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

SEC announcement ·  Mar 20 21:22
Summary by Futu AI
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.

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