share_log

T2 Biosystems | 8-K: T2 Biosystems Announces Update on New Product Development Pipeline

T2 Biosystems | 8-K: T2 Biosystems Announces Update on New Product Development Pipeline

T2 Biosystems | 8-K：T2 Biosystems公布新产品开发管线的最新进展
美股SEC公告 ·  2024/09/09 21:10

Moomoo AI 已提取核心信息

T2 Biosystems announced plans to launch multiple direct-from-blood diagnostic tests over the next 15 months. The company is finalizing a 510(k) application for the T2Resistance Panel for Q4 2024 FDA submission, while its T2Candida Panel expansion for pediatric use awaits FDA clearance. The T2Bacteria Panel's pediatric application is advancing through internal validation.The company revised its T2Lyme Panel commercialization strategy, opting to build or acquire its own laboratory rather than pursue partnership launches. This strategic shift may delay the planned Q3 2024 launch but is expected to yield higher profit margins and greater business control. The test aims to detect Lyme disease within 30 days post-infection, significantly faster than current 30-60 day antibody tests.Additionally, T2 Biosystems is seeking non-dilutive funding to complete development of a Candida auris diagnostic test, following successful early development with the CDC. Three pipeline products have received FDA Breakthrough Device designation, including the T2Resistance Panel, T2Lyme Panel, and Candida auris test, potentially expediting their review process.
T2 Biosystems announced plans to launch multiple direct-from-blood diagnostic tests over the next 15 months. The company is finalizing a 510(k) application for the T2Resistance Panel for Q4 2024 FDA submission, while its T2Candida Panel expansion for pediatric use awaits FDA clearance. The T2Bacteria Panel's pediatric application is advancing through internal validation.The company revised its T2Lyme Panel commercialization strategy, opting to build or acquire its own laboratory rather than pursue partnership launches. This strategic shift may delay the planned Q3 2024 launch but is expected to yield higher profit margins and greater business control. The test aims to detect Lyme disease within 30 days post-infection, significantly faster than current 30-60 day antibody tests.Additionally, T2 Biosystems is seeking non-dilutive funding to complete development of a Candida auris diagnostic test, following successful early development with the CDC. Three pipeline products have received FDA Breakthrough Device designation, including the T2Resistance Panel, T2Lyme Panel, and Candida auris test, potentially expediting their review process.
T2 Biosystems 宣布计划在接下来的 15 个月内推出多种直接从血液诊断测试。该公司正在为 T2Resistance Panel 的 510(k) 申请进行最终定稿，计划于 2024 年第四季度向 FDA 提交，而其 T2Candida Panel 的儿童使用扩展正在等待 FDA 的批准。T2Bacteria Panel 的儿童应用正在通过内部验证进行推进。该公司修订了 T2Lyme Panel 的商业化策略，选择建立或收购自己的实验室，而不是追求合作发布。这一策略转变可能会推迟计划于 2024 年第三季度的发布，但预计将带来更高的利润率和更大的业务控制。该测试旨在在感染后 30 天...展开全部
T2 Biosystems 宣布计划在接下来的 15 个月内推出多种直接从血液诊断测试。该公司正在为 T2Resistance Panel 的 510(k) 申请进行最终定稿，计划于 2024 年第四季度向 FDA 提交，而其 T2Candida Panel 的儿童使用扩展正在等待 FDA 的批准。T2Bacteria Panel 的儿童应用正在通过内部验证进行推进。该公司修订了 T2Lyme Panel 的商业化策略，选择建立或收购自己的实验室，而不是追求合作发布。这一策略转变可能会推迟计划于 2024 年第三季度的发布，但预计将带来更高的利润率和更大的业务控制。该测试旨在在感染后 30 天内检测莱姆病，显著快于当前的 30-60 天抗体测试。此外，T2 Biosystems 正在寻求非稀释资金，以完成针对 Candida auris 诊断测试的开发，在与 CDC 成功开展早期开发之后。三款管道产品已获得 FDA 突破设备认证，包括 T2Resistance Panel、T2Lyme Panel 和 Candida auris 测试，这可能加速其审查流程。

该公告为独立文件：

独立文件1  查看翻译

独立文件2  查看翻译

声明：本内容仅用作提供资讯及教育之目的，不构成对任何特定投资或投资策略的推荐或认可。 更多信息
    相关股票 相关股票
    代码 迷你走势 最新价
    特斯拉
    TSLA
    -- 355.840
    英伟达
    NVDA
    -- 138.850
    阿里巴巴
    BABA
    -- 124.730
    英特尔
    INTC
    -- 23.600
    Tempus AI
    TEM
    -- 89.440
    解锁完整榜单
    重估中国资产
    继中国开创性的DeepSeek技术推出之后， 华尔街大行重估对中国市场的投资前景。
    热门讨论
    科技巨头财报季如火如荼，英伟达压轴会表现如何？
    星期四， $亚马逊 (AMZN.US)$ 股价在公司报告第四季度调整后每股收益为1.86美元，预估为每股1.50美元，营业收入为1877.9亿，预估为1873.2亿后下跌。该公司预测第一季度的营业收入数字低于华尔街的预期，预测本季度最多为1550亿，而分析师希望为1580亿。 星 展开
    亚马逊盈利预告：猜测开盘价，获取奖励！