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Exosome Diagnostics Launches Clinical Commercialization Program to Move Biomarkers to Dx Products

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NEW YORK (GenomeWeb) – Exosome Diagnostics announced last week the launch of a clinical commercialization program to help researchers bring exosome-based biosignature assays to the clinical lab.

Through the free program, called "Academic Bench to Clinical Diagnostics," or A to D, Exosome will help researchers port existing assays to the firm's patented exosome isolation and nucleic acid extraction system to increase sensitivity, and then guide the test through the regulatory and reimbursement process.

John Boyce, CEO and president of Exosome Diagnostics, told GenomeWeb in an interview that the firm is also bringing on a number of new hires, including a new head of regulatory affairs in Europe and the US, a head of sales for its companion diagnostics business, and 22 salespeople for soon-to-be-launched clinical diagnostics assays.

Boyce joined Exosome in early November. He was a co-founder of GnuBio and was CEO of that company until it was acquired by Bio-Rad for up to $110 million, then headed up the Cambridge location of Bio-Rad's Digital Biology Center until moving to Exosome.

Although the program can accommodate any exosome-based assay, A to D is particularly focused on ones that have been developed using the exoRNeasy kit distributed by Qiagen, Boyce said.

The components of that kit were developed at Exosome, and Qiagen distributes it exclusively for the research market as per a broad product development and co-marketing agreement that was expanded to include development of one non-invasive in vitro molecular diagnostic test.

However, Boyce pointed out that the partnership stipulates Exosome retains all rights to clinical use of the technology. Qiagen would thus not be able sell exoRNeasy kits to researchers who plan to use them for clinical lab-developed tests.

A Qiagen representative confirmed this element of the partnership, noting that Qiagen does have the rights to use the Exosome technology for one biomarker test on which both parties agree.

Boyce said he believes the academic research community will now embrace the opportunity to bring assays to market.

"I've seen a lot of great biomarkers over the years, a lot of great potential tests, and I've seen publications come out of that, but unfortunately that's kind of where it stopped," he said.

This may be because of the daunting regulatory process or the de rigueur partnering for commercialization.

Boyce said the firm's message to researchers is, "If you're using [the exoRNeasy] kits ... and you have a signature from that, bring that to us, because Qiagen only has the rights to sell it to the research market and we have a solution in-house that actually has enhanced performance, can get you a stronger signal, and is easier to implement for the clinic."

Exosome's in-house development group, which is also expanding, will then assist in porting the exoRNeasy-based test to the Exosome solution, which is purportedly manufactured to enable clinical use and is only available through the company directly.

The regulatory department, which is also making new hires, Boyce noted, will then work to move the test through to a commercial product in Europe, the US, or both. The firm also would have the option of offering the test instead as an LDT in its CLIA lab.

In exchange, researchers will receive royalties from test sales. They may also be potential future customers should they wish to keep using the test they originated, but Boyce said there will be discounts offered.

Potential customers might include researchers at the University of Melbourne, for example, who are studying an exosome-based microRNA biosignature predictive of Alzheimer's disease. That group uses an exosome purification product from Norgen Biotek, however, and Boyce pointed out that Exosome will first focus on tests already using the Qiagen exoRNeasy kit.

"They've been a great partner seeding the RUO and research market for us," he explained.

Exosome also raised $27 million in Series B financing in March, and announced another $17.6 million raised in September. Boyce said the firm will soon be closing out the full B round. "There's significantly more money coming in, and we're going to be announcing the close of that fairly soon," said Boyce, who added, "We have committed investors with significant resources, they're fairly well committed to not only this round but any additional funding as well, so we really have the pockets to expand."

Exosome's business architecture

Ultimately, the A to D program will help Exosome build up a menu of clinical diagnostic assays with external partners. However, Boyce said it is supplemental to other main revenue drivers, namely the firm's internal clinical diagnostics and companion diagnostics businesses.

On the clinical diagnostics front, the firm has been working on oncology panels as previously reported by GenomeWeb. One was previously described as a solid tumor diagnostic, but Boyce said the firm is now considering it a fusion panel.

"We're pulling both the DNA and the RNA down, so we're also getting fusions as well," he said, noting the current panel detects 26 genes and around 20 fusions. Cell-free DNA-based tests cannot detect these fusions, so Boyce said he believes this will differentiate the Exosome solution from competitors.

"The diagnostics team has tests that are actionable and already have CPT codes, so we're selling into a market that's well known and we'll probably have a larger menu than most any company out there in the liquid biopsy space," Boyce said.

A group at UCSD that has worked with Exosome in the past is developing the method for glioma diagnosis, as previously described. Specifically, they have been examining cerebrospinal fluid and blood from patients with brain tumors to search for extracellular RNA signatures in exosomes, as well as investigating different competing technologies for exRNA biomarker detection, including qPCR, digital PCR, and exome sequencing. Whether this assay will become part of Exosome's oncology offering is unclear.

The firm is also now fielding development requests from pharmaceutical companies and is beefing up its companion diagnostics team.

The aforementioned fusion panel can be expanded to include up to 88 genes and additional fusions. "We give the pharma companies the ability to pick which genes they want on there, and there's different groupings of genes based on common druggable pathways," Boyce said.

Ultimately, Exosome'stechnology, which includes sample prep as well as proprietary algorithms and analysis, is "platform agnostic," Boyce said, and depending on the test the samples can be queried with PCR or sequencing.

"We're now starting to evaluate with the clinical community [whether we] should standardize to one platform," Boyce said, adding that this is driving investment interest from other firms interested in pushing development toward particular platforms.

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