Skip to main content
Premium Trial:

Request an Annual Quote

Agilent Receives Approval for Microarray-Based Postnatal Assay in Japan

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

The Scan

Tara Pacific Expedition Project Team Finds High Diversity Within Coral Reef Microbiome

In papers appearing in Nature Communications and elsewhere, the team reports on findings from the two-year excursion examining coral reefs.

Study Examines Relationship Between Cellular Metabolism, DNA Damage Repair

A new study in Molecular Systems Biology finds that an antioxidant enzyme shifts from mitochondria to the nucleus as part of the DNA damage response.

Stem Cell Systems Target Metastatic Melanoma in Mouse Model

Researchers in Science Translational Medicine describe a pair of stem cell systems aimed at boosting immune responses against metastatic melanoma in the brain.

Open Pediatric Brain Tumor Atlas Team Introduces Genomic Data Collection, Analytical Tools

A study in Cell Genomics outlines open-source methods being used to analyze and translate whole-genome, exome, and RNA sequence data from the Pediatric Brain Tumor Atlas.