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HPV

The clearance covers tests made by the firm's joint venture for manufacturing, CoSara Diagnostics, in its facility in Ranoli, India.

The flow cytometry-based assays were developed by Menlo Park, California-based IncellDx to run on Beckman Coulter instrumentation.

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 agreement enables NeuMoDx to bring sample-to-result HPV screening to customers in Europe, where its systems are distributed by Qiagen.

The company said that the decline in revenues reflected lower industry-wide reimbursement rates under PAMA.

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.

In an earnings call, the firm said it sees growth continuing for the BD Max, BD Cor, and Phoenix systems, and in China in general.

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 high-throughput, scalable BD Cor system for infectious disease diagnostics is now available in Europe with the firm's BD Onclarity HPV assay. 

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