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

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

T2 Biosystems | 8-K：T2 Biosystems宣佈T2Lyme商業啓動計劃、提供業務更新
美股sec公告 ·  03/20 21:22
牛牛AI助理已提取核心訊息
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，醫療診斷公司T2 Biosystems, Inc. 宣佈計劃在2024年第三季度將T2Lyme面板作爲實驗室開發測試（LDT）商業化。不需要T2Dx儀器的T2Lyme小組旨在向全國範圍內的美國參考實驗室提供萊姆病的早期結果。該公司目前正在與潛在的LDT合作伙伴進行討論。此外，T2 Biosystems還重點介紹了《臨床微生物學雜誌》上的一篇新出版物，該出版物展示了T2Resistance Panel的臨床益處，包括其高準確性和更快的檢測時間。該公司還聘請了BARDA前董事、前負責備災和應對的副助理部長羅賓遜博士擔任T2Biothreat小組商業化的戰略顧問。此外，T2 B...展開全部
2024年3月20日，醫療診斷公司T2 Biosystems, Inc. 宣佈計劃在2024年第三季度將T2Lyme面板作爲實驗室開發測試（LDT）商業化。不需要T2Dx儀器的T2Lyme小組旨在向全國範圍內的美國參考實驗室提供萊姆病的早期結果。該公司目前正在與潛在的LDT合作伙伴進行討論。此外，T2 Biosystems還重點介紹了《臨床微生物學雜誌》上的一篇新出版物，該出版物展示了T2Resistance Panel的臨床益處，包括其高準確性和更快的檢測時間。該公司還聘請了BARDA前董事、前負責備災和應對的副助理部長羅賓遜博士擔任T2Biothreat小組商業化的戰略顧問。此外，T2 Biosystems已獲得納斯達克聽證小組的延期，要求在2024年5月20日之前恢復遵守3500萬美元的上市證券市值要求。該公司重申了其2024年的財務前景，預計敗血症和相關產品總收入將在1,000萬美元至1,100萬美元之間，與去年相比將大幅增長。該公告是在發佈新聞稿和電話會議以討論這些更新的同時發佈的。

該公告為獨立文件：

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譯文內容由第三人軟體翻譯。


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