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Emergency testing related to the SARS-CoV-2 pandemic strongly increased, but routine testing declined due to fewer regular health checks.
The test, which is used to screen for cervical cancer, was previously approved by the agency for use with the Cobas 4800 system.
The company began offering testing to clinicians in the first quarter of this year and expects volume to grow significantly over the next several months.
The biomarker-based test determines women whose human papillomavirus infections are most likely to be associated with cervical pre-cancers.
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.