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SeekIn receives CE Mark approval for LeukoPrint molecular karyotyping test

08 April 2022 | News

LeukoPrint Molecular Karyotyping Kit is developed to depict CNA patterns in leukemia patients based on shallow whole-genome sequencing (sWGS)

Image credit: shutterstock

Image credit: shutterstock

SeekIn Inc, the leader in blood-based cancer early detection and monitoring technology, has announced the CE (Conformité Européenne) Mark for LeukoPrint Molecular Karyotyping Kit and is now ready to launch this test in European markets.

Leukemias are a group of life threatening malignant disorders of the blood and bone marrow, which can occur at any age. There are a total of ~ 4.4 million new cases of and ~ 3.1 million deaths from leukemia worldwide annually. Genomic alternations, especially copy number aberrations (CNAs), are particularly imperative for diagnostic classification and risk stratification in leukemia patients. The conventional cytogenetic analysis, karyotyping, has been used to detect the genetic alterations of the hematopoietic malignancies for decades. Although karyotyping can provide a panoramic view of chromosomal aberrations, this technique comes with several drawbacks, such as a time-consuming and prone-to-failure cell-culturing step, relatively low resolution which is usually unable to detect submicroscopic changes (< 10 Mb), and a visual interpretation that is highly dependent on cytogeneticist experience and knowledge of the disease.

LeukoPrintMolecular Karyotyping Kit is developed to depict CNA patterns in leukemia patients based on shallow whole-genome sequencing (sWGS). This test can help hematologists make diagnosis and prognostic stratification according to European Leukemia Net (ELN), Revised International Prognostic Scoring System (IPSS-R) or Revised International Staging System (R-ISS) guidelines. Except for leukemias, LeukoPrint is also applicable to other types of hematological malignancies such as multiple myeloma. The significant advantage of LeukoPrint is high accuracy, high sensitivity, and patients can avoid the pain of frequent sampling from bone marrow.

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