SeekIn is prepared to launch its LeukoPrint Molecular Karyotyping Test in European markets following receipt of CE Mark approval.
The new kit, intended for the diagnosis of leukaemias, has been designed to identify the copy number aberration (CNA) patterns in leukaemia patients depending on shallow whole-genome sequencing (sWGS).
It can also assist haematologists in diagnosing and prognostic stratifying according to the European Leukemia Net (ELN), Revised International Prognostic Scoring System (IPSS-R) or Revised International Staging System (R-ISS) guidelines.
Leukaemias are a set of malignant blood and bone marrow disorders that can occur at any age.
Additionally, LeukoPrint is suitable for many other forms of haematological malignancies, such as multiple myeloma.
SeekIn founder and CEO Mao Mao said: “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.
“LeukoPrint provides a cost-effective and simplified method for prompt and accurate CNA profiling in leukaemia patients. It utilised a standardised 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.”
The company further plans to receive regulatory approvals in other territories, such as China.
It claims that the new test provides high accuracy as well as sensitivity and that it can help patients avoid pain from needing to give multiple bone marrow samples.
LeukoPrint also makes molecular subtyping, prognostic stratification and treatment response monitoring accurate and comprehensive.