48 Minimal Residual Disease (MRD) Solution | Research Use Only (RUO) Invivoscribe 2019 | 49 NGS RUO Assays LymphoTrackMinimal Residual Disease (MRD) Software Software Use The LymphoTrack MRD Bioinformatics Software package is provided with each LymphoTrack Assay upon request to enable monitoring of treatment response in many lymphoid malignancies such as Acute Lymphoblastic Leukemia and Multiple Myeloma to minimize the risk of patients relapsing. The exceptional sensitivity and precision of NGS-based MRD tracking can accelerate clinical trials and drug development. This MRD software is intended to detect the presence of clonotype sequences within the output files generated using the Invivoscribe LymphoTrack Assays and accompanying LymphoTrack bioinformatics software; it is not intended to define the significance of these findings. Once a specific rearrangement sequence (the clonotype) has been identified in a primary sample, the MRD software enables streamlined tracking of clonal populations at a sensitivity of 10-4 , or even lower limits provided sufficient DNA is tested. The MRD software can also be used for simultaneous objective tracking of bi-allelic sequences across multiple replicates for longitudinal subject tracking and in drug development studies. The provided software is composed of three distinct parts: 1. A bioinformatics Data Analysis Application 2.  A Project Planner that can be used to calculate confidence based on read depth, replicate count, and DNA input 3. PDF report identifying the clonotype sequence if present and summarizing the degree of mismatches, calculating the read frequency and the degree of confidence if a certain clonotype is not present at sensitivities of 10-3 , 10-4 , 10-5 , and 10-6 . Minimum Software Requirements • Processor: Intel Core 2 Duo or newer CPU recommended •  Hard Drive: At least 1 GB of free disk space is required; 2 GB recommended • RAM: 4 GB required; 8 GB or more recommended • Operating System: Windows 7 (64-bit) is required • A CD-ROM drive* LymphoTrack MRD Specimen Report This report summarizes the overall call, i.e. if a clonotype was detected or not detected, the number of checked replicates, the total DNA input, total reads analyzed and the location of all output files. The values in the PDF report are also found in the generated text files. Ordering Information Catalog # Products Quantity Components 7-500-0008 LymphoTrack® MRD Software** 1 CD complimentary with LymphoTrack kit purchase Sequence: #1 Sequence Name: On Target Sequence Replicate MRD Status Reads in Replicate 1 Sequence Detected 437731 CATCTGGATACACCTTCACCAGCTACTATATGCACTGGGTGCGACAGGCCCCTGGACAAGGGCTTGAGTGGATGGGAATAATCAACCCTAGTGGTGGGCACAAGCTA CGCACAGAAGTTCCAGGGCAGAGTCACCATGACCAGGGACACGTCCACGAGCACAGTCTACATGGAGCTGAGCAGCCTGAGATCTGAGGACACGGCCGTGTATT ACTGTGCTAGAGATCTCACAGGTTGTATTAGTACCAGCTGCTATCCTCCGAACTACTTTGACTACTGGGGCCAGGGAACCCT Sequence: #2 Sequence Name: Off Target Sequence Replicate MRD Status Reads in Replicate 1 Not Detected 437731 GCCTCTGGATTCACCTTCAGTAGGTACGACATGCACTGGGTCCGCCAAGGGACTGGAAAAGGTCTGGAGTGGGTCTCGGTTCCATCTCCAGAGAAAATGCCAAGAAC TCCTTGGATCTTCAAATGAACAGCCTGAGAGCCGGGGACACGGCTGCATATTACTGTGGAAGAAGATAGCAGTAGTCGTTGAGTACTGGGGCCAGGGAACCCT * If a CD-ROM drive is not available, please contact us at: support@invivoscribe.com MRD Project Planner The Project Planner can be used to calculate the confidence of a true negative by adding replicate counts, resequencing counts, sequencing depth, and DNA input amount. The software assumes that the same sequencing depth and DNA input is used for each replicate. Replicate Details Read Count Cumulative Read Count Cumulative Read Frequency Exact match 1281 1281 2.93 x 10-3 1 Mismatch 0 1281 2.93 x 10-3 2 Mismatch 0 1281 2.93 x 10-3 Replicate Details Read Count Cumulative Read Count Cumulative Read Frequency Exact match 0 0 0 1 Mismatch 0 0 0 2 Mismatch 0 0 0 Detection Limit % Confidence 1 x 10-3 N/A 1 x 10-4 N/A 1 x 10-5 N/A 1 x 10-6 N/A Detection Limit % Confidence 1 x 10-3 100% 1 x 10-4 99.89% 1 x 10-5 28.79% 1 x 10-6 2.0% ** MRD Software can be used to track sequences generated using either LymphoTrack® Assays formatted for either the Illumina® or Thermo Fisher® NGS platforms. MRD applications are for Research Use Only. To obtain a copy, please contact your local distributor or send an e-mail to MRD@invivoscribe.com MRD RUO Assays