicians within a regulated framework, Diggelmann said on the sidelines of the 70th American Association for Clinical Chemistry Scientific Meeting & Clinical Lab Expo in Chicago last week.

The firm's digital strategy, he said, is expected to have a positive impact throughout its ecosystem — on its laboratory customers; stakeholders in research and clinical settings; and on the way it engages with regulators and payors.

The firm is moving beyond providing in vitro diagnostics solutions that lead to results and data so that physicians can make the appropriate decisions to best treat patients, Diggelmann said. "We now are looking at opportunities to provide this data in a better fashion, and in a way that is more comprehensive, efficient, and effective — expanding our business model to provide workflows, technical decision support, and more solutions that enhance what we currently do."

To that end the firm has inked several acquisition agreements and engaged in an important strategic partnership. All support the firm's digital strategy.

The long-term partnership that the firm inked with GE Healthcare in January, for example, takes aim at jointly developing and comarketing digital clinical decision support solutions. The partners anticipate applying advanced analytics to in vivo data from GE's medical imaging and monitoring equipment and to in vitro data from Roche's biomarker, tissue pathology, genomics, and sequencing portfolio, leading to advanced software, clinical decision support, and workflow solutions.

The partnership will focus first on developing products that accelerate and improve individualized treatment options for cancer and critical care patients, such as those presenting with sepsis. Taking a narrow focus on two complex medical conditions is deliberate, Diggelmann said. It will allow a deep analysis of how the capabilities of the partnership can be brought to bear on analyzing these conditions, and the firms expect to then apply practices that they develop to other conditions including, potentially, infectious diseases other than sepsis and cardiovascular conditions.

To achieve this, two healthcare industry behemoths are coming together with complementary strengths.

GE Healthcare has "an enormous presence in healthcare markets and a deep understanding of the imaging workflow and how patients travel through a hospital," Diggelmann said. "We tend to look at the patient in the context of the clinical lab, and we know a lot about that. But when you look at the patient journey, many other modalities play a role, and GE is that element that will help us to aggregate imaging data."

In another move that takes it beyond in vitro diagnostics, Roche last year launched Navify, a clinical workflow and decision support software that optimizes decision-making for cancer patient case reviews in the clinic, on tumor boards, or in multidisciplinary team meetings.

The primary call points for placing Navify are outside the laboratory, Jack Phillips, president and CEO of Roche Diagnostics North America, said in a presentation at AACC. "We are heavily focused in oncology today, so we are speaking to nurse navigators, oncologists, the C-suite, radiologists, and all individuals who manage tumor boards in health systems."

Prior to the launch of Navify, getting the correct information together in one place was a manual, time-consuming process, Phillips said.

Navify Tumor Board, the first manifestation of the software, serves as a hub for performing clinical decision support based on electronic health records, laboratory, pathology, imaging information systems, genomics, and administrative datasets.

Among its features, Navify provides instant access for a treating physician to medical guidelines and insights into the availability of clinical trials that are a potential fit for a patient seeking a medicine.

Phillips said that in future versions, Navify will move to algorithms and other types of tools that will help clinical decision support.

Diggelmann also noted that the firm anticipates enhancing its existing Navify by providing access to patient information from the electronic medical record and imaging data from GE and possibly other modalities "to give the most comprehensive view of a patient because we realize that it's not just IVD information that you need to make a decision."

Providing clinical workflow and decision support software is one way that Roche Diagnostics is adding to what it provides as part of its in vitro diagnostics portfolio for the laboratory. Selling business analytics for the lab is another. In November last year, the firm acquired Viewics, a privately held business analytics company that it anticipates will enable labs to make faster, data-driven, and more informed decisions on their operations and processes. The cloud-based software is instrument-agnostic and accessible from multiple devices, including smart phones, tablets, and desktop computers, Roche said.

"Viewics looks at the business analytics of the lab — how a lab operates; which tests are being ordered, by whom and where; and the business economics behind the tests," Diggelmann said. He noted that such tools help labs to operate more efficiently and order the right tests when they are under cost pressures.

While Roche Diagnostics' recent acquisition focus has been centered in digital diagnostics, some were initiated by its pharma division.

In one such deal in April, Roche closed the acquisition of Flatiron Health, a provider of electronic health record software with a focus on oncology, for $1.9 billion.

Flatiron curates and develops real-world evidence for cancer research through its network of community oncology practices and academic medical centers across the US. It has collaborations with more than 265 community cancer clinics, six major academic research centers, and 14 therapeutic oncology companies. Its technology platform enables cancer researchers and care providers to learn from the experience of every patient, Roche said.

The deal was initiated by the Roche pharma division, which saw Flatiron as a means to provide structure to oncology patient data and create a highly curated format, Diggelmann said. Pharma needs the data for drug discovery and has used it to provide real-world patient information to the US Food and Drug Administration to help accelerate pharma-related regulatory approvals, he noted.

In 2014, Flatiron, then a standalone firm, struck a deal with Foundation Medicine to create an integrated data platform and develop oncology treatments. Last week, Roche Diagnostics said it was poised to close the acquisition of Foundation Medicine for $2.4 billion.

In June, Roche inked a definitive merger agreement with Foundation that it said will accelerate broad availability of comprehensive genomic profiling in oncology. Foundation's molecular diagnostic tests identify alterations in a patient’s cancer, and clinicians use the results to match patients with targeted treatments and clinical trials. The firm matches each patient’s unique profile to known targeted therapies, immunotherapies, and clinical trials, and it offers decision support tools.

Similar to the deal with Flatiron, Roche's decision to acquire Foundation was initiated by its pharma division, Diggelmann said. He noted that Foundation's products fit well with its digital data strategy because the firm can obtain "deep molecular insights at scale that can go far beyond what is being generated in terms of patient data today."

Foundation's next-generation sequencing-based method provides deep information about the patient's molecular status that leads to options and opportunities for treatments, he said. Importantly, Foundation also aggregates patient data that enables it to identify patient trends, provide critical information to pharma R&D teams, and provide better clinical data on patients that are outside the clinical trials setting, he said.

Physicians currently send patient samples to the Foundation Medicine laboratory and receive online and printed results within about two weeks. Roche will look to decentralize the Foundation model using joint assay development capabilities, Diggelmann said. Foundation Medicine's business has been primarily in the US, but Roche will support geographic expansion, and the firm's broad presence in diagnostics will support promoting and selling Foundation's deep molecular insights, Diggelmann noted.

He added that only 4 percent of all patients are in clinical trials, which are hypothesis driven and tightly managed in terms of patient selection. The clinical trial patient population is far more homogenic than is present in clinical settings outside trials, he said. Having this access to data on patients that are not in trials is potentially very valuable, he said, "and why there is interest in decentralizing the Foundation approach."

Although Roche sees significant value in digital diagnostics opportunities, Diggelmann said that it is important that it continue demonstrating strong results in its core businesses. By remaining on a successful path, Roche Diagnostics will ensure that it continues to generate the cash needed to invest in future opportunities, including those in the digital space. Its core in vitro diagnostics products currently account for about 95.5 percent of business, but the firm's commitment to expanding its digital presence is reflected by the focus of its presentations at the AACC meeting, he said.

Last year, the FDA launched its Pre-Cert pilot program as part of its Digital Health Innovation Action Plan to help push along digital health innovation and selected Roche as one of nine companies it is working with to create a pathway for precertification. The other firms include Samsung, Apple, Verily, Johnson & Johnson, Fitbit, Pear Therapeutics, Phosphorus, and Tidepool to work with it in creating a pathway for precertification.

The FDA’s pre-certification pilot program is intended to inform a tailored approach toward digital health technology by looking at the software developer or digital health technology developer, rather than primarily at the product, the FDA said in a statement. The goal of the new approach is for the FDA to precertify the company and, after reviewing systems for software design, validation, and maintenance, determine whether the company meets quality standards.

Diggelmann said that there are many opportunities in digital health to create a basic platform and then build on top of it to eventually develop solutions that need to be FDA regulated. For example, the Navify solution doesn't have to be regulated because the physician is making the decision, but "once you move to the point of making a clinical decision, then most likely you are moving into a regulated environment," he said. "Of course, if we provide algorithms and related solutions, we will have the burden of proof, and we will have to run clinical studies to prove that what we do and what we recommend is actionable."

Having a precertification tag could make any future registration in this domain easier for Roche, he said. "This is ongoing, and we will see what happens."