Lee Yi, Clark Evan W, Milan Marina S D, Champagne Christine, Michael Kesi S, Awad Mark M, Barbie David A, Cheng Michael L, Kehl Kenneth L, Marcoux J Paul, Rabin Michael S, Rotow Julia K, Sands Jacob M, Jänne Pasi A, Oxnard Geoffrey R
Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute, Boston, MA.
JCO Precis Oncol. 2020 Sep 21;4. doi: 10.1200/PO.20.00121. eCollection 2020.
Genomic analysis of plasma cell-free DNA has become a widespread tool for advanced non-small-cell lung cancer care. Whereas accuracy has been reported on widely, its usefulness is also tied tightly to its turnaround time (TAT), which is not well studied.
We studied the TAT of commercial plasma next-generation sequencing (NGS; Guardant360) for 533 results from 461 patients at our center between August 2016 and October 2019. The study received institutional review board approval as a quality improvement study; therefore, the results of the test and clinical setting were not analyzed.
TAT from blood draw to result (median of 9 days) was slightly longer than the TAT from laboratory receipt to result, a median of 7 days. Testing volume at our center increased three-fold over the time of the study. During this period, clinical TAT decreased from an initial median of 12 days to a median of 8 days in 2018, but more recently the median increased slightly to 9 days. During the most recent 12 months, 231 (95%) of 247 cases resulted within 14 days from blood draw, with delayed results usually because of billing, whereas 44 cases (18%) resulted within 7 days of blood draw. Studying 92 cases drawn in the most recent 3-month period, the median time of result receipt was 4:01 pm Eastern Time/1:01 pm Pacific Time; 39 results (43%) were returned after 5:00 pm Eastern Time.
In a large single-institution experience, we find that plasma NGS results can routinely be expected within 2 weeks, but uncommonly result within 1 week, supporting the need for new strategies to incorporate plasma NGS into the initial genotyping of advanced non-small-cell lung cancer.
血浆游离DNA的基因组分析已成为晚期非小细胞肺癌治疗中广泛应用的工具。虽然其准确性已有广泛报道，但其实用性也用用性也与周转时间（TAT）紧密相关，而这方面的研究尚不充分。
我们研究了2016年8月至2019年10月期间，我院461例患者533份商业血浆下一代测序（NGS；Guardant360）结果的周转时间。该研究作为一项质量改进研究获得了机构审查委员会的批准；因此，未对检测结果和临床情况进行分析。
从采血到出结果的周转时间（中位数为9天）略长于从实验室收到样本到出结果的周转时间，后者中位数为7天。在研究期间，我院的检测量增加了两倍。在此期间，临床周转时间从最初的中位数12天降至2018年的中位数8天，但最近中位数略有增加至9天。在最近的12个月中，247例中的231例（95%）在采血后14天内出结果，结果延迟通常是因为计费问题，而44例（18%）在采血后7天内出结果。研究最近3个月内采集的92例样本，结果接收的中位时间为东部时间下午4:01/太平洋时间下午1:01；39份结果（43%）在东部时间下午5:00之后返回。
在一项大型单机构研究中，我们发现血浆NGS结果通常可在2周内获得，但很少能在1周内获得，这支持了需要新策略将血浆NGS纳入晚期非小细胞肺癌初始基因分型的必要性。
