SeekIn Inc, the leader in blood-based cancer early detection and monitoring technology, today 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.

LeukoPrint^® Molecular 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.

"With the advent of new DNA sequencing technologies, next-generation sequencing (NGS) based genetic testing has been implemented as a routine protocol for cancer diagnosis, risk stratification, and treatment response evaluation." Mao Mao, M.D., Ph.D., SeekIn's founder and CEO, said in a statement. "LeukoPrint provides a cost-effective and simplified method for prompt and accurate CNA profiling in leukemia patients. It utilized a standardized protocol which can be readily extended to clinical laboratories worldwide. With the advantage of detecting CNAs of short DNA fragments, by incorporating with the routine diagnostic methods, LeukoPrint can benefit the conventional cytogenetics by improving diagnostic yield. CE Marking represents a significant milestone for SeekIn in bringing LeukoPrint test to the patients and healthcare providers in Europe. We will continue our efforts to meet additional regulatory requirements in Europe, and to obtain regulatory approvals in the other territories such as China."