iCS-digital TM PSC

The iCS-digital TM PSC test detects more than 90% of recurrent genomic abnormalities
in human pluripotent stem cells (hPSCs).

Cell types

Human PSCs:
ESCs & iPSCs

Stages

- Reprogramming
- Derivation
- Maintenance
- Differentiation
- Gene editing

Samples

- gDNA
- Cell culture supernatant
(> 70% confluence)
- Cell pellet

Shipment

- Room temperature
- Room temperature
.
.
- Dry ice

Coverage

Test with 24 probes: 91% of recurrent abnormalities

Test with 12 probes: 76% of recurrent abnormalities

Mosaicism

>20%
(depending on sample quality)

Time

2-3 days
after sample reception

Definition of recurrent genomic abnormalities and rationale for regular testing

In culture, human pluripotent stem cells (hPSCs) may develop recurrent genomic abnormalities. These defects, essentially copy number variations (CNVs), are a major concern because they reflect a selection pressure that may favour hPSC proliferation and survival, or reduce their differentiation capacities*.

We specifically analysed the data from 100 scientific publications concerning 942 hPSC samples. After exclusion of polymorphic variants, we highlighted the presence of 738 recurrent genetic abnormalities (i.e., genomic defects found in at least five different publications).

We then used these data to develop the in Culture Supernatant-digital PCR (iCS-digital TM) PSC test. This assay includes a set of 24 specific probes that were designed and optimized based on the most reported altered sequences and that allows detecting, by digital PCR, more than 90% of recurrent genetic abnormalities in hPSC supernatant (patented technology). A version of the iCS-digital TM PSC test that includes 12 probes allows the detection of 76% of the recurrent genetic abnormalities.

The test is published in Stem Cell Reports**.

Thanks to the simplicity of the collection method and the rapidity of the analysis, the iCS-digital TM PSC test is a straightforward method for monitoring cell lines at regular intervals in culture, for controlling the cells before initiating critical and costly steps (banking, differentiation), and for screening hPSC clones after reprogramming or gene editing.

Percentage of cumulated recurrent abnormalities detected in function of the number of probes targeting specific genomic sequences

iCS-digital TM PSC test result

* Assessing the Genome Integrity of Human Induced Pluripotent Stem Cells: What Quality Control Metrics? Stem Cells 2018 Jun;36(6):814-821.
** Recurrent Genetic Abnormalities in Human Pluripotent Stem Cells: Definition and Routine Detection in Culture Supernatant by Targeted Droplet Digital PCR. Stem Cell Reports 2020 Jan14;14(1):1-8.

The iCS-digital TM PSC test is a non-invasive tool to detect the vast majority of recurrent genomic abnormalities for the routine monitoring of human PSC genomic stability. This new test can change how quality control is implemented for PSC use in basic research and regenerative medicine.

iCS-digital TM PSC