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T2 Biosystems | 8-K: T2 Biosystems Announces T2Lyme Commercial Launch Plan, Provides Business Update

T2 Biosystems | 8-K: Current report

T2 Biosystems | 8-K:重大事件
美股sec公告 ·  03/20 09:22
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On March 20, 2024, T2 Biosystems, Inc., a medical diagnostics company, announced its plans to commercialize the T2Lyme Panel as a laboratory developed test (LDT) in the third quarter of 2024. The T2Lyme Panel, which does not require the T2Dx Instrument, aims to provide early Lyme disease results to U.S. reference laboratories nationwide. The company is currently in discussions with potential LDT partners. Additionally, T2 Biosystems highlighted a new publication in the Journal of Clinical Microbiology that demonstrates the clinical benefits of the T2Resistance Panel, including its high accuracy and faster detection times. The company has also engaged Dr. Robin Robinson, former Director of BARDA and former Deputy Assistant Secretary for Preparedness and Response, as a strategic advisor for the commercialization of the T2Biothreat Panel. Furthermore, T2 Biosystems has received...Show More
On March 20, 2024, T2 Biosystems, Inc., a medical diagnostics company, announced its plans to commercialize the T2Lyme Panel as a laboratory developed test (LDT) in the third quarter of 2024. The T2Lyme Panel, which does not require the T2Dx Instrument, aims to provide early Lyme disease results to U.S. reference laboratories nationwide. The company is currently in discussions with potential LDT partners. Additionally, T2 Biosystems highlighted a new publication in the Journal of Clinical Microbiology that demonstrates the clinical benefits of the T2Resistance Panel, including its high accuracy and faster detection times. The company has also engaged Dr. Robin Robinson, former Director of BARDA and former Deputy Assistant Secretary for Preparedness and Response, as a strategic advisor for the commercialization of the T2Biothreat Panel. Furthermore, T2 Biosystems has received an extension from the Nasdaq Hearings Panel to regain compliance with the $35 million Market Value of Listed Securities requirement by May 20, 2024. The company reiterated its financial outlook for 2024, expecting total sepsis and related product revenue to be between $10.0 million and $11.0 million, which would represent a significant growth compared to the previous year. The announcement was made alongside the release of a press release and a conference call to discuss these updates.
2024年3月20日,医疗诊断公司T2 Biosystems, Inc. 宣布计划在2024年第三季度将T2Lyme面板作为实验室开发测试(LDT)商业化。不需要T2Dx仪器的T2Lyme小组旨在向全国范围内的美国参考实验室提供莱姆病的早期结果。该公司目前正在与潜在的LDT合作伙伴进行讨论。此外,T2 Biosystems还重点介绍了《临床微生物学杂志》上的一篇新出版物,该出版物展示了T2Resistance Panel的临床益处,包括其高准确性和更快的检测时间。该公司还聘请了BARDA前董事、前负责备灾和应对的副助理部长罗宾逊博士担任T2Biothreat小组商业化的战略顾问。此外,T2 B...展开全部
2024年3月20日,医疗诊断公司T2 Biosystems, Inc. 宣布计划在2024年第三季度将T2Lyme面板作为实验室开发测试(LDT)商业化。不需要T2Dx仪器的T2Lyme小组旨在向全国范围内的美国参考实验室提供莱姆病的早期结果。该公司目前正在与潜在的LDT合作伙伴进行讨论。此外,T2 Biosystems还重点介绍了《临床微生物学杂志》上的一篇新出版物,该出版物展示了T2Resistance Panel的临床益处,包括其高准确性和更快的检测时间。该公司还聘请了BARDA前董事、前负责备灾和应对的副助理部长罗宾逊博士担任T2Biothreat小组商业化的战略顾问。此外,T2 Biosystems已获得纳斯达克听证小组的延期,要求在2024年5月20日之前恢复遵守3500万美元的上市证券市值要求。该公司重申了其2024年的财务前景,预计败血症和相关产品总收入将在1,000万美元至1,100万美元之间,与去年相比将大幅增长。该公告是在发布新闻稿和电话会议以讨论这些更新的同时发布的。
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