The U.S. FDA has granted investigational device exemption approval for the use of Personal Genome Diagnostics Inc.’s (PGDx) elio tissue complete assay in a Merck & Co. Inc. trial of a Keytruda (pembrolizumab)-based combination therapy. Specifically, the assay will be used during the trial to analyze genomic markers to direct patient enrollment and stratification.  

“We’re pleased with the FDA’s decision to approve PGDx’s elio tissue complete assay for this trial, as it validates the robustness of the test and reinforces the role of diagnostic biomarkers in investigating treatment strategies for patients living with cancer,” said Doug Ward, CEO of Baltimore-based PGDx. 

The decision comes as the company has made a lot of strides. “Our elio product is actually … in development in the U.S. It is CE marked as of a few months ago. And we’ve made substantial progress towards other regulatory clearances and filings.” John Simmons, vice president of translational medicine at PGDx, told BioWorld. “But what we’ve been able to do is to leverage that testing in clinical trials,” such as this one. 

What sets it apart 

“What our elio product does and what sets it apart is it’s an end-to-end solution, so it’s the lab chemistry that’s optimized, put in a kit, all the protocols are developed at PGDx and then transferred to the molecular lab that’s going to run the test,” explained Simmons. “And then all of our bioinformatics, artificial intelligence, algorithms and computational prowess is then leveraged in software that fits locally on a server to automatically process all of that sequencing data and come up with a patient report.” 

While he declined to discuss a potential length of the trial, he noted it was biomarker driven. He said that the company submitted for the IDE approval to report out some additional enrollment and stratification criteria in order to help determine if patients were eligible for the trial.  

One of the benefits of a test like elio tissue complete, he continued, is that it is comprehensive. “So, out of the very limited amount of tissue that you would get in, for instance, non-small-cell lung cancer, you can get many different markers reported, so tumor mutational burden, MSI [microsatellite instability], but also rearrangements like ALK … point mutations like EGFR – all of those things [that] have clinical significance and actionability in one cancer specifically and in other tumor types as well.” 

Johns Hopkins spinout 

The company started roughly nine years ago as a spinout of Johns Hopkins. “And it first began as a CAP/CLIA lab doing clinical NGS testing from tumor tissue,” Simmons noted. It added in plasma testing a few years later, then, roughly four years ago, the company pivoted, recognizing that “the time for NGS testing for cancer patients was really entering a time of broadening clinical utility.” The company determined that a solution was needed to be run in labs globally, not just in one central lab. 

Since then, it has teamed up with several pharma companies. Aside from Merck, Simmons noted that PGDx has worked with companies such as Takeda, Blueprint Medicines Corp. and Five Prime Therapeutics Inc. He noted that the company has had a long relationship with Merck, working across the drug development continuum.  

This latest news comes a little over two months after the company reported the CE mark for the PGDx elio tissue complete assay. That followed another green light in Europe that the company unveiled in March – specifically, that it had gained the CE mark for the PGDx elio plasma resolve. That product is a qualitative in vitro diagnostic test that uses targeted high-throughput, parallel-sequencing technology to detect single nucleotide variants, small insertion/deletions, amplifications, rearrangements and MSI in a broad multi-gene panel in circulating cell-free DNA isolated from plasma samples.  

Also, in July 2018, the company reported that the PGDx elio plasma resolve had gained a breakthrough device designation from the FDA. 

PGDx also has attracted investors. In early 2018, for example, the company closed a series B financing for $75 million, earmarking the funding to advance its in vitro diagnostic genome testing. Later that fall, Innovatus Capital Partners LLC said it had entered a financing agreement with the company. Innovatus noted that it would provide up to $42 million in capital to back PGDx’s plan to bring regulated in vitro diagnostic genome testing to cancer patients and their physicians worldwide. 

Keytruda sets new mark 

Keytruda has been a moneymaker for Merck. During its third-quarter earnings call in October, the company noted that the product’s sales had risen 64% year-over-year, exceeding $3 billion in a quarter for the first time.  

Earlier this week, the company reported that the FDA had accepted and granted priority review for a new supplemental BLA. The company is hoping for an approval of Keytruda as a monotherapy for patients with Bacillus Calmette-Guerin-unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in-situ with or without papillary tumors who are ineligible for or have elected not to undergo removal of the bladder. This application is slated for discussion at the Dec. 17 meeting of the FDA’s Oncologic Drugs Advisory Committee. 

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