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Arcis Biotechnology Developing Urine-Based mRNA Assay for Prostate Cancer Screening

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NEW YORK (GenomeWeb) – Arcis Biotechnology is aiming to raise £2 million (about $2.8 million) in a financing round to further develop a multiplex RNA-biomarker prostate cancer screening test.

The UK-based firm plans to use raised funds to finalize the prostate cancer test for use with patient urine samples by using its proprietary technology for stabilization of genetic material. Acris has already raised about £690,000 in capital for the assay.

Lead by Calculus Capital, Arcis' current investors include venture capitalists and high net worth investors, the company said. The firm has also applied to Innovate UK for additional grant funding and plans to hear back by late March.

Founded in 2010, Arcis has developed sample prep technology that extracts and preserves genetic material from blood, saliva, and tissue samples. More recently, the company has shown that the technology works with urine samples. First, the firm's lysing solution pierces cells and causes them to release genetic material. Any DNA or genetic material that comes into contact with the lysing solution will change its conformation from helix to a coiled state.

Initially attempting to amplify the genetic material in the coiled state, Arcis instead found it was easier to use a proprietary buffer to remove the nucleic acid chelation and unwind the DNA/RNA for PCR or RT-qPCR. The firm claims that the buffer mops up any PCR inhibitors that may have carried over from the previous step.

Arcis' first step requires 5 milliliters and extracts the RNA in about 10 minutes, depending on the contents within individual samples.

Receiving a £160,000 grant from Innovate UK in Jan 2017, Arcis has since partnered with UK charity the Prostate Project and the University of Surrey in Guildford, England to accelerate the test's development. Arcis has also used the grant to assess the technical feasibility of extracting and stabilizing mRNA directly from urine.

Arcis CSO Jan Rogers said that collaborating with both groups allowed the firm to prove that it could preserve extracted genetic material in clinical samples and detect mRNA biomarkers in urine samples.

"In the last twelve months, we've proven that we can stabilize these samples for long periods of time directly from clinical samples" Rogers said. "We've been able to detect urine biomarkers from prostate cancer patients."

Rogers explained Arcis' assay detects common biomarkers including prostate-specific antigen (PSA), prostate-cancer antigen 3 (PCA3), beta-actin, and engrailed-2 (EN2) through qPCR and real-time qPCR, in addition to an undisclosed novel mRNA biomarker that Arcis is in the process of patenting. She declined to comment on the assay's sensitivity or specificity.

University of Surrey professor Hardev Pandha, whose lab discovered the novel mRNA biomarker, has partnered with Arcis to develop the diagnostic test. He explained in an email that PCA3 and PSA have been of limited utility in terms of sensitivity and specificity. On the other hand, he co-authored a study published in 2011 that demonstrated that EN2 can act as a viable urine biomarker for prostate cancer, with a sensitivity of 66 percent and specificity of 88 percent. He believes that evaluating of all four biomarkers will allow the team to see if there is added diagnostic value with PSA and PCA3.

Panda also explained that EN2 and PCA3 have not been developed in blood tests so far, whereas PSA blood-based tests have been used by researchers since the mid 1980s.

Regarding current cancer samples, Rogers emphasized that the company has "only tested samples where patients have presented indicators, because there's a high risk of cancer."

While current samples to date have been provided by the Prostate Project, Acris aims to test larger populations of cancer patients. Pandha explained that the team plans to test samples from a 160-patient study called ProCure, which contains a group of men with borderline PSA levels. Arcis researchers will compare urinary levels of EN2/PCA3/PSA alone or in combination in these patients to detect prostate cancer.

In terms of commercialization, Rogers believes that Arcis will initially market the test as a research-use-only tool "within the next year", and potentially seek clinical approval afterwards.

In addition to validating its own biomarkers, Arcis plans to work with external research teams who have validated biomarkers and are currently struggling to commercialize their technology. The firm believes it can bring liquid biopsies with validated biomarkers to market faster because of its simplistic and relatively cheap sample prep method.

Other molecular diagnostic companies have also been developing prostate cancer tests that examine RNA biomarkers in urine. Exosome Dx's ExoDx Prostate Intelliscore is an laboratory-developed exosome-based test that measures three exosomal RNA biomarkers in urine to assess the risk of high-grade prostate cancer in patients being considered for prostate biopsy.

Rogers envisions that the simplicity and preservation element of Arcis' test will enable patients to collect their own samples and send them to testing labs without worry of RNA decay.

"This [test] could help patients who have done treatment and have begun routine testing, as well as doctors monitoring patients with a likelihood of cancer," she said.