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The deal to create a comprehensive genomic profiling test for Illumina's NextSeq 550Dx comes months after the instrument received regulatory approval in China.
Despite challenges related to the coronavirus pandemic, the Chinese precision oncology firm reported total quarterly revenues of RMB131.7 million ($20.2 million).
The company is working to expand access to its liquid biopsy assay outside of the US, after receiving US Food and Drug Administration approval last year.
The WHO and FIND are supporting NGS-based testing in low-resource settings, while a resistance testing program at New York State's Wadsworth Center has matured.
The deal builds on a non-exclusive partnership signed in January 2019 and PierianDx will now support three more Illumina cancer sequencing assays.
The xT platform integrates structured clinical patient data with results from a 648-gene DNA panel and whole-transcriptome RNA sequencing.
The company holds a leading position in reproductive testing and is expected to rapidly grow its oncology business to address a total market of $21 billion.
Thermo Fisher said the assay is the first and, so far, only FDA-approved test of its kind for a targeted treatment for RET fusion-positive NSCLC.
The trial will use Natera's Signatera test to determine patient enrollment eligibility based on the presence of ctDNA and to evaluate response based on ctDNA clearance.
The in vitro diagnostic test runs on the Illumina NovaSeq 6000 instrument and will be performed at Helix's San Diego CLIA-certified laboratory.