NIMGenetics, Turnkey Solutions for Genomic Stability and Identity Requirements

NIMGenetics, founded in 2008, is an innovative, privately owned, European company specialized in the design and commercialization of high-performance products and services for genetic diagnosis.

Headquartered in Madrid, Spain, its scientific-medical team is professionally and scientifically accredited by the Spanish Association of Human Genetics, specializing in the development and application of high resolution genomic systems for reliable and accurate clinical diagnosis.

In addition to its scientific staff releasing more than 300 international publications in the field of human genetics and molecular biology, NIMGenetics’ Analytical Diagnostic Center with Genetics unit has been authorized by the Regional Ministry of Health of the Community of Madrid Spain.

At present, more than 50 diagnostic centers, clinics and hospitals use its services, with this number expanding on a year-over-year basis.

Detecting and Controlling Genomic Instability

The necessity of detecting/controlling genomic instability of cultured cells inspires current developments worldwide, as evidenced in the USA, Europe and India.[1]

In addition, cell line cross-contamination has become endemic. It is estimated that around 15% of human cell lines are contaminated and, as a result, more and more prestigious journals are asking authors to report the source of their cell lines and whether the cell line has been authenticated.[2]

NIMGenetics, Your Partner in Genomic Instability and Cross-contamination Studies

To solve these challenges, NIMGenetics is positioned to provide turnkey solutions for your genomic instability and cross-contamination studies.

Its multidisciplinaray expert team integrates the most appropriate and effective technologies for the study of genetic instability and cross-contamination, including:

• Array CGH (with the proprietary KaryoNIM Stemcells platform)
• FISH (with customized NIMFISH probes)
• Karyotyping
• NGS with comprehensive cancer-related panels
• Expression profiles using whole transcript arrays
• STR analysis (Other studies such as WES, WGS, telomerase activity and telomere length are available on request)

NIMGenetics Array CGH Platform for Stem Cells

Recently, NIMGenetics has expanded into the stem cell therapy field, to allow for genetic screening of stem-cell based products.

Cell therapy consists of using adult or embryonic stem cells to treat diseases associated with tissue degeneration caused by autoimmune diseases, trauma or aging. Stem cells are generally expanded over 15-20 cell divisions under replicative and metabolic stress so as to obtain sufficient quantity to proceed with cell therapy treatments.

This expansion can significantly increase the amount of chromosome aberrations which reduce the suitability for use in cell therapy.[3,4,5]

For this reason, the European Medicines Agency (EMA) recommends the genetic screening of stem-cell based medical products.[6]

To support this recommendation, NIMGenetics has developed KaryoNIM® Stem Cells, an array CGH platform that analyses the molecular karyotype of stem cells. In addition, KaryoNIM® Stem Cells has been design using the most recent literature and data bases, and includes 407 genes with duplications or deletions associated with genomic instability and abnormal growth.

Advantages of KaryoNIM® Stem Cells include: 

1. Analyzes the complete genome to diagnose possible deletions and amplications, thus improving the diagnostic resolution of a conventional array CGH.
2. Uses DNA. No need to use metaphase cells, as only 50,000 frozen cells are needed or 0.5 micrograms of DNA.
3. A resolution 20 times higher than that of conventional karyotyping (250 kilobases against 5 megabases) with 5 to 20 probes per region of interest.
4. Identities and reports on all the genes involved in genomic alterations.
5. Specically designed for genomic identication of therapeutic cells in order to provide information on critical regions for biosecurity (TP53, hTERT, C-MYC, PTEN, CDKN2A, BRCA1…)
6. The results, ready in only 5 to 10 days, are prepared by board-certied medical geneticists from the Cytogenetics European Quality Association (CEQA), experts in genetic stability of stem cells.
7. Provides detailed information about aneuploidies from the total population of a cell culture against the 10 cells usually analyzed with conventional Karyotyping.

Learn More about NIMGenetics

To learn more about NIMGenetics turnkey solutions for genomic stability and indetity, please contact NIMGenetics at jrincon@nimgenetics.com or +34-617 427 477.

References, documents and additional information are available on request.

Footnotes

1. (A)“…to asses genetic stability of the MCB*/packaging cell line; and processes critical to product safety…” Guidance for FDA Reviewers and Sponsors. April 2008 ;
(B) “The genetic stability of the cells shall be demonstrated” Commision Directive 2009-120-EC 3.3.2.3.
(C)“Stringent characterization of the product with reference to its identity, purity and safety as well as genomic stability, tumorigenicity and potency is essential before its release for human use” National Guidelines for Stem Cell Research. Indian Council of Medical Research. 2013.
2. “Time to tackle cells” mistaken identity. Nature 520, 264. 2015.
3. Spits C et al. Recurrent chromosomal abnormalities in human embryonic stem cells. Nat Biotechnol 2008;26:1361-1363.
4. Estrada JC et al. Culture of human mesenchymal stem cells at low oxygen tension improves growth and genetic stability by activating glycolysis. Cell Death Differ 2011;9:97-102.
5. Yang S et al. Tumor progression of cultura-adapted human embryonic stem cells during long-term culture. Genes Chromosomes Cancer 2008;47(8):685-679.
6. EMA/CAT/571134/2009: “Reflection paper on stem cell-based medicinal products”.

Source: NIMGenetics