Bionano Laboratories Announces New Category I CPT Code for OGM Use in Hematological Malignancy Analysis
Bionano Laboratories Announces New Category I CPT Code for OGM Use in Hematological Malignancy Analysis
SAN DIEGO, June 17, 2024 (GLOBE NEWSWIRE) – Bionano Laboratories, a clinical laboratory services business of Bionano Genomics, Inc. (Nasdaq: BNGO), today announced the editorial panel of the American Medical Association (AMA) established a new Category I Current Procedural Terminology (CPT) code for the use of optical genome mapping (OGM) in cytogenomic genome-wide analysis to detect structural and copy number variations related to hematological malignancies. The CPT code is a key component in obtaining reimbursement for the OGM-Dx HemeOne laboratory developed test (LDT) from third party payers. The Category I CPT code is expected to be included in the next CPT codebook and to be effective January 1, 2025.
2024年6月17日,生物纳米实验室(Bionano Laboratories,BNGO纳斯达克)的临床实验室服务业务宣布,美国医学协会(American Medical Association,AMA)的编辑委员会为使用光学基因组图谱(OGM)进行细胞遗传学基因组范围分析以检测与血液恶性肿瘤相关的结构和拷贝数变异建立了新的一类CPT(Current Procedural Terminology)代码。 CPT代码是获得第三方支付器支付OGM-Dx HemeOne实验室开发测试的关键组件。分类的一类CPT代码预计将包含在下一个CPT代码册中,并于2025年1月1日生效。
The establishment of a new Category I CPT code for OGM implies that it has met the standards of acceptance by the medical community, in contrast to a Category III code, which is generally applied to emerging technologies. As part of the application review process, the panel collects input from stakeholders across the health care community to ensure CPT content reflects the coding and data-driven demands of modern health care.
为OGM建立新的一类CPT代码意味着它已满足医学界的接受标准,与通常适用于新兴技术的三类CPT代码形成对比。作为申请审核流程的一部分,该委员会收集来自医疗保健社区各方对CPT内容反映现代医疗保健的编码和数据驱动需求的意见。
"We believe this approval of a Category I CPT code for OGM is a game changer for clinical OGM testing. The criteria that the AMA uses for Category I CPT code approval is rigorous, and this approval is significant," said Donna Polizio, global head of market access at Bionano Laboratories. "OGM-Dx HemeOne is used to detect all classes of structural variants that are traditionally tested by multiple methods such as karyotyping, chromosomal microarray, and fluorescence in situ hybridization (FISH) analysis. We believe the CPT code is an important step forward for Bionano Laboratories and its efforts to obtain reimbursement for this assay and that establishing a Category I CPT code will raise the awareness and utility of OGM."
“我们认为美国医学协会批准OGM这一类别I CPT代码是临床OGM测试的一个里程碑事件。AMA为CPT代码通过批准使用的标准是严格的,这种批准是重要的,”Bionano Laboratories全球市场准入部门负责人Donna Polizio说。“OGM-Dx HemeOne用于检测传统上由多种方法如核型分析、染色体微阵列和荧光杂交(FISH)分析测试的所有结构变异类别。我们认为,CPT代码对Bionano Laboratories和其获取对该测试的报销的努力是一个重要的前进步伐,并且建立一类CPT代码将提高OGM的意识和实用性。”neofleX这一新型探针在组织切片的多组学空间生物数据方面,通过针对蛋白质、糖类、代谢物、脂质、内源性肽、除草剂和现在的RNA/DNA,提供了更多像素级解析信息。这种额外的多组学环境提供了关于细胞状态、功能、结构和蛋白质活性的重要相邻信息,适用于肿瘤学和神经学等各种研究领域。关于Bionano Laboratories:OGM测试结合了全面的测试组合与周到易用的支持选择,为基础、应用和临床研究提供了OGM的直接访问。Bionano Laboratories提供基因答案和支持的访问,并利用尖端技术推进世界基因组的视野。Bionano Laboratories提供直接访问OGM的行业基础,利用专有的等电聚焦(ITP)技术提供核酸提取和纯化解决方案。通过其名为Lineagen, Inc. d/b/a Bionano Laboratories的业务,公司还提供基于OGM的诊断测试服务。
About Bionano Laboratories:
关于Bionano Laboratories:
Bionano Laboratories provides access to genetic answers and support utilizing cutting-edge technologies to advance the way the world sees the genome. Its clinical diagnostics services offer optical genome mapping (OGM) testing that combines a comprehensive testing portfolio with thoughtful and accessible support options. Bionano Laboratories also offers direct access to OGMfor applications across basic, translational and clinical research. For more information, visit www.bionanolaboratories.com
Bionano Laboratories通过使用先进技术提供基因答案和支持,推进人们对基因组的认识。其临床诊断服务提供光学基因组图谱(OGM)测试,将全面的测试组合与深思熟虑和易于理解的支持选项相结合。 Bionano Laboratories还为基础研究,翻译研究和临床研究的应用提供直接使用OGM的途径。更多信息请访问www.bionanolaboratories.com
About Bionano
关于Bionano
Bionano is a provider of genome analysis solutions that can enable researchers and clinicians to reveal answers to challenging questions in biology and medicine. The Company's mission is to transform the way the world sees the genome through optical genome mapping (OGM) solutions, diagnostic services and software. The Company offers OGM solutions for applications across basic, translational and clinical research. The Company also offers an industry-leading, platform-agnostic genome analysis software solution, and nucleic acid extraction and purification solutions using proprietary isotachophoresis (ITP) technology. Through its Lineagen, Inc. d/b/a Bionano Laboratories business, the Company also offers OGM-based diagnostic testing services.
Bionano是一家基因分析解决方案提供商,可使研究人员和临床医生揭示生物学和医学方面的难题。公司的使命是通过光学基因组图谱(OGM)解决方案,诊断服务和软件改变人们看待基因组的方式。该公司为基础研究,翻译性研究和临床研究的应用提供OGM解决方案。该公司还提供行业领先的平台无关基因组分析软件解决方案以及使用专有的等电聚焦技术进行核酸提取和纯化解决方案。通过其Lineagen,Inc.地/ b / a Bionano实验室业务,该公司还提供基于OGM的诊断测试服务。
For more information, visit www.bionano.com, www.bionanolaboratories.com or www.purigenbio.com.
Forward-Looking Statements of Bionano Genomics
Bionano Genomics的前瞻性声明
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believe," "expect," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the ability and utility of the Category I CPT code to drive use and adoption of the OGM-Dx HemeOne test and other OGM-based tests; the ability of the OGM-Dx HemeOne test to obtain coverage and reimbursement; whether the Category I CPT code will ultimately be important for clinical OGM testing; and any other statements that are not of historical fact. Each of these forward-looking statements involves risks and uncertainties. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the risks and uncertainties associated with: the impact of geopolitical and macroeconomic developments, such as recent and potential future bank failures, the ongoing conflicts between Ukraine and Russian and Israel and Hamans, and related sanctions, and any global pandemics, on our business and the global economy; the failure of the Category I CPT code to drive use and adoption of the OGM-Dx HemeOne test and other OGM-based tests; the failure of the OGM-Dx HemeOne test to obtain coverage and reimbursement; the failure of the Category I CPT code to ultimately be important for clinical OGM testing changes in the competitive landscape and the introduction of competitive technologies or improvements to existing technologies; changes in our strategic and commercial plans; our ability to obtain sufficient financing to fund our strategic plans and commercialization efforts and our ability to continue as a "going concern"; the ability of medical and research institutions to obtain funding to support adoption or continued use of our technologies; and the risks and uncertainties associated with our business and financial condition in general, including the risks and uncertainties described in our filings with the Securities and Exchange Commission, including, without limitation, our Annual Report on Form 10-K for the year ended December 31, 2023 and in other filings subsequently made by us with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.
本新闻稿包含根据1995年私人证券诉讼改革法案发布的前瞻性声明。类似"相信","期望"等的语句(以及其他涉及未来事件,条件或情况的词语或表达方式)传达了未来事件或结果的不确定性,并旨在识别这些前瞻性声明。前瞻性声明包括关于我们意图,信念,投影,展望,分析或当前期望的声明,包括但不限于:分类的一类CPT代码在推动OGM-Dx HemeOne测试和其他基于OGM的测试的使用和采用方面的能力和效用; OGM-Dx HemeOne测试获得报销和支付的能力;分类的一类CPT代码是否最终对临床OGM测试至关重要;以及任何其他不属于历史事实的声明。这些前瞻性声明中的每个声明都涉及风险和不确定性。实际结果或发展可能与这些前瞻性声明中预期或暗示的结果或发展有所不同。可能导致产生差异的因素包括:地缘政治和宏观经济发展(例如最近和未来可能发生的银行倒闭,乌克兰和俄罗斯以及以色列和哈曼之间持续的冲突以及相关制裁以及任何全球大流行)对我们的业务和全球经济的影响;分类的一类CPT代码未能推动OGM-Dx HemeOne测试和其他基于OGM的测试的使用和采用; OGM-Dx HemeOne测试未能获得报销和支付;分类的一类CPT代码最终对临床OGM测试非常重要;竞争格局的变化和竞争技术的引入或现有技术的改进;我们的战略和商业计划的变化;我们获得充分融资以支持我们的战略计划和商业化努力以及我们能够继续作为"持续下去的企业"的能力;医学和研究机构获得资金以支持采用或继续使用我们的技术的能力;以及与我们的业务和财务状况有关的一般风险和不确定性,包括在我们的提交给证券交易委员会的申报文件中所述的风险和不确定性,包括但不限于,我们在2023年12月31日结束的年度报告(10-K表)以及我们随后向证券交易委员会提交的其他文件中所述的风险和不确定性。本新闻稿中包含的所有前瞻性声明仅在其发表之日有效,基于管理层的假设和估计。我们不承担任何公开更新任何前瞻性声明的义务,无论是因为收到新信息,还是因为未来事件的发生或其他原因。
CONTACTS
联系方式
Company Contact:
Erik Holmlin, CEO
Bionano Genomics, Inc.
+1 (858) 888-7610
eholmlin@bionano.com
公司联系人:
埃里克·霍尔姆林,首席执行官
bionano genomics,公司。
+1 (858) 888-7610
eholmlin@bionano.com
Investor Relations:
David Holmes
Gilmartin Group
+1 (858) 888-7625
IR@bionano.com
投资者关系:
大卫·霍姆斯
吉尔马汀集团
+1 (858) 888-7625
IR@bionano.com