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The test, which is used to screen for cervical cancer, was previously approved by the agency for use with the Cobas 4800 system.
The biomarker-based test determines women whose human papillomavirus infections are most likely to be associated with cervical pre-cancers.
The system showed good performance for cervical samples as well as orophyrengeal samples, and required no extraction step.
The assay, which received premarket approval last year, detects 14 high-risk HPV types and individually identifies and reports HPV genotypes 16, 18, and 45.
The new test uses the number of sequencing reads at specific early and late HPV transcripts as a biomarker for high-grade cytology.
The system has been evaluated by researchers studying cervical cancer prevention as well as other HPV-related cancers, with positive feedback so far.
The Singapore-based company will debut a system at AACC that performs real-time PCR flu A/B testing in less than 20 minutes for the cost of a lateral flow test.
The company — develops tests for the early detection of cancer and other diseases in whole blood — is targeting C$3.7 million in a private placement financing round.
Last year, the firm saw 21 percent growth in reproductive health, 56 percent growth in oncology, and 49 percent growth in infectious disease testing.
A pair of new studies evaluated the effectiveness of cytologic and HPV-based testing approaches at varied screening intervals for identifying women at risk of cervical cancer.