NEW YORK – Quest Diagnostics said on Monday the US Food and Drug Administration has granted breakthrough device designation for the firm's Haystack minimal residual disease (MRD) test.

纽约——Quest Diagnostics 周一表示，美国食品和药物管理局 (FDA) 已授予该公司 Haystack 微小残留病 (MRD) 检测“突破性设备”称号。

The tumor-informed, whole-exome sequencing assay

肿瘤知情的全外显子组测序分析

detects circulating tumor DNA in blood to

检测血液中的循环肿瘤DNA以

identify MRD-positive patients with stage II colorectal cancer who have received curative-intent surgical treatment and may benefit from adjuvant therapy. Quest acquired the test

识别接受治愈性手术治疗的II期结直肠癌MRD阳性患者，这些患者可能受益于辅助治疗。Quest收购了该测试。

when

当

it

它

bought

购买

Haystack Oncology in 2023.

2023年的干草堆肿瘤学。

Quest said it launched a laboratory-developed test version of the test in 2024, broadening access to the technology for oncologists and pharmaceutical partners.

Quest表示，公司在2024年推出了一项实验室开发的测试版本，扩大了肿瘤学家和制药合作伙伴使用该技术的机会。

The FDA provides breakthrough device designation to devices and diagnostics that it deems effective for treating or diagnosing diseases and medical conditions. The designation provides the public access to such products and accelerates the development, assessment, and regulatory review of them by the FDA, Quest said.

FDA 为那些它认为可有效治疗或诊断疾病和医疗状况的设备和诊断工具提供突破性设备认定。Quest 表示，该认定使公众可以获取此类产品，并加快 FDA 对它们的开发、评估和监管审查。

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