ORI Capital, a quantamental healthcare fund manager focused on investing in disruptive healthcare companies globally, announced today the U.S. Food and Drug Administration (FDA) has given its portfolio company, Pillar Biosciences Inc. ("Pillar"), Premarket Approval (PMA) for Pillar's oncoReveal™ Dx Lung and Colon Cancer Test (ORDx-LCCA). The test is an NGS tissue-based companion diagnostic test for the qualitative detection of somatic mutations in DNA, derived from non-small cell lung cancer and colorectal cancer.
Currently the majority of cancer patients do not benefit from precision medicine as the first line treatment given cancer diagnostic tests have significant limitations including accuracy, turnaround time and affordability. Pillar's test will be able to address these significant challenges.
Pillar is an innovative next-generation sequencing (NGS) in vitro diagnostic company incorporated in 2014 with a mission to make precision medicine the first choice for all cancer patients. The Company's test is the first:
NGS-based PMA CDx kit for targeted therapies across two cancer types
NGS-based companion diagnostic test for expanded EGFR TKI therapies in patients with non-small cell lung cancer
PMA CDx approval from the FDA, among Illumina's IVD partners
ORI Capital has a strong focus on investing in companies developing innovative cancer treatments. Despite many recent breakthroughs in cancer therapies, precision medicine has not been widely used in treating cancer, due to the lack of fast, accurate, and cost-effective cancer testing products. Pillar is seeking to change this and was ORI Healthcare Fund's first investment. Since Pillar's Series A financing in 2016, ORI Capital has been supporting the Company through the development and regulatory approval process for its innovative products.
Simone Song, Founder & Senior Partner at ORI Capital commented, "For a young company such as Pillar to have a PMA from the FDA is like climbing Mount Everest. The founders of Pillar have had the PMA goal in mind since the very beginning, as they knew this could mean making precision medicine the first line treatment for all patients,"
Simone continued, "We at ORI share the same vision and goal with the Pillar team. We have been supporting this Company since its Series A financing, including sharing with Pillar strategic insights, competitive landscape analysis, follow-on financing plans and ultimately working with them to reach this juncture. We are thrilled at this achievement by Pillar and are immensely proud of their team. We know what this breakthrough test can mean for cancer patients. This test can change how cancer treatment decisions are informed."
"We are committed to providing high quality and accurate IVD tests to enable better treatment decisions for cancer patients," said Gang Song, Ph.D., Founder and CEO at Pillar. "Our FDA-approved product can be used by any lab that conducts NGS testing, making precision medicine accessible to all cancer patients."
"We believe high quality specialty tests should be provided closest to where a patient resides, especially for a cancer patient. We look forward to accelerating our future development plans and bringing more innovative FDA-approved products to providers and partners in their local community setting," said Zhaohui Wang, Ph.D., Co-founder and Chief Scientific Officer at Pillar.
Together with portfolio companies such as Pillar, ORI Capital strives to advance programs in diagnostics, therapeutics and drug delivery to combat the most lethal diseases including cancer, acute conditions caused by metabolic disorder and neuro degenerative diseases.
About ORI Capital
ORI Capital is a quantamental healthcare fund manager focused on investing in disruptive technologies in the healthcare industry globally. From a modality point of view, ORI Capital focuses on diagnostics, therapeutics and drug delivery. From a disease point of view, ORI Capital focuses on the ones that are with the highest mortality. ORI Capital combines fundamental research executed by human intelligence with quantitative analysis executed by AI-enhanced research platform throughout the entire investment process. By tracking and analyzing data synthesized from over 15,000 companies, 1,000 KOLs, and 1,000 fund managers, ORI Capital i...
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