The firm is lowering its guidance due to anticipated revenue loss related to remediation efforts associated with its Alaris pump system.
The system showed good performance for cervical samples as well as orophyrengeal samples, and required no extraction step.
The company said it has started the CE mark approval process of commissioned high-risk HPV genotyping assays and expects to certify them this year.
The clearance covers tests made by the firm's joint venture for manufacturing, CoSara Diagnostics, in its facility in Ranoli, India.
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.
