References

Home

1. Frampton GM et al. Nat Biotechnol 2013; 31: 1023-1031.

2. FoundationOne®CDx Technical Specifications, 2018. Available at: www.rochefoundationmedicine.com/f1cdxtech
(Accessed August 2020).

3. FoundationOne®CDx FDA Approval, 2017. Available at:
https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170019a.pdf (Accessed August 2020).

4. Clark TA et al. J Mol Diagn 2018; 20: 686-702.

5. Data on file: FoundationOne Liquid CDx Technical Specifications, 2020. Available at: www.eifu.online/FMI/190070862 (Accessed August 2020).

6. Data on file: Clinical and analytical validation data file for FoundationOne Liquid CDx. 

7. FoundationOne®Heme Technical Specifications, 2017. Available at: www.foundationmedicine.com/genomic-testing/foundation-one-heme (Accessed August 2020).

8. He J et al. Blood 2016; 127: 3004-3014.

9. Roche Media Release, 2018. Available at: www.roche.com/media/releases/med-cor-2018-06-19.html (Accessed August 2020).

10. Drilon A et al. Clin Cancer Res 2015; 21: 3631–3639.

11. Rankin A et al. Oncologist 2016; 21: 1306–1314.

12. Ross JS et al. Cancer 2016; 122: 2654–2662.

13. Suh JH et al. Oncologist 2016; 21: 684–691.

14. Hirshfield KM et al. Oncologist 2016; 21: 1315–1325.

15. FoundationOne®CDx Sample Report. Available at: www.foundationmedicine.nl/content/dam/rfm/sample-reports/f1cdx/eu_version_-_ema_without_page_1/F1CDx%20EU%20Sample%20Report%20(Lung).pdf (Accessed
August 2020).

 

What We Do

1. Frampton GM et al. Nat Biotechnol 2013; 31: 1023–1031.

2. FoundationOne®CDx Technical Specifications, 2018.
Available at: www.rochefoundationmedicine.com/f1cdxtech (Accessed August 2020).

3. Clark TA et al. J Mol Diagn 2018; 20: 686–702.

4. Data on file: FoundationOne Liquid CDx Technical Specifications, 2020 Available at: www.eifu.online/FMI/190070862 (Accessed August 2020).  

5. Data on file: Clinical and analytical validation data file for FoundationOne Liquid CDx.

6. FoundationOne®Heme Technical Specifications, 2017.
Available at: www.foundationmedicine.com/genomic-testing/foundation-one-heme  (Accessed August 2020).

7. He J et al. Blood 2016; 127: 3004–3014.

8. FoundationOne Liquid CDx FDA Approval, 2020.
Available at: www.foundationmedicine.com/press-releases/445c1f9e-6cbb-488b-84ad-5f133612b721 (Accessed August 2020).

9. Drilon A et al. Clin Cancer Res 2015; 21: 3631–3639.

10. Rankin A et al. Oncologist 2016; 21: 1306–1314.

11. Ross JS et al. Cancer 2016; 122: 2654–2662.

12. Suh JH et al. Oncologist 2016; 21: 684–691.

13. Hirshfield KM et al. Oncologist 2016; 21: 1315–1325.

14. Chalmers ZR et al. Genome Med 2017; 9: 34.

15. Rozenblum AB et al. J Thorac Oncol 2017; 12: 258–268.

16. Schrock AB et al. Clin Cancer Res 2016; 22: 3281–3285.

17. Ross JS et al. Gynecol Oncol 2013; 130: 554–559.

18. Hall MJ et al. J Clin Oncol 2016; 34: 1523–1523.

19. Kok M et al. ESMO Open 2019; 4(Suppl 2): e000511.

20. Zhao P et al. J Hematol Oncol 2019; 12: 54.

21. Abida W et al. JAMA Oncol 2019; 5: 471–478.

22. NCCN Clinical Practice Guidelines in Oncology. Prostate Cancer. Version 2.2020, May 2020. Available at: www.nccn.org/professionals/physician_gls/pdf/prostate.pdf (Accessed August 2020).

23.   FDA approves pembrolizumab for first-line treatment of MSI-H/dMMR colorectal cancer.
Available at: www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-pembrolizumab-first-line-treatment-msi-hdmmr-colorectal-cancer (Accessed August 2020).

24. Gandara DR et al. Nat Med 2018; 24: 1441–1448.

25. FDA approves pembrolizumab for adults and children with TMB-H solid tumors, 2020.
Available at: www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-pembrolizumab-adults-and-children-tmb-h-solid-tumors (Accessed August 2020).

26. Marabelle A et al. Ann Oncol 2019; 30(Suppl 5): v475-v532.

27. Yarchoan M et al. JCI Insight 2019; 4: e126908.

28. Khagi Y et al. Clin Cancer Res 2017; 23: 5729–5736.

29. Socinski M. Ann Oncol 2019; 30(Suppl 5): v851–v934.

30. FoundationOne®CDx Sample Report.
Available  at: www.foundationmedicine.nl/content/dam/rfm/sample-reports/f1cdx/eu_version_-_ema_without_page_1/F1CDx%20EU%20Sample%20Report%20(Lung).pdf (Accessed August 2020).

31. Data on file: FoundationOne Liquid CDx mock report, 2020.

32. A search for "Foundation Medicine"[Affiliation] on the NCBI database resulted in 518 publications, as of August 2020. Available at: www.ncbi.nlm.nih.gov/pubmed/?term=%22Foundation+Medicine%22%5BAffiliation%5D (Accessed August 2020).

33. Foundation Medicine Publications.
Available at:www.foundationmedicine.com/publications (Accessed August 2020).

34.   Foundation Insights.
Available at:www.foundationmedicine.com/insights-and-trials/foundation-insights (Accessed August 2020).

Our Services

1. Frampton GM et al. Nat Biotechnol 2013; 31: 1023–1031.

2. FoundationOne®CDx Technical Specifications, 2018. Available at: www.rochefoundationmedicine.com/f1cdxtech (Accessed August 2020).

3. FoundationOne®CDx FDA Approval, 2017. Available at: 
 https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170019a.pdf (Accessed August 2020).

4. Data on file: FoundationOne Liquid CDx Technical Specifications, 2020 Available at: www.eifu.online/FMI/190070862 (Accessed August 2020).

5. Data on file: Clinical and analytical validation data file for FoundationOne Liquid CDx.

6. FoundationOne Liquid CDx FDA Approval, 2020. Available at: www.foundationmedicine.com/press-releases/445c1f9e-6cbb-488b-84ad-5f133612b721 (Accessed August 2020).

7. FoundationOne®Heme Technical Specifications, 2017.
Available at: www.foundationmedicine.com/genomic-testing/foundation-one-heme (Accessed August 2020).

8. He J et al. Blood 2016; 127: 3004–3014.

FoundationOne®CDx

1. Frampton GM et al. Nat Biotechnol 2013; 31: 1023–1031.

2. FoundationOne®CDx Technical Specifications 2018. Available at: www.rochefoundationmedicine.com/f1cdxtech  (Accessed August 2020).

3. FoundationOne®CDx FDA Approval, 2017. Available at: 
https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170019a.pdf (Accessed August 2020).

4. FoundationOne®CDx clinical validation, 2017. Available at: http://www.foundationmedicine.com/genomic-testing/foundation-one-cdx  (Accessed August 2020).

5. FoundationOne®CDx Sample Report. Available at: https://www.foundationmedicine.nl/content/dam/rfm/sample-reports/f1cdx/eu_version_-_ema_without_page_1/F1CDx%20EU%20Sample%20Report%20(Lung).pdf  (Accessed August 2020).

6. Drilon A et al. Clin Cancer Res 2015; 21: 3631–3639.

7. Rankin A et al. Oncologist 2016; 21: 1306–1314.

8. Ross JS et al. Cancer 2016; 122: 2654–2662.

9. Suh JH et al. Oncologist 2016; 21: 684–691.

10. Hirshfield KM et al. Oncologist 2016; 21: 1315–1325.

11. Rozenblum AB et al. J Thorac Oncol 2017; 12: 258–268.

12. Schwaederle M et al. Mol Cancer Ther 2016; 15: 743–752.

13. Wheler JJ et al. Cancer Res 2016; 76: 3690–3701.

14. Dhir M et al. Cancer Med 2017; 6: 195–206.

15. Zhao P et al. J Hematol Oncol 2019; 12: 54.

16. Abida W et al. JAMA Oncol 2019; 5: 471–478

17. FDA approves pembrolizumab for first-line treatment of MSI-H/dMMR colorectal cancer. Available at: www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-pembrolizumab-first-line-treatment-msi-hdmmr-colorectal-cancer (Accessed August 2020).

18. NCCN Clinical Practice Guidelines in Oncology. Prostate Cancer. Version 2.2020, May 2020. Available at: www.nccn.org/professionals/physician_gls/pdf/prostate.pdf (Accessed August 2020).

19. Kok M et al. ESMO Open 2019; 4(Suppl 2): e000511. 

20. Gandara DR et al. Nat Med 2018; 24: 1441–1448.

21. FDA approves pembrolizumab for adults and children with TMB-H solid tumors, 2020. Available at: https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-pembrolizumab-adults-and-children-tmb-h-solid-tumors (Accessed August 2020).

22. Marabelle A et al. Ann Oncol 2019; 30(Suppl 5): v475-v532.

23. Yarchoan M et al. JCI Insight 2019; 4: e126908.

24. Swisher EM et al. Lancet Oncol 2017; 18:75−87.

25. Coleman RL et al. Lancet 2017; 390:1949−61.

26. Merker JD et al. J Clin Oncol 2018; 36: 1631–1641.

27. Scheerens H et al. Clin Transl Sci 2017; 10: 84–92.

28. NCCN Clinical Practice Guidelines in Oncology. Non-Small Cell Lung Cancer. Version 6.2020, June 2020. Available at: https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf (Accessed August 2020).

29. Schrock AB et al. Clin Cancer Res 2016; 22: 3281–3285.

30. Ali SM et al. Oncologist 2016; 6: 762–770.

31. Pekar-Zlotin M et al. Oncologist 2015; 20: 316–322

32. Data on file: FoundationOne Liquid CDx Technical Specifications, 2020 Available at: www.eifu.online/FMI/190070862 (Accessed August 2020).

33. Data on file: Clinical and analytical validation data file for FoundationOne Liquid CDx.

FoundationOne®Liquid CDx

1. Data on file: FoundationOne Liquid CDx Technical Specifications, 2020 Available at: www.eifu.online/FMI/190070862 (Accessed August 2020).

2. Data on file: Clinical and analytical validation data file for FoundationOne Liquid CDx.

3. FoundationOne Liquid CDx FDA Approval, 2020. Available at: https://www.foundationmedicine.com/press-releases/445c1f9e-6cbb-488b-84ad-5f133612b721  (Accessed August 2020).

4. Planchard D et al. Ann Oncol 2019; 30: 863–870.

5. NCCN Clinical Practice Guidelines in Oncology. Non-Small Cell Lung Cancer. Version 6.2020, June 2020. Available at: https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf (Accessed August 2020).

6. Cardoso F et al. Ann Oncol 2019; 30: 1674.

7. NCCN Clinical Practice Guidelines in Oncology. Breast Cancer. Version 5.2020, July 2020. Available at: https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf (Accessed August 2020).

8. NCCN Clinical Practice Guidelines in Oncology. Prostate Cancer. Version 2.2020, May 2020. Available at: https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf (Accessed August 2020).

9. NCCN Clinical Practice Guidelines in Oncology. Ovarian Cancer. Version 1.2020, March 2020. https://www.nccn.org/professionals/physician_gls/pdf/ovarian.pdf (Accessed August 2020).

10. Colombo N et al. Ann Oncol 2019; 30: 672–705.

11. Parker C et al. Ann Oncol 2020; 31: 1119–1134.

12. Lebel S et al. J Psychosom Res 2003; 55: 437–443.

13. Hayes Balmadrid MA et al. J Health Psychol 2017; 22: 561–571.

14. Francis G, Stein S. Int J Mol Sci 2015; 16: 14122–14142.

15. Siravegna G et al. Ann Oncol 2019; 30: 1580–1590.

16. Data on file: FoundationOne Liquid CDx Specimen instructions.

17. FoundationOne CDx FDA Approval, 2017. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170019a.pdf (Accessed August 2020).

18. FoundationOne CDx Technical Specifications, 2018. Available at: www.rochefoundationmedicine.com/f1cdxtech (Accessed August 2020).

19. Kok M et al. ESMO Open 2019; 4(Suppl 2): e000511.

20. Zhao P et al. J Hematol Oncol 2019; 12: 54.

21. Abida W et al. JAMA Oncol 2019; 5: 471–478.

22. Mateo J et al. Eur Urol 2017; 71: 417–425.

23. Gandara DR et al. Nat Med 2018; 24: 1441–1448.

24. Socinski M. Ann Oncol 2019; 30(Suppl 5): v851–v934.

25. Khagi Y et al. Clin Cancer Res 2017; 23: 5729–5736.

26. FDA approves pembrolizumab for adults and children with TMB-H solid tumors, 2020.
Available at: https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-pembrolizumab-adults-and-children-tmb-h-solid-tumors (Accessed August 2020).

27. Marabelle A et al. Ann Oncol 2019; 30(Suppl 5): v475-v532.

28. Data on file: FoundationOne Liquid CDx Specimen instructions.

29. Arnaud A. Value in Health 2016. 19:PCN57.

30. Gadgeel SM et al. Ann Oncol 2019; 30: S5; v851–v934; presented at ESMO 2019.

31. Merker JD et al. J Clin Oncol 2018; 36: 1631–1641.

32. Scheerens H et al. Clin Transl Sci 2017; 10: 84–92.

33. Conway AM et al. Br J Cancer 2019; 120: 141–153.

34. Amatu A et al. ESMO Open 2016; 1: e000023.

35. Pikor LA et al. Lung Cancer 2013; 82: 179–189.

36. Tsao AS et al. J Thorac Oncol 2016; 11: 613–638.

37. Sanchez-Vega F et al. Cell 2018; 173: 321–37.e10.

38. Kroeger PT Jr. et al. Curr Opin Obstet Gynecol 2017; 29: 26–34.

39. Roche media Release, BFAST, 30 September 2019. Available at: https://www.roche.com/media/releases/med-cor-2019-09-30c.htm (Accessed August 2020).

40. Dearden S et al. Ann Oncol 2013; 24: 2371–2376.

41. Data on file: FoundationOne Liquid CDx mock report, 2020

42. FoundationOne®CDx Sample Report. Available at: https://www.foundationmedicine.nl/content/dam/rfm/sample-reports/f1cdx/eu_version_-_ema_without_page_1/F1CDx%20EU%20Sample%20Report%20(Lung).pdf (Accessed August 2020).

43. FoundationOne CDx Technical Specifications, 2018. Available at: www.rochefoundationmedicine.com/f1cdxtech (Accessed August 2020).

FoundationOne®Heme

1. FoundationOne®Heme Technical Specifications, 2019. Available at:
 www.foundationmedicine.com/genomic-testing/foundation-one-heme (Accessed August 2020).

2. He J et alBlood 2016; 127: 3004–3014.

3. Gounder M et al. Presented at ASCO Annual Meeting 2017, Chicago (Illinois), USA: Abstract #11001 and oral presentation.

4. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Acute Lymphoblastic Leukaemia. V.1.2018, 2018. Available at:
 https://www.nccn.org/professionals/physician_gls/default.aspx (Accessed August 2020).

5. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Acute Myeloid Leukaemia. V.1.2019, 2019. Available at:
https://www.nccn.org/professionals/physician_gls/default.aspx (Accessed August 2020).

6. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Myelodysplastic Syndromes. V.2.2019, 2018. Available at:
 https://www.nccn.org/professionals/physician_gls/default.aspx (Accessed August 2020).

7. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Multiple Myeloma. V.2.2019, 2018. Available at: 
https://www.nccn.org/professionals/physician_gls/default.aspx (Accessed August 2020).

8. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). B-cell Lymphoma. V.1.2019, 2018. Available at:
 https://www.nccn.org/professionals/physician_gls/default.aspx (Accessed August 2020).

9. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). T-cell Lymphoma. V.2.2019, 2018. Available at: 
https://www.nccn.org/professionals/physician_gls/default.aspx (Accessed August 2020).

10. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Myeloproliferative Neoplasms. V.2.2019, 2018. Available at: 
https://www.nccn.org/professionals/physician_gls/default.aspx (Accessed August 2020).

11. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Chronic Lymphocytic Leukaemia. V.5.2019, 2018. Available at: 
https://www.nccn.org/professionals/physician_gls/default.aspx (Accessed August 2020).

12. Morley S et alBlood 2015; 126: 3898.

13. Kobos R et al. Presented at ASH Annual Meeting 2016, San Diego (California), USA: Abstract 1605.

14. He J et al. Presented at ASH Annual Meeting 2015, Orlando (Florida), USA: Abstract 2651.

15. Galanina N et al. Cancers (Basel) 2018; 11.pii: E11.

16. Goodman AM et al. JCO Precis Oncol 2017. doi: 10.1200/PO.16.00004. 

17. Heuck C et al. Blood 2015; 126: 369.

18. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Soft Tissue Sarcoma. V.2.2019, 2019. Available at: 
https://www.nccn.org/professionals/physician_gls/recently_updated.aspx (Accessed August 2020).

19. Groisberg R et al. Oncotarget 2017; 8: 39254–39267.

20. Doyle LA et al. Cancer 2014; 120: 1763–1774.

21. Cote GM et al. Oncologist 2018; 23: 234–242.

22. Chmielecki J et al. Cancer Res 2017; 77: 509–519.

23. Data on file: FoundationOne®Heme Sample Report. 2018.

24. Chavan SS et al. Blood Cancer J 2017; 7: e535.

25. Severson EA et al. Presented at ASH Annual Meeting 2017, Atlanta (Georgia), USA: Abstract 476.

26. Bustoros M et al. Am Soc Clin Oncol Educ Book 2017; 37: 548–560.

27. Bolen J et al. Blood 2017; 130: 2729.

28. Grzegorz S et al. Blood 2007; 110: 2067.

29. Rossi D et al. Clin Cancer Res 2009; 15: 995–1004.

30. Zenz T et al. J Clin Oncol 2010; 28: 4473–4479.

31. Woyach JA et al. J Clin Oncol 2017; 35: 1437–1443.

32. VITRAKVI® (larotrectinib) Prescribing Information. Available at:
 https://www.loxooncology.com/docs/general/vitrakvi.pdf (Accessed August 2020).

33. Vaishnavi A et al. Cancer Discov 2015; 5: 25–34.

34. GLEEVEC® (imatinib mesylate) Prescribing Information. Available at: 
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021588s024lbl.pdf (Accessed August 2020).

35. Tarlock K et al. Oncotarget 2018; 9: 26417–26430.

36. Severson EA et al. Oncologist 2019; 24: 372–374.

37. Chmielecki J et al. Cancer Res 2017; 77: 509–519.

38. Pavlick D et al. Pediatr Blood Cancer 2017; 64: e26433.

39. FoundationOne®Heme Specimen Instructions, 2018. Available at: 
https://assets.ctfassets.net/vhribv12lmne/36S2Vq3BPqwaTLoww8gerj/78a3f27012a3b3ea9e3064561dc22a02/F1H_Specimen_Instructions.pdf (Accessed August 2020).

About Us

1. Roche Media Release, 2018. Available at:
https://www.roche.com/media/releases/med-cor-2018-06-19.htm (Accessed August 2020).

2. Foundation Insights. Available at:
https://www.foundationmedicine.com/insights-and-trials/foundation-insights. (Accessed August 2020).

3. A search for “Foundation Medicine”[Affiliation] on the NCBI database resulted in 518 publications, as of August 2020. Available at:
https://www.ncbi.nlm.nih.gov/pubmed/?term=%E2%80%9CFoundation+Medicine%E2%80%9D%5BAffiliation%5D (Accessed August 2020).

Frequently asked questions

1. Ginsburg GS et al. Health Aff (Millwood) 2018; 37: 694–701.

2. Nesline MK et al. Oncotarget 2019; 10: 4616–4629.

3. van der Velden DL et al. Nature 2019 [Epub ahead of print].

4. Hainsworth JD et al. J Clin Oncol 2018; 36: 536–542.

5. Reitsma M et al. J Manag Care Spec Pharm 2019; 25: 601–611.

6. Signorovitch J et al. J Clin Oncol 2017; 35 (Suppl 15): 6599–6599.

7. Conway J, Marino I. Am J Manag Care 2016; 22 (Suppl 12): SP439–SP443.

8. Frampton GM et al. Nat Biotechnol 2013; 31: 1023–1031.

9. FoundationOne®CDx Technical Specifications, 2018. Available at: www.rochefoundationmedicine.com/f1cdxtech (Accessed August 2020).

10. Data on file: FoundationOne Liquid CDx Technical Specifications, 2020 Available at: www.eifu.online/FMI/190070862 (Accessed August 2020).

11. FoundationOne®Heme Technical Specifications, 2019. Available at: www.foundationmedicine.com/genomic-testing/foundation-one-heme (Accessed August 2020).

12. He J et al. Blood 2016; 127: 3004–3014.