Performance of the Oncomine^TM Lung cfDNA Assay for Liquid Biopsy by NGS of NSCLC Patients in Routine Laboratory Practice

Round 1

Reviewer 1 Report

Beside the use of the reference DNA with serial dilutions of allele frequencies, it would have been also interesting to check a serial dilution of input amounts with defined reference DNA. This could help to gain information concerning the relation of input amounts and mutation detection. A statement on that is difficult when only using patient material because the real amount of ctDNA in the cfDNA is, as the authors mention, unclear.

Furthermore, repeated determination to determine the reproducibility or a comparison to another assay would have been of interest.

Author Response

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Reviewer 2 Report

The authors described the performance of the OLcfA quite well in the aspect of technology and the clinical aspect. And It would have been better to compare the tumor results. 

Author Response

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Reviewer 3 Report

This study highlights the use of cfDNA in lung cancer using an NGS approach with molecular barcodes - an important study in the field of liquid biopsy. 

Figure 1 - this has been screenshot and contains the error markings in red underneath - please correct.

3.2  - the plasma concentration range of 2.6ng/ml is below the minimum input of 20ng needed by the NGS platform? How have the authors addressed this? line 153 - 1ng but line 93 shows 20ng minimum?? which is it?

How has the data been validated? Has another approach been used?

line 355-359 - I think this speaks more to assay sensitivity and given that most samples were under the minimum input - what are the authors concerns here?

Author Response

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Round 2

Reviewer 3 Report

The authors have now addressed my comments/concerns.

Author Response

We thank the Reviewer for suggestions.