Nova BioLabs

Nova is developing a truly personalized cancer recurrence test that allows us to focus surveillance on an individual’s tumor abnormalities, instead of the “catch all” methods currently in use.

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Check out Nova BioLabs on @MedStartr Today Nova is developing a truly personalized cancer recurrence test that allows us to focus surveillance on an individual’s tumor abnormalities, instead of the “catch all” methods currently in use. #MedMo #MedStartrVentures

https://www.medstartr.ai/s/8sMHWEOHOmI

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Cancers discovered at earlier stages have a significantly (2 to 5 times) higher 5 year survival rate than later stages [1], so it comes as no surprise that early detection of recurrence is also associated with better outcomes [2-7].  Current recurrence surveillance guidelines are frequently limited to looking for signs of localized recurrence via a physical exam or in some instances with focused radiological methods, e.g. mammogram or CT scan [3,8-11]. Because focused scans fail to look for signs of recurrence at distal sites, they fail to fully protect patients in this regard. However, we are now at a turning point in the management of cancer, as we are approaching a critical mass of enthusiasm, technology, and data all supporting the application of cell-free DNA (cfDNA) analysis for the prediction, diagnosis, and surveillance of this terrible disease. Cancer leaves traces of itself in the bloodstream, and we can detect these traces in one form via the presence of circulating tumor DNA (ctDNA) [12-15]. ctDNA detection via a blood draw is advantageous over existing methods of recurrence testing in that 1) it is capable of detecting localized or distal recurrence 2) it offers incredible specificity and sensitivity and 3) it is convenient for the patient - blood draws can be taken at home, work, or in the clinic. The application of ctDNA detection for cancer recurrence monitoring is beyond theoretical now, as the results from one clinical trial have shown that ctDNA detection from a blood draw preceded identification of recurrence by CT scan by up to a year [16]. As described below in the "FDA Status" section, we anticipate, but it has yet to be confirmed, that we will require FDA approval to fully commercialize our test.  We are currently in the process of formalizing an agreement with a local hospital system to gain access to patients required for any studies the FDA will require, as well as to gain credibility in the oncology community as a whole.  Having additional access to patients via “crowdsourcing” would obviously be advantageous, however we do anticipate time-sensitive collection of samples (i.e. post-diagnosis and pre-treatment). Additionally, identifying participants for longitudinal studies would be welcome.   <ol> <li> SEER*Explorer: An interactive website for SEER cancer statistics [Internet]. Surveillance Research Program, National Cancer Institute. [Cited 2017 Apr 14]. Available from <a href="https://seer.cancer.gov/explorer/">https://seer.cancer.gov/explorer/</a>. </li> <li> Lu, W.L., Jansen, L., Post, W.J., Bonnema, J., Velde, J.C.V.D., Bock, G.H.D., 2008. Impact on survival of early detection of isolated breast recurrences after the primary treatment for breast cancer: a meta-analysis. Breast Cancer Research and Treatment 114, 403–412. doi:10.1007/s10549-008-0023-4 </li> <li> Young, P.E., Womeldorph, C.M., Johnson, E.K., Maykel, J.A., Brucher, B., Stojadinovic, A., Avital, I., Nissan, A., Steele, S.R., 2014. Early Detection of Colorectal Cancer Recurrence in Patients Undergoing Surgery with Curative Intent: Current Status and Challenges. Journal of Cancer 5, 262–271. doi:10.7150/jca.7988 </li> <li> Creutzberg, C.L., Putten, W.L.V., Koper, P.C., Lybeert, M.L., Jobsen, J.J., Wárlám-Rodenhuis, C.C., Winter, K.A.D., Lutgens, L.C., Bergh, A.C.V.D., Steen-Banasik, E.V.D., Beerman, H., Lent, M.V., 2003. Survival after relapse in patients with endometrial cancer: results from a randomized trial?. Gynecologic Oncology 89, 201–209. doi:10.1016/s0090-8258(03)00126-4 </li> <li> Hung JJ,  Hsu WH, Hsieh CC,  Huang BS, Huang MH,  Liu JS, et al. Post-recurrence survival in completely resected stage I non-small cell lung cancer with local recurrence, Thorax , 2009, vol. 64 (pg. 192-6) </li> <li> Hung JJ,  Jeng WJ, Hsu WH,  Wu KJ, Chou TY, Hsieh CC, et al. Prognostic factors of postrecurrence survival in completely resected stage I non-small cell lung cancer with distant metastasis, Thorax , 2010, vol. 65 (pg. 241-5) </li> <li> Cormier, J., Voss, R., Woods, T., Cromwell, K., Nelson, K., 2015. Improving outcomes in patients with melanoma: strategies to ensure an early diagnosis. Patient Related Outcome Measures 229. doi:10.2147/prom.s69351 </li> <li> Schneble, E.J., Graham, L.J., Shupe, M.P., Flynt, F.L., Banks, K.P., Kirkpatrick, A.D., Nissan, A., Henry, L., Stojadinovic, A., Shumway, N.M., Avital, I., Peoples, G.E., Setlik, R.F., 2014. Current Approaches and Challenges in Early Detection of Breast Cancer Recurrence. Journal of Cancer 5, 281–290. doi:10.7150/jca.8016 </li> <li> Colombo, N., Preti, E., Landoni, F., Carinelli, S., Colombo, A., Marini, C., Sessa, C., 2013. Endometrial cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology 24, vi33–vi38. doi:10.1093/annonc/mdt353 </li> <li> Colt, H.G., Murgu, S.D., Korst, R.J., Slatore, C.G., Unger, M., Quadrelli, S., 2013. Follow-up and Surveillance of the Patient With Lung Cancer After Curative-Intent Therapy. Chest 143. doi:10.1378/chest.12-2365 </li> <li> Trotter, S.C., Sroa, N., Winkelmann, R.R. et al, A global review of melanoma follow-up guidelines. J Clin Aesthet Dermatol. 2013;6:18–26. </li> <li> Alix-Panabieres, C., Pantel, K., 2016. Clinical Applications of Circulating Tumor Cells and Circulating Tumor DNA as Liquid Biopsy. Cancer Discovery 6, 479–491. doi:10.1158/2159-8290.cd-15-1483 </li> <li> Strickler, J.H., Loree, J.M., Ahronian, L.G., Parikh, A.R., Niedzwiecki, D., Pereira, A.A.L., Mckinney, M., Korn, W.M., Atreya, C.E., Banks, K.C., Nagy, R.J., Meric-Bernstam, F., Lanman, R.B., Talasaz, A., Tsigelny, I.F., Corcoran, R.B., Kopetz, S., 2017. Genomic landscape of cell-free DNA in patients with colorectal cancer. Cancer Discovery. doi:10.1158/2159-8290.cd-17-1009 </li> <li> Tie, J., Wang, Y., Tomasetti, C., Li, L., Springer, S., Kinde, I., Silliman, N., Tacey, M., Wong, H.-L., Christie, M., Kosmider, S., Skinner, I., Wong, R., Steel, M., Tran, B., Desai, J., Jones, I., Haydon, A., Hayes, T., Price, T.J., Strausberg, R.L., Diaz, L.A., Papadopoulos, N., Kinzler, K.W., Vogelstein, B., Gibbs, P., 2016. Circulating tumor DNA analysis detects minimal residual disease and predicts recurrence in patients with stage II colon cancer. Science Translational Medicine 8. doi:10.1126/scitranslmed.aaf6219 </li> <li> Wyatt, A.W., Annala, M., Aggarwal, R., Beja, K., Feng, F., Youngren, J., Foye, A., Lloyd, P., Nykter, M., Beer, T.M., Alumkal, J.J., Thomas, G.V., Reiter, R.E., Rettig, M.B., Evans, C.P., Gao, A.C., Chi, K.N., Small, E.J., Gleave, M.E., 2017. Concordance of Circulating Tumor DNA and Matched Metastatic Tissue Biopsy in Prostate Cancer. JNCI: Journal of the National Cancer Institute 110. doi:10.1093/jnci/djx118 </li> <li> Abbosh, Christopher, et al. “Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution” Nature, vol. 545, no. 5, May 2017, pp. 446-451., doi:10.1038/nature22364 </li> </ol>

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