NEW YORK ─ Agilent Technologies on Tuesday announced it has obtained clearance from Japan's Ministry of Health, Labour, and Welfare for its GenetiSure Dx Postnatal Assay, bringing comparative genomic hybridization to diagnostic settings in that country.
Santa Clara, California-based Agilent said it anticipates launching the assay in Japan in the first half of 2021.
The test enables clinical geneticists to detect genetic aberrations associated with developmental delay, intellectual disabilities, congenital anomalies, and unexplained dysmorphic features, the firm said.
Based on a microarray for comparative genomic hybridization, the assay is used for the postnatal diagnosis of copy-number alterations and copy-neutral loss of heterozygosity from DNA obtained from peripheral whole blood in patients who have been referred for chromosomal testing based on clinical presentation.
The assay has been available since 2017 as a diagnostic test in Europe and the US, and has been clinically validated using 900 samples, Agilent said.
The company further announced the registration of its microarray scanner, SureScan Dx Scanner, as a Class I medical device in Japan. Agilent's postnatal assay is used along with the SureScan Dx Scanner and CytoDx Software