Integration Site Analysis Patient Sample Testing

1. 7. Will I be notified if there’s a delay?

The requesting physician will receive an email notification of any issues (i.e., repeat test, delays, etc.).

1. 8. What should I expect in an ISA report?

ISA testing is reported as a summary report, including:

• Sample specifications (as provided on requisition form)
• ISA method summary
• Integration site (IS) counts are a reflection of vector-copy number and presence/lack of clonal outgrowth. Higher counts (e.g., comprising of thousands of different IS locations) correlate with more successful treatment and reduced risk.
• The report will include the ten most prominent IS locations with estimation of clonal size, nearby gene name, and IS location specification (chromosome number, sequence orientation (plus or minus), and locus of the IS based on human reference genome). Higher IS frequencies, especially IS locations which increase over time, indicate clonal dominance.
• While oligoclonality itself will not a priori result in a malignancy, IS relative frequency may suggest the emergence of clonal hematopoiesis, which may be associated with an increased risk of a malignancy.
• A sample IS summary report can be found here.

1. 9. Which states is ProtaGene accepting samples from?

ProtaGene is currently accepting samples from the following states: AL, AK, AZ, AR, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NC, ND, OH, OK, OR, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and, WY.

ProtaGene has received its Clinical Laboratory Improvements Amendments (CLIA) Certificate of Registry from the state of Massachusetts. Additional state CLIA licenses are being obtained to allow receipt of patient samples from all US states.

1. 10. What if I have more questions?

Please complete the inquiry form below, and we will respond within 2 business days.