Exosome Diagnostics Launches the MedOncAlyzer™ Pan-Cancer Panel

Waltham, Mass., Aug. 09, 2017 -- Exosome Diagnostics, a leader in the liquid biopsy market, today announced the launch of the MedOncAlyzer 170, the first liquid biopsy pan-cancer panel that simultaneously interrogates exosomal RNA (exoRNA) and circulating tumor DNA (ctDNA) in a single assay. The MedOncAlyzer 170 is a targeted panel for tumor profiling that identifies clinically actionable and functionally important mutations across multiple cancer types starting from a small volume (≥ 0.5ml) of patient blood or plasma.

“The MedOncAlyzer is the only cancer panel on the market that interrogates information on both RNA and DNA, giving it a higher sensitivity compared to ctDNA assays when profiling early stage and late stage cancers in plasma,” said Johan Skog, Chief Science Officer of Exosome Diagnostics. “ctDNA-only solutions are seeing their most accurate measurements in late stage cancers. The primary drivers of ctDNA release into the bloodstream are apoptosis and necrosis of tumor cells. Existing solutions that rely on ctDNA alone are building a profile of the tumor that is biased towards consequences of cell death. Exosomes, in contrast, are actively released by living cells including viable tumor cells. The MedOncAlyzer, with its unique ability to co-isolate RNA and DNA, is balanced to produce accurate, highly sensitive identification of rare variants through all stages of disease progression and treatment, including RNA variants that cannot be seen on ctDNA.”

The MedOncAlyzer 170 panel leverages the proprietary Exosome Diagnostics technologies including nucleic acid co-isolation, target capture and bioinformatics to yield unprecedented sensitivity and scope:

• 170 clinically actionable and functionally relevant gene targets
• Capture and sequencing of complete coding regions for all targets
• 99.9% sensitivity for mutations at allele fractions of ≥ 0.1%
• Ability to detect RNA-specific events such as gene fusions and splice variants
• Complete panel coverage from ≥ 0.5ml of starting material (plasma)
• Double the nucleic acid extracted per ml of sample volume versus ctDNA alone
• 82,000 COSMIC variants interrogated

“The MedOncAlyzer assay consistently produces on average three-fold more total nucleic acid concentration per ml of starting plasma over ctDNA-only protocols,” said John Healy, VP of Informatics at Exosome Diagnostics.  “The overall sensitivity of the MedOncAlyzer assay is, by definition, greater than any products that look at ctDNA alone. As with any panel, we can sequence at high coverage depths to increase measurement accuracy of rare events. However, the sensitivity of this downstream analytic is limited by the absolute number of molecules carrying rare mutations that might have been captured in the upstream isolation step. Our critical advantage in this co-isolation stage means that the MedOncAlyzer is making the most efficient use of sequencing coverage. This has allowed us to vastly increase the breadth of our panel without sacrificing depth of sequencing coverage.”

“We are already experiencing tremendous demand for the MedOncAlyzer panel from our pharma partners and academic collaborators,” said John Boyce, CEO of Exosome Diagnostics. “The value of our ability to perform such comprehensive tumor profiling from as little as 0.5ml of starting material is clear. The MedOncAlyzer has uniquely positioned Exosome Diagnostics to realize the full potential locked in our partners’ sample biobanks without sacrificing precious material. The MedOncAlyzer is a transformative technology ensuring that applications including biomarker discovery, companion diagnostic development and validation efforts are no longer compromised by the limited molecular profiles gleaned from ctDNA alone. Armed with complete molecular profiles, our pharma partners are further empowered to engage in fully informed clinical trial design and recruitment.”

For more information about the MedOncAlyzer 170, please email [email protected]

About Exosome Diagnostics

Exosome Diagnostics is a privately held company focused on developing and commercializing revolutionary biofluid-based diagnostics to deliver personalized precision healthcare that improves lives. The company’s novel exosome-based technology platform, ExoLution™, and point of care instrument for protein capture and analysis, Shahky^TM, can yield comprehensive and dynamic molecular insights to transform how cancer and other serious diseases are diagnosed, treated and monitored. Visit www.exosomedx.com to learn more.

ExoDx is a registered trademark of Exosome Diagnostics, Inc. Exosome Diagnostics and ExoLution are unregistered trademarks of Exosome Diagnostics, Inc.

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A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/46efda58-9dba-422e-85f5-69d521a67481

Dan Baughman
Exosome Diagnostics
248 613 2247
[email protected]