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With New Partnerships, Diaceutics Works to Standardize CDx Testing Globally

NEW YORK –Diaceutics has been working for more than a decade to improve delivery of precision medicine diagnostics and facilitate understanding between pharmaceutical companies and diagnostic firms to better initiate companion diagnostic development.

As Diaceutics gears up to launch its new online DXRX platform in the fourth quarter of 2020, a data marketplace intended to facilitate collaboration between stakeholders in the diagnostic and pharmaceutical industries, it has inked partnerships with a variety of organizations that will be involved in the network. 

Last month, the firm announced agreements with Canadian Pathology Quality Assurance – Assurance Qualité Canadienne en Pathologie (CPQA-AQCP), European Molecular Genetics Quality Network (EQMN CIC), and Nordic Immunohistochemical Quality Control (NordicQC). The three external quality assessment organizations provide proficiency testing for laboratories performing diagnostic tests.

Diaceutics also recently announced partnerships with HistoCyte Laboratories, which provides control slide materials, and Targos Molecular Pathology, providing training for laboratories.

According to Karina Hjort, the senior director of innovation at Diaceutics and the person responsible for securing these agreements, the "entire ecosystem" of companion diagnostic testing is broken, with too little communication or collaboration, and these partnerships can help address the issue. "We also need to help pharma to understand that standardizing Dx testing is a very important part of getting a drug to the market and successfully treating patients, the right patients, for a specific drug, and that can only be done with quality assurance."

The Pharma Precision Medicine Readiness Report 2020 from Diaceutics, released this week, also emphasized the company's goal of accelerating development of precision medicine from years to months. Currently, it takes an average of 4.5 years to optimize testing for precision medicine, the report said. 

CPQA-AQCP and NordicQC are both focused specifically on immunohistochemistry testing, and CPQA-AQCP also has expertise in fluorescence in situ hybridization testing. EMQN CIC, meanwhile, provides molecular genetics and molecular pathology-specific assessments for global molecular testing. She noted there are more EQA partnerships in the works, although she declined to specify which agencies would be involved, adding that Diaceutics is open to partnering with experts in different types of testing, including next-generation sequencing.

Hjort noted that right now pharma companies, diagnostic firms, laboratories, and EQA bodies are working independently – which she said is a problem for ensuring everything is ready when a drug is launched. "Pharma partners need to invite [EQA organizations] to the table much earlier so that they can be ready with their EQA modules and proficiency testing when the drug is launched," rather than the usual timeline of more than a year after launch, she said. "We are facilitating that with this approach."

Early contact with pharma partners when new treatments based on companion diagnostics are being introduced is crucial for EQA programs as well to provide proficiency testing and support laboratories implementing tests as soon as possible, Søren Nielsen, the director of NordiQC, said via email.

Being able to access "all elements within the lifecycle of precision testing" is a major selling point for organizations involved with Diaceutics, Nielsen added. "Typically, enormous efforts and time have to be used to identify the right partners, complicating the process. With the DXRX platform we expect a more direct and effective roadmap, and each partner can use the time to focus on their specialty in the testing ecosystem."

Access to these training resources can be difficult for many labs, resulting in under-use, Hjort continued. But by making the training modules and quality testing more easily available and facilitating transparent communication across organizations, "it becomes a possibility for us to standardize the testing across different countries," she said. "Today there is no such communication platform which provides the transparency needed to track, maintain, and enhance testing quality standards."

EQA agencies can benefit as well, using the platform to "understand the needs from our direct partners," namely laboratories performing tests and pathologists performing read-outs, as well as pathology interest groups and regulatory bodies to "settle the expectations and criteria for the right quality of precision testing," Nielsen said.

Right now, diagnostic testing is very isolated in different countries, due to varying regulatory requirements, language barriers, and inability to access organizations in other regions, but the DXRX platform is intended to help break down those barriers. "There is no global standard or global reference standard for a certain biomarker for a certain disease," Hjort said. 

In addition, each section of the companion diagnostic industry tends to be siloed until close to drug launch. "DXRX has been designed to facilitate partnerships with all stakeholders involved in an end-to-end service for the development and commercialization of precision medicine diagnostics," Hjort said.

The recent Diaceutics report emphasized the importance of companion diagnostics stakeholders working together to promote tests for specific groups of oncology therapeutic products, as over the past 4 years multiple pharma competitors promoting PD-L1 testing has reduced the time required to reach the optimal testing rate (80 percent of patients tested) from 7 years to 3 years. 

In the same way pharma companies sponsor companion diagnostic tests for their drugs, Diaceutics wants to encourage them to sponsor EQA modules and control material for labs to make quality assessment more broadly available. By providing a place for these EQA organizations to communicate and collaborate with labs and other stakeholders, Hjort said it will "enable them to promote some of their products and their work, their training, controls, the EQA modules, and make that transparent to the entire precision medicine and diagnostic field."

The platform will also help with collaboration between organizations, such as Histocyte and the EQA agencies, allowing for the development and delivery of reference standard materials for quality assessment, Nielsen said.

Hjort added that training at laboratories is not always adequate, and many laboratories don't have the budgets to provide appropriate training for each companion diagnostic, which is why it's necessary for pharma companies to sponsor them. "It's difficult to keep up with all of the new information, guidelines, and developments around biomarker testing, being a single laboratory," she added.

The report also noted the importance of giving laboratories enough time to "achieve the standards required in order to offer the right test and interpretation in time for the launch of new treatments," making early quality assessment essential to ensure testing is accurate and all patients who need it receive it.

John Garratt, the director of CPQA-AQCP, emphasized the possibilities of the DXRX platform for creating specific quality metrics for laboratories through "EQA challenges and monitoring site positivity rates for therapeutic biomarkers." He also said the organization wants to use the "strong informatics support" at Diaceutics to design specific projects beneficial for both CPQA members and those in the DXRX community. Currently, the organization is collaborating with Diaceutics on a project to sponsor the HER2 biomarker modules for gastric cancer to assess efficiency of HER2 gastric cancer testing.

EMQN CIC, meanwhile, will offer its oncogene panel testing EQA scheme to DXRX members and use the data to "review the challenges faced by genomic laboratories in implementation of next-generation sequencing technologies," said Managing Director Simon Patton. He said the goal of the partnership is to broaden access to the agency's genomic testing activities, specifically "assessing the quality of high-throughput testing strategies, focusing initially on a small subset of commonly tested lung cancer biomarkers."

Hjort noted it may take time for other stakeholders to see the benefits of partnering with Diaceutics, saying "it's always difficult to get the first one on board," but as more agreements are announced, other companies will be able to see results firsthand.

"Everything comes back to the need for collaboration between all stakeholders involved in the patient journey," Hjort said. "It's not just about supporting a diagnostic test, there's much more into this." And through the DXRX platform, laboratories can also provide pharma companies with specific data to show them where exactly support is needed, with Diaceutics helping facilitate investments. "Pharma has a great amount of possibilities for investment," Hjort said. "What we need to do is focus their investment at the right time to deliver better patient outcomes" and at earlier phases of development.

Currently, "80 percent of educational interventional dollars spent by pharma is focused on" CDx tests or high-value NGS tests at the pre-treatment phase of a patient's diagnostic journey, the Diaceutics report said. As a result, significant changes can't be made to the full diagnostic journey because they're built on "a flawed precision testing ecosystem," and patients will not receive appropriate treatment.

Diaceutics is working with multiple pharma partners to show them the impact early investment could have on companion diagnostics and drug launches, she added. It has also onboarded multiple diagnostic companies and more than 2,500 laboratories in 51 different countries.

Although Diaceutics isn't currently working with any regulatory agencies, such as the US Food and Drug Administration, Hjort said the firm would like to collaborate with the regulatory bodies to create global standards for companion diagnostics, although she acknowledged they would need more data available before getting regulators involved.