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Personal Genome Diagnostics to Build Commercial Infrastructure, Drive Partnerships With New Funding

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NEW YORK – After raising $103 million in a Series C funding round earlier this month, cancer sequencing firm Personal Genome Diagnostics now aims to invest in its commercial infrastructure and strike more agreements with diagnostic and pharmaceutical firms.

The Baltimore-based firm also expects to release an expanded liquid biopsy panel later this year that it believes will help pharmaceutical partners perform blood-based biomarker discovery work for measuring cancer drug response.

CEO Megan Bailey noted that PGDx has now raised a total of over $200 million to develop and commercialize its suite of Elio products since the firm was founded in 2010.

PGDx currently markets its Elio Tissue Complete next-generation sequencing (NGS) test, a 507-gene panel kit that is cleared by the US Food and Drug Administration and identifies single-nucleotide variants (SNVs), small insertions and deletions, amplifications, rearrangements, microsatellite instability (MSI), and tumor molecular burden (TMB) in DNA from patient tissue samples. The assay includes biomarkers to help clinicians identify appropriate targeted cancer therapies and immunotherapies.

The firm also offers a liquid biopsy NGS assay called Elio Plasma Resolve, a 33-gene research use only (RUO) kit that detects SNVs, amplifications, rearrangements, and MSI status in circulating cell-free DNA to guide therapy selection. 

Bailey said that the firm's strategy is to decentralize comprehensive genomic analysis capabilities to local molecular laboratories and hospitals where patients are being treated.

Going forward, PGDx aims to invest in its commercial infrastructure, which will include hiring more sales staff and increasing staffing in "functions that support our commercial operations," she said. By doing so, the firm believes it will have the resources to place its products in more labs across the US and the rest of the world.

In addition to the US, PGDx has shipped its assays —which have both received the CE mark — to the UK, Japan, China, and Germany, and has helped customers get them up and running. While PGDx expects to expand its presence further in the EU, Bailey said that the firm has seen strong performance of the assays in multiple geographic regions.  

PGDx has achieved several milestones in the past year, including a 510(k) clearance from the FDA for the Elio Tissue Complete assay. The firm also received a final local coverage determination from the Centers for Medicare and Medicaid last fall for the assay, which Bailey said is reimbursed at roughly $3,000 per test and has seen strong demand across a wide spectrum of customers and cancer types.

While the Elio Plasma Resolve assay received Breakthrough Device Designation from the FDA in 2018, Bailey said that PGDx has plans to apply for 510(k) clearance for the test but declined to disclose a timeline.

PGDx also aims to maintain its position in the precision medicine space by using the recent funding to adapt its platform to expand its pharma business, she said. 

To that point, PGDx is developing a broader liquid biopsy panel for blood-based biomarker discovery that Bailey described as more akin to the Elio Tissue Complete than the Elio Plasma Resolve. The firm believes that test will help its pharma partners measure tumor response to their drugs as they shape their clinical biomarker strategies.

According to Bailey, PGDx expects to launch the assay as a RUO kit later this year.

"We are [also] looking at options like bringing products to market that not only help oncologists make initial treatment decisions but [also] help patients make decisions during their clinical journey," she said, but didn't elaborate on those plans.

Recent partnerships

As PGDx continues to work on its commercial growth and develop new panels, the firm has also been fleshing out partnerships with academic and diagnostic groups to increase access to its technology through companion diagnostic projects and streamlined bioinformatics workflows.

Earlier this week, for example, the company announced an agreement with Philadelphia-based Fox Chase Cancer Center to use the Elio Plasma Resolve test in cancer patients.

"Our goal is early identification of tumor responses to therapy, drug resistance mutations, and metastasis, or recurrence, enabling rapid revision of the patient's treatment plan informed by changes in the molecular status of their disease," Don Baldwin, associate professor of pathology at Fox Chase Cancer Center, said in a statement.

Bailey said she envisions the agreement as a long-term relationship for both parties but declined to provide financial or other details of the collaboration. "By working with a leading cancer center like Fox Chase, we will be able to collaborate and review data to understand how our assays are influencing treatment decisions and improving the standard of care," she said.

A year ago, PGDx partnered with the Mayo Clinic to evaluate the firm's technology to help the hospital improve cancer treatment by spotting effective therapy options and improve response monitoring. While Bailey noted that the project "has progressed well," she did not elaborate. 

PGDx also said last month that it is working with Almac Diagnostic Services to provide pharmaceutical customers with access to its tumor profiling assays.  Bailey said that the partnership will focus on increasing the number of patients tested using the assays in the UK and in the EU.

Also in January, PGDx signed a non-exclusive agreement with Qiagen to provide clinical decision support to users of PGDx's assays. Specifically, the firm will offer Qiagen's QCI Interpret One as an option for quick evidence-based reporting for its NGS tests.

Bailey said that PGDx's oncology products fully automate the bioinformatics analysis, and that genomic data can then be integrated with Qiagen's clinical interpretation software.

"Historically, that part of the workflow has been very challenging [because] it's a large magnitude of data, requires high levels of expertise to review and filter to basically deliver actionable answers," Bailey explained. "Our product eliminates that challenge by fully automating the data analysis end of it and producing …. the variant calls and other actionable data out of that sample."

Bailey pointed out that Qiagen has modules that can help match patients to specific clinical trials, based on genomic data that PGDx's assay produces.

"We would help labs integrate the data [that] our system produces into a software suite like Qiagen's Interpret One to then give that end-to-end clinical decision support information back to oncologists," she added. 

PGDx believes that combining its platform with Qiagen's software capabilities will help the firms drive greater access to local testing, as well as make the data more clinically useful and better manageable for care decisions. 

As part of the agreement, PGDx joined Qiagen's "Digital Partnership" program that is designed to expand the market for the firm's bioinformatics products.

PGDx also signed a comarketing agreement with Genosity last September to integrate the Elio Tissue Complete assay in that firm's software and professional consulting services.

"When we partner with pharma or specific institutions, they may have certain studies they want to execute around a specific tumor type or specific biomarker they're looking at," Bailey said. "One of the things that has driven significant interest in the market [is] the fact that [the tests] are comprehensive and don't have to be used in a tumor-specific way."

She noted that PGDx has seen even growth between its assay business for the lab market and its pharma-partnering business. At the same time, the company expects that the product side will be the larger contributor of revenue over the next five years as the firm scales up and addresses multiple markets.

"When you're talking about addressing therapy selection across solid tumor indications and have both the tissue and liquid biopsy option, the market and patient impact potential is enormous on the product side," Bailey explained.

However, she emphasized that PGDx's pharma business will always be strategically important because it helps the firm understand what the clinical utility in the market will be when the products are offered on a routine diagnostic basis.