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. 2020 Sep 21:4:PO.20.00121.
doi: 10.1200/PO.20.00121. eCollection 2020.

Turnaround Time of Plasma Next-Generation Sequencing in Thoracic Oncology Patients: A Quality Improvement Analysis

Yi Lee  1 , Evan W Clark  1 , Marina S D Milan  1 , Christine Champagne  1 , Kesi S Michael  1 , Mark M Awad  1 , David A Barbie  1 , Michael L Cheng  1 , Kenneth L Kehl  1 , J Paul Marcoux  1 , Michael S Rabin  1 , Julia K Rotow  1 , Jacob M Sands  1 , Pasi A Jänne  1 , Geoffrey R Oxnard  1
Affiliations

Turnaround Time of Plasma Next-Generation Sequencing in Thoracic Oncology Patients: A Quality Improvement Analysis

Yi Lee et al. JCO Precis Oncol. .

Abstract

Purpose: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

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Conflict of interest statement

The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/po/author-center. Open Payments is a public database containing information reported by companies about payments made to US-licensed physicians (Open Payments). Mark M. AwadConsulting or Advisory Role: Genentech, Merck, Pfizer, Boehringer Ingelheim, AbbVie, AstraZeneca, MedImmune, Clovis Oncology, Nektar, Bristol Myers Squibb, ARIAD Pharmaceuticals, Foundation Medicine, Syndax, Novartis, Blueprint Medicines, Maverick Therapeutics, Achilles Therapeutics, Neon Therapeutics, Hengrui Therapeutics, Gritstone Oncology Research Funding: Genentech (Inst), Eli Lilly (Inst), AstraZeneca (Inst), Bristol Myers Squibb (Inst), Bristol-Myers SquibbDavid A. BarbieEmployment: NofOne Stock and Other Ownership Interests: NofOne, Xsphera Biosciences Honoraria: Merck, Gilead Sciences, Esai/H3 Biomedicine Consulting or Advisory Role: NofOne, Tango Therapeutics, Dantari Research Funding: Novartis, Bristol Myers Squibb, Gilead Sciences, Eli Lilly Patents, Royalties, Other Intellectual Property: Dana-Farber Cancer Institute patents on microfluidic culture and analysis of organotypic tumor spheroidsMichael L. ChengHonoraria: The Lynx Group, WebMD, Potomac Center for Medical Education Consulting or Advisory Role: AstraZeneca, Inivata Travel, Accommodations, Expenses: Daiichi Sankyo, Allergan, Sanofi, Natera, AstraZeneca, Guardant Health, WebMD, Potomac Center for Medical EducationKenneth L. KehlConsulting or Advisory Role: AetionMichael S. RabinStock and Other Ownership Interests: Acuity BioJulia K. RotowHonoraria: Takeda Consulting or Advisory Role: AstraZeneca Travel, Accommodations, Expenses: Array BioPharma, Eli LillyJacob M. SandsConsulting or Advisory Role: Genentech, Loxo, AstraZeneca, AbbVie, Guardant Health, Foundation Medicine, Medtronic, PharmaMar Travel, Accommodations, Expenses: AbbVie, Genentech, Incyte, AstraZenecaPasi A. JänneStock and Other Ownership Interests: Gatekeeper Pharmaceuticals, Loxo Consulting or Advisory Role: Pfizer, Boehringer Ingelheim, AstraZeneca, Merrimack Pharmaceuticals, Chugai Pharma, Genentech, Loxo, Mirati Therapeutics, Araxes Pharma, Ignyta, Eli Lilly, Takeda, Novartis, Biocartis, Voronoi, SFJ Pharmaceuticals Group, Sanofi, Daiichi Sankyo Research Funding: AstraZeneca, Astellas Pharma, Daiichi Sankyo, Eli Lilly, Boehringer Ingelheim, Puma Biotechnology, Takeda, Revolution Medicines Patents, Royalties, Other Intellectual Property: Co-inventor on a Dana-Farber Cancer Institute–owned patent on EGFR mutations licensed to Lab Corp and receive postmarketing royalties from this inventionGeoffrey R. OxnardEmployment: Foundation Medicine Honoraria: Sysmex, Guardant Health, Foundation Medicine Consulting or Advisory Role: AstraZeneca, Inivata, Takeda, Loxo, DropWorks, GRAIL, Janssen, Sysmex, Illumina, AbbVie, Merck Patents, Royalties, Other Intellectual Property: Dana-Farber Cancer Institute has a patent pending, titled “Non-invasive blood-based monitoring of genomic alterations in cancer,” on which I am a co-author (Inst) No other potential conflicts of interest were reported.

Figures

FIG 1.
FIG 1.
Measuring turnaround time (TAT) of plasma next-generation sequencing. (A) Clinical TAT 1 (TATC1) was defined as the interval between the date of patients’ samples being ordered and the date of result. Clinical TAT 2 (TATC2) was defined as the interval between the date of patients’ blood being drawn and the date of result. Clinical TAT 3 (TATC3) was defined as the interval between the date of the sample being shipped and the date of result. Laboratory TAT (TATL) was defined as the interval between the date of sample received by the laboratory and the date of result. (B) Over the time studied, clinical TAT (TATC2 median of 9 days) was slightly longer than laboratory TAT (TATL median of 7 days) given the additional time needed for specimen handling and shipment.
FIG 2.
FIG 2.
Monthly volume and turnaround time (TAT) over a 3-year period. (A) Volume of plasma next-generation sequencing orders have increased from August 2016 to October 2019. More recently, a greater number of cases have results returned within 7 days, whereas the majority have results returned within 14 days. (B) Median TATC2 (clinical TAT 2 defined as the interval between the date of patients’ blood being drawn and the date of result) each month initially dropped from 12 days in the first 6 months to 8 days in 2018, then increased to 9 days in the more recent 6 months.
FIG 3.
FIG 3.
Time of day when plasma next-generation sequencing results are received. Across 92 cases from the most recent 3-month period, the median time of result receipt was 4:01 pm Eastern Time (1:01 pm Pacific Time). Thirty-nine results (43%) were received after 5 pm Eastern Time on the day of receipt.
FIG 4.
FIG 4.
Two strategies for incorporating plasma next-generation sequencing (NGS) into initial treatment planning. (A) In a patient with a lower symptom burden, treatment could be scheduled to start 2 weeks from the blood draw, and plasma NGS results would usually be available by then (or earlier). (B) In a patient with a higher symptom burden, you may not be able to wait 2 weeks; empirical treatment may need to be scheduled within a week, at which point plasma NGS results may not yet be available, but these results could be incorporated in cycle 2 or later lines of therapy.
FIG A1.
FIG A1.
For the majority of cases (87%), the date of order and the date of blood draw were the same, whereas in a minority of cases (12%) the test was ordered in advance, ranging from 1 to 51 days.
FIG A2.
FIG A2.
For the majority of cases (87%), the date of blood draw and the date of shipment were the same, whereas for 13% of cases blood was shipped 1 to 5 days after being drawn.
FIG A3.
FIG A3.
Of cases, 75% took 1 day in transit (the date of shipment and the date of receipt). Median time was 1 day between the date of shipment and the date of receipt with the range being 1 to 5 days.
FIG A4.
FIG A4.
TATC1 (order to result turnaround time [TAT]) was noted to be skewed, with 15 cases (3%) having a TATC1 of more than 21 days, likely because of a planned delay between the order and the blood draw.
FIG A5.
FIG A5.
Date of blood draw and the date of shipment were often the same, TATC2 (blood draw to result [TAT]) and TATC3 (ship to result) had a similar distribution. TAT, turnaround time.
FIG A6.
FIG A6.
Time from blood draw to shipment. Over the time studied, it consistently took a median of 0 days from blood draw to specimen shipment, meaning the patients’ samples were shipped on the same day.
FIG A7.
FIG A7.
Time from shipment to receipt of the specimen at the laboratory. In-transit time was consistently a median of 1 day over the period studied.
See this image and copyright information in PMC

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