Diaceutics Developing New Platform to Improve Access to Precision Medicine

NEW YORK – Inefficiencies in the testing ecosystem that hinder patients' access to precision medicine drugs have been an ongoing problem.

Diagnostics data analytics company Diaceutics aims to obviate that with the launch of a new data marketplace later this year intended to streamline the process for matching pharmaceutical companies, diagnostic firms, and laboratories that are interested in working together to advance precision drugs, as well as companion tests that identify the patients who will or will not benefit from them. 

The Parsippany, New Jersey-based firm is in the process of rolling out its DXRX – The Diagnostic Network platform, which will create a space for precision medicine stakeholders to collaborate on the development and commercialization of drugs and companion diagnostics. The result of a $28 million investment in software and data, the platform will act as a "concierge service" to match opportunities posted by pharma and diagnostic firms, according to Diaceutics Head of Innovation Derek Hosty.

The stakeholders Diaceutics wants to attract to the platform include pharmaceutical companies providing personalized therapies, companion diagnostic tests developers, and laboratories developing and performing the tests. 

The codevelopment of precision drugs and diagnostics is complicated, and guidance from the US Food and Drug Administration doesn't always match the real-world application. According to FDA guidance, ideally drugs and diagnostic tests should be developed alongside each other, with the diagnostic test being used in pivotal trials to identify patient populations that would be eligible for those treatments. However, the agency has also recognized that due to the long development times for most drugs and the technology advances that occur in those times, diagnostic tests created at the beginning of a drug's development may be obsolete by the time the drug is ready for approval. 

Historically, targeted therapies were expected to be approved with one companion diagnostic test. However, as researchers continue to elucidate the role of genomics in diseases like cancer, drugmakers are also developing more and more new drugs to target disease-causing genomic alterations. As such, for certain diseases, such as non-small cell lung cancer, patients have multiple precision medicine options and need to be tested for multiple genomic markers to determine which therapy is best for them.

If every one of these drugs has its own companion diagnostic, that would require too many tests to be performed on the patient, making it unfeasible from a cost and tumor tissue access standpoint. Kenneth Bloom, chief medical officer of Konica Minolta Precision Medicine and a scientific advisor to Diaceutics, noted via email that this model isn't viable, partially because "as biopsies become smaller and smaller, there is often an inadequate amount of tissue to perform companion diagnostic tests serially. This is most evident today in the treatment of non-small cell lung cancer where possible target therapies include drugs targeting EGFR, ALK, RET, and BRAF mutations, as well as several checkpoint inhibitors, all of which are approved with a different but similar companion diagnostic."

With the availability of next-generation sequencing panels that gauge many genes at once, one test is able to check for multiple biomarkers, rendering the one-drug, one-test model outdated.

Diaceutics has been consulting industry players on the codevelopment of diagnostics and drugs and has been collecting and storing data from more than 2,500 labs globally over the past 10 years. The data they've collected includes information on lab equipment, capacity, accreditations, and approvals.

Its DXRX platform, intended for launch in the fourth quarter of 2020, harnesses that data to facilitate precision medicine partnerships. The aim is to open up communication between stakeholders so they can collaborate on commercialization of precision medicine drugs and companion diagnostics, Hosty said.

Previous analysis from Diaceutics has found that incorrect, inconclusive, and delayed biomarker test results have impacted thousands of patients per year and stopped them from receiving personalized and targeted treatments. 

Part of the problem, Hosty said, is that different countries have different regulatory requirements, so a companion diagnostic test that is approved by the US Food and Drug Administration is "only a part of the testing infrastructure that a pharmaceutical company needs to roll out globally."

When laboratories in other markets must implement a new biomarker test for a specific drug, "they have multiple options to consider, including laboratory-developed tests," Hosty added. "LDTs are a reality in many markets, either because of financial reasons or preferences in the lab community." In situations like these, "we need to consider how we support the labs to provide standardized testing, regardless of the testing option they choose," Hosty said. 

Bloom added high costs and supply chain issues lead to many labs trying to make their own versions of these tests. "Since most of the components of the kit can be purchased by labs at a fraction of the companion diagnostic price and existing instrumentation can be substituted, it is not a surprise that many labs attempt to create their own diagnostic," Bloom said.

The use of LDTs in the companion diagnostics space is common but it brings with it some historically thorny issues. The FDA doesn't regulate LDTs, which can lead to concerns and debates about quality. While running LDTs within hospitals' own labs can be cheaper, some might argue that if these tests weren't used to identify patients in the trial that led to the drug's approval, it's unclear whether the test is identifying the population most likely to benefit from the therapy. This uncertainty may mean that patients who shouldn't get the drug are getting it, or that patients are not getting therapy when they could benefit from it. 

In this complex environment, Diaceutics is introducing the DXRX platform hoping to offer a better way for drugmakers, diagnostics shops, and labs to identify codevelopment opportunities. Once the marketplace is available, pharma companies will have access to an end-to-end solution for the development and commercialization of precision medicine diagnostics, and laboratories and diagnostic firms will be able to find precision medicine projects that they can contribute their testing know-how to, Hosty said.  

Diaceutics started seriously developing the data it had acquired three to four years ago, and in January of last year it began to develop the front-end of the platform and the tools it intends to put in front of clients, Hosty said.

Currently, Diaceutics is in the process of creating and strengthening platform profiles for stakeholders based on the data it has amassed. The profiles will allow the stakeholders to identify potential partners for collaboration. Among the data the company has are patient and lab-level data, some of which is provided directly through agreements with labs in 51 countries.

Hosty said the company also has access to Medicare reimbursement information and data provided by commercial companies, as well as health record data from the state. It will continue onboarding laboratories and diagnostic firms on to the platform throughout the third quarter of 2020 and providing access to pharma clients in Q4.

Hosty added Diaceutics is giving some labs access to the data it has, allowing them to check it and fill in any gaps to improve the quality of the data. Profiles include information about the types of equipment a lab has, testing capabilities, experience, approvals, and accreditations.

An advantage for labs using DXRX is the ability to connect with other labs that have different resources, said Markus Eckstein, a surgical and molecular pathologist at University Hospital Erlangen's FAU Medical School in Germany and a scientific advisor to Diaceutics. There's an opportunity "to find other labs where you could send samples for testing for specific genetic alterations or other biomarkers if you don’t have these tests set up in your own lab," he said via email.

In the DXRX marketplace, stakeholders will be able to post diagnostic opportunities. For example, a pharmaceutical company may announce that it is looking for a development partner for a precision medicine drug or that it is recruiting labs into a network for a new precision medicine diagnostic. Diaceutics will use a combination of machine learning and analysis of profile data by its internal team to match the opportunity with the most appropriate partners, Hosty said. The data has been curated from Diaceutics' internal team, which has relationships with local labs, but the machine learning algorithm more systematically make matches based on the profiles, he added.

Pharma and diagnostic companies would also have "the opportunity to get insights [into] how testing is done locally and which methods or machines are used or available," Eckstein said.

One of Diaceutics' goals with the marketplace is to accelerate the adoption of new or existing biomarker tests, facilitating pharma companies a shorter time to market and increasing patient access to tests, Hosty said.

A pharmaceutical company using the network would be able to coordinate each aspect of a new biomarker launch, from biomarker discovery to market availability of a test, Hosty said. "They would be able to monitor and drive test adoption by directly engaging with the laboratory network providing that test and with industry partners providing implementation services, such as pathology training, proficiency, and reference materials, the stakeholder physicians, and their testing behavior."

Once the pharmaceutical company has been given access to a network of partnership opportunities, specific contracting occurs directly between the parties and can be facilitated by Diaceutics as needed. Initial interaction on the platform wouldn't require sharing proprietary information, Hosty noted, but as the partnership moves further along, "there is a provision for secure sharing of confidential and proprietary data among selected partners."

Hosty noted that Diaceutics isn't simply handing the raw data over to partners, but instead uses its team of experts "to interpret that data and inform the strategy for the rollout." Hosty noted that the company is also providing coaching, training, and reference materials to labs to help them improve companion diagnostic testing capabilities. These resources are a major benefit of the marketplace, Bloom said.

"Many of the laboratories that perform companion diagnostic tests are doing so as a service to their patients but at a loss because of the expenses they incur in purchasing the necessary equipment, hiring and training the necessary staff, and the cost of the companion diagnostic reagents," Bloom noted. "With access to appropriate reference material and help in guiding them through the validation process, they will be able to create an equivalent test within their existing infrastructure."

The only potential downside, Bloom added, is "the expense and time of attempting to create an equivalent test and failing." However, many labs are already in that position today, lacking guidance and validation materials and creating suboptimal tests. 

Every market is different and has different needs, which Hosty said Diaceutics recognizes from the outset by building infrastructure for different diagnostics. No one should expect to get a test "on market and get it to all eligible patients with a single CDx option," Hosty said. "You have to recognize the individual needs in each market." Those differences could entail different strategies to achieve reimbursement for tests, for example.

Diaceutics has consulted on numerous precision medicines brought to market in the past decade, and that work "has revealed a testing ecosystem which is broken," Hosty said. "The number of precision medicines coming through the pipeline is growing at a pace that we feel a platform with a diagnostic network is the best way to ensure that we can fulfill the growing needs."