Pillar Biosciences Receives CPT Code for FDA Approved OncoReveal CDx Pan-Cancer Solid Tumor IVD Kit
Pillar Biosciences Receives CPT Code for FDA Approved OncoReveal CDx Pan-Cancer Solid Tumor IVD Kit
"We are proud of achieving this milestone in the launch of oncoReveal CDx, which was the first FDA PMA-approved multi-cancer IVD kit launched in the market," said NATICK, Mass., Oct. 24, 2024 /PRNewswire/ -- Pillar Biosciences, Inc., the leader in Decision Medicine, today announced that they have been granted a unique CPT Proprietary Laboratory Analyses (PLA) code 0523U from the American Medical Association (AMA) for their FDA approved oncoReveal CDx pan-cancer solid tumor in vitro diagnostic (IVD) NGS kit.
馬薩諸塞州NATICk，2024年10月24日 /PRNewswire/ -- 決策醫學領導者Pillar Biosciences，Inc.今天宣佈，他們已獲得美國醫學協會(AMA)頒發的獨特CPt專有實驗室分析(PLA)代碼0523U，用於其FDA批准的oncoReveal CDx泛癌固體腫瘤體外診斷(IVD) NGS試劑盒。
oncoReveal CDx is a NGS based IVD kit that uses Pillar's proprietary SLIMamp (Stem-Loop Inhibition-Mediated amplification) technology for detection of single nucleotide variants (SNVs), insertions and deletions in 22 genes using DNA isolated from formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens. oncoReveal CDx has been FDA cleared on the Illumina MiSeq Dx.
oncoReveal CDx是一種基於NGS的IVD試劑盒，使用Pillar的專有SLIMamp（Stem-Loop Inhibition-Mediated amplification）技術，通過從福爾馬林固定石蠟包埋（FFPE）腫瘤組織標本中提取的DNA，檢測22個基因中的單核苷酸變體（SNVs）、插入和缺失。oncoReveal CDx已獲得Illumina MiSeq Dx的FDA清除。
The oncoReveal CDx assay kit is intended to provide pan-cancer tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for previously diagnosed cancer patients with solid malignant neoplasms. oncoReveal CDx has also been approved as a companion diagnostic to identify patients who may benefit from EGFR TKI therapy (class approval) in NSCLC and ERBITUX and VECTIBIX for KRAS in CRC.
oncoReveal CDx檢測試劑盒旨在提供泛癌腫瘤突變分析，供符合專業指導原則的合格醫護專業人員根據腫瘤學專業指南，爲先前診斷爲實體惡性新生物的癌症患者使用。oncoReveal CDx還獲得批准作爲伴隨診斷，用於識別可能從EGFR TKI療法（類批准）中受益的非小細胞肺癌患者和用於KRAS非小細胞肺癌患者的ERBITUX和VECTIBIX。
"We are proud of achieving this milestone in the launch of oncoReveal CDx, which was the first FDA PMA-approved multi-cancer IVD kit launched in the market," said Brian Wright, Chief Marketing Officer of Pillar Biosciences. "In partnership with Illumina, we have enabled rapid and affordable NGS testing to be performed locally in any NGS lab. We are committed to developing and bringing highly accurate, actionable, and reimbursable NGS testing to clinical laboratories and biopharmaceutical companies to help improve treatment decisions and deliver outcomes that are accessible to everyone, everywhere."
「我們爲推出oncoReveal CDx取得的這一里程碑感到自豪，這是市場上首次獲得FDA PMA批准的多癌症IVD試劑盒，」Pillar Biosciences首席營銷官Brian Wright說。「與illumina的合作，我們實現了可以在任何NGS實驗室本地進行快速和經濟的NGS測試。我們致力於開發和推出高度精確、可操作且可報銷的NGS測試，以幫助改善治療決策，並提供對每個人、每個地方都可接受的結果。」
About Pillar Biosciences
關於Pillar Biosciences
Pillar Biosciences is the leader in Decision Medicine, which is the utilization of highly accurate and sensitive next-generation sequencing (NGS) testing technology to generate data that optimizes selection of precision therapies for cancer patients, from tumor profiling to therapy selection, and recurrence monitoring. Pillar's NGS testing solutions are powered by its proprietary SLIMamp and PiVAT technologies, helping to localize the testing process, reduce diagnostic costs and improve access and efficiency of complex NGS testing for clinicians, prescribers, and patients globally. The company has more than 20 NGS testing kits available in IVD or RUO formats, with multiple panels in various stages of development. Pillar Biosciences has operations in Natick, MA. For more information visit pillarbiosci.com and connect with us on LinkedIn.
Pillar Biosciences是Decision Medicine領域的領導者，其利用高度準確和敏感的下一代測序（NGS）檢測技術產生數據，爲癌症患者優化精準治療的選擇，從腫瘤分型到治療選擇和復發監測。Pillar的NGS檢測解決方案由其專有的SLIMamp和PiVAt技術驅動，有助於定位測試過程，降低診斷成本並改善全球臨床醫生、處方者和患者的複雜NGS檢測的獲取和效率。該公司有超過20個NGS檢測試劑盒可用於IVD或RUO格式，有多個面板處於不同階段的開發中。Pillar Biosciences位於馬塞諸塞州的Natick。欲了解更多信息，請訪問pillarbiosci.com並在LinkedIn上與我們聯繫。
SOURCE Pillar Biosciences, Inc.
Pillar Biosciences，Inc.來源。
