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  1. Recently-Approved Devices

Alinity m HR HPV for use on the Alinity m System – P230003


This is a brief overview of information related to FDA’s approval to market this product.  See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval. 

Product Name: Alinity m HR HPV
Applicant: Abbott Molecular, Inc.
Address: 1300 E Touhy Avenue Des Plaines, IL 60018
Approval Date: November 1, 2023
Approval Letter: Approval Order

What is it?

The Alinity m HR HPV is a laboratory test used to detect human papillomavirus (HPV) genetic material, or viral DNA, in samples taken from the lower part of a patient’s uterus (cervix). The test can also identify certain virus types (genotypes) that increase the risk of someone developing cervical cancer. The test is designed for use on the Alinity m System, which runs the assay and analyzes the results. The test can evaluate cervical samples stored in either ThinPrep or SurePath preservative fluid.

How does it work?

A sample collected from the patient’s cervix, using an endocervical brush/spatula placed in ThinPrep or an endocervical broom placed in SurePath, and is sent to a clinical laboratory. At the laboratory, the sample is purified by the Alinity m System. The DNA collected from the sample is mixed with test chemicals. The Alinity m System then measures and reports if HPV viral DNA is found and what type of HPV was detected. The test can identify samples positive for HPV16, HPV18, or HPV45, while also detecting and differentiating the remaining 11 other high risk (HR) genotypes in two separate categories, Other HR HPV A (HPV 31/33/52/58) and Other HR HPV B (35/39/51/56/59/66/68).

When is it used?

The Alinity m HR HPV is used together with clinical information, medical history, and other laboratory results for routine cervical cancer screening as indicated by professional medical guidelines.

What will it accomplish?

Detecting and identifying HPV viral DNA levels in a patient’s sample, combined with other clinical information and test results, helps doctors determine if someone is at risk for developing cervical cancer. The doctor can then work with that person to make a management or treatment plan if needed.

In a clinical study of 14,702 people, the Alinity m HR HPV performed at acceptable levels compared to other FDA-approved tests for detecting HPV DNA in cervical specimens stored in ThinPrep and SurePath preservative fluid. The clinical study results, in combination with the non-clinical performance evaluations, support the effectiveness of the Alinity m HR HPV test for the intended use.

When should it not be used?

There are no known reasons not to use this test.

Additional information (including warnings, precautions, and adverse events):


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