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Recent $22M Funding to Support OncoCell's Validation Study on Prostate Cancer Risk Score Assay

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NEW YORK – Wrapping up a $22 million Series B funding round earlier this month, liquid biopsy startup OncoCell MDx expects to launch an independent validation study on its noninvasive immuno-genomics RNA transcriptomics platform later this year. The Royal Oaks, Michigan-based firm will also use the proceeds to explore pan-cancer and other disease applications, such as active surveillance, neurodegenerative disease, and diabetes. 

OncoCell anticipates launching the assay — which currently analyzes 214 genes for prostate cancer risk — for research-use-only applications in the second half of 2020.

"The previous focus over the past seven years [has been] to establish data that proves how measuring RNA expression can help stratify disease earlier in the detection process," OncoCell CEO Mark McDonough said. "We are now accruing samples for active surveillance in the prostate cancer space." 

OncoCell's Subtraction-Normalized Expression of Phagocytes (SNEP) assay uses an algorithm to examine changes in gene expression of two immune cell types associated with prostate cancer, phagocytic CD14 and non-phagocytic CD2 cells. The algorithm removes genomic variations unrelated to prostate cancer and then identifies and validates prostate cancer-specific signatures.

While researchers noted in a feasibility study published earlier this year in Cancer Research that they could potentially test a variety of liquid samples using OncoCell's SNEP's technology, McDonough said that his team is initially focusing on developing an assay for blood samples. 

"You need to purify the populations of cells that are in deep circulation, and we haven't explored those type of cells in saliva and urine," McDonough explained. The sample types "have their own populations of inflammatory cells from their environment that we need to analyze differently." 

However, McDonough highlighted that OncoCell now aims to reduce the amount of blood needed for testing from 8 to 4 ml in the commercial version of the assay. Now running the SNEP assay on NanoString Technologies' nCounter Flex Analysis system, the team aims to produce diagnostic results on a sample within three to four days. 

Acknowledging that OncoCell's researchers had achieved "excellent results" with Illumina's HiSeq instrument on foundational work regarding the SNEP technology, McDonough noted that his team switched to NanoString's platform because of the tool's downstream flexibility.

"While [NanoString's] limitation of an 18-hour incubation time slows down our overall turnaround time, NanoString is building a portfolio of tests that might give us flexibility downstream," McDonough said. "There might be potential down the road for us to leverage call points, as if we were to build pan-disease tests with additional needed tests, we'd be able to offer those from the get-go." 

In addition, OncoCell said it swapped instruments because it was easier than performing targeted RNA-Seq, had a faster turnaround time, and had a lower cost per test. According to OncoCell CSO Kirk Wojno, using NanoString's platform allowed the team's machine-learning algorithm to whittle down the number of genes from over 22,000 to 214, enough to cover disease heterogeneity. 

OncoCell is currently performing a longitudinal clinical validity study examining active surveillance in a cohort of 634 prostate cancer patients. The firm is partnering with medical urology groups including UroPartners in Chicago, Comprehensive Urology (a division of Michigan Health Care Professionals), and Urology Austin, Texas to collect prostate cancer blood samples over a four-month recruitment period, followed by a monitoring period of 10 years. 

OncoCell also anticipates starting an additional independent validation study on the SNEP technology later this year, where it will partner with undisclosed academic and commercial groups to examine a separate cohort of prostate cancer patients on active surveillance. Despite being unable to disclose much about OncoCell's plans for the study, McDonough noted that the firm anticipates launching the commercial RUO version of the assay following the publication of the study's results. 

"While we can't reveal any partners yet for the [validation] study, I can say they will be major academic groups," said McDonough, who previously served as president and CEO of CombiMatrix and was named president and CEO of OncoCell this past April. "We are bullish that they will work with [OncoCell] because we think we have something here that can truly help stratify the patients as they're being monitored during active surveillance."

As OncoCell continues improving the SNEP technology for prostate cancer diagnostic and prognostic purposes, Wojno believes the team could eventually apply the tool to a broader range of diseases. He noted that the firm would initially target neurodegenerative disease diagnosis and potentially shift later toward detecting and monitoring a patient's risk for conditions like Alzheimer's, diabetes, and cardiovascular diseases. 

"We're strategizing on how to use a single blood test to answer multiple clinical questions, and we now have the ability to 're-mine' that data over time for multiple tests," Wojno said. 

While OncoCell has not determined a price for the envisioned SNEP prostate cancer assay, McDonough pointed to tissue biopsy-based tests offered by other companies including Myriad Genetics and Genomic Health (recently acquired by Exact Sciences), who he said have obtained Medicare reimbursement rates of about $3,800 to $4,000 per test. McDonough believes that having a noninvasive stratification tool that is "functionally equivalent" will allow OncoCell to secure "high reimbursement," but further noted that his team will need to perform additional clinical studies to prove the assay's utility. 

"We think there is a tremendous unmet need and commercial opportunity in prostate cancer, starting with active surveillance, but really through the whole continuum from screening toward radical prostatectomy and late-stage cancer," McDonough said.

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