The first-ever device for consumers to screen for alpha-1 antitrypsin deficiency (AATD) will be available for adults in the United States in the second quarter of 2023.

The US Food and Drug Administration (FDA) approved Grifols’ AlphaID™ genetic test as the first at-home screen for AATD.

“Many COPD patients don’t know their condition could be caused by alpha-1 because its symptoms are similar to those of COPD or asthma,” said Scott Santarella, president and CEO of the Alpha-1 Foundation, pointing out that November is awareness month for alpha-1 and COPD. “We wholeheartedly support initiatives and innovations that contribute to the diagnosis of alpha-1.”


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AATD is a hereditary condition in which patients lack the AAT protein, which protects lung tissue from neutrophil elastase, a highly destructive enzyme in the body that is released during infections or upon exposure to tobacco smoke.

Read more about AATD diagnosis

AATD significantly increases the risk of chronic obstructive pulmonary disease, a condition that approximately 16 million Americans have but many more are suspected to be undiagnosed. In fact, over 90% of AATD cases are thought to be undiagnosed, therefore, this direct-to-consumer product will be of significant diagnostic value to patients and healthcare providers. No prescription is needed.

The easy-to-use test screens for the most common genetic mutations associated with AATD, including rare and null alleles, as well as the S, Z, F, and I alleles. Users simply collect a saliva sample, send it to a laboratory for processing, and they will receive a report via a secure online portal within a few weeks.

A study on the ease of comprehension of the reports generated by AlphaID showed a 90% or greater level of understanding among a broad US demographic. Patients are encouraged to share the test results with their physician and discuss possible therapeutic options.

Reference

Grifols receives FDA clearance for AlphaID™ At Home, the first free service for U.S. consumers to determine their risk for alpha-1. News release. Grifols; November 3, 2022.