May 11, 2023
Grifols launches AlphaID™ At Home, enabling U.S. consumers to self-screen for genetic COPD
- Now available in the U.S., this free, innovative genetic health risk service lets consumers screen for their risk of alpha1-antitrypsin deficiency (alpha-1) through a small saliva sample they can collect right at home without needing to visit a healthcare professional
- Alpha-1 is the most common genetic risk factor for chronic obstructive pulmonary disease (COPD), a group of respiratory diseases affecting around 16 million Americans and the fourth-leading cause of death in the U.S.1
- As the leader in alpha-1 screening, Grifols wants to reach the more than 90% of people with alpha-1 believed to be undiagnosed2
Barcelona, Spain, May 11, 2023 – Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), a global leader in plasma-derived medicines and innovative diagnostic solutions, today announced it has launched its AlphaID™ At Home Genetic Health Risk Service (AlphaID™ At Home), the first-ever free direct-to-consumer program in the U.S. to screen for the genetic risk of alpha1-antitrypsin deficiency (alpha-1).
Alpha-1, also known as genetic COPD (chronic obstructive pulmonary disease), is estimated to impact 1 in every 2,500 Americans.3 With AlphaID™ At Home people can collect a small saliva sample without needing to visit a healthcare professional to learn their risk of developing lung and/or liver disease linked to alpha-1.
Genetic COPD develops due to a genetic deficiency of alpha1 antitrypsin, a protective plasma protein that safeguards the lungs from inflammation caused by infection and inhaled irritants such as tobacco smoke. Many COPD patients don’t realize their condition could have a genetic component, even though medical guidelines and the COPD Foundation suggest they get screened to learn their genetic risk for alpha-1.
“Given the fact that it can take several years until a patient with alpha-1 is properly diagnosed, AlphaID™ At Home can indicate someone’s risk for alpha-1 in a matter of weeks,” said Antonio Martínez, President of Grifols Diagnostic. “It’s a patient-friendly way to make a sophisticated genetic test simple and understandable.”
Pia D’Urbano, President of Grifols Biopharma, added: “Our hope is that through AlphaID™ At Home we can increase awareness about alpha-1 and accelerate diagnosis through the ease of at-home testing. This important screening service further strengthens Grifols' firm commitment to the alpha-1 community."
“We wholeheartedly support initiatives and innovations that contribute to the diagnosis of alpha-1. As leaders in alpha-1 testing, Grifols is doubling down on its commitment to the alpha-1 community by making it easier and more efficient to get diagnosed,” said Scott Santarella, President & CEO of the Alpha-1 Foundation. “This is incredible news for our community and will help patients go on to lead healthier lives.”
AlphaID™ At Home is now available to order in the U.S. without cost through a secure HIPAA-compliant online portal. Once the at-home screening kit arrives, individuals simply collect their saliva sample and send it to a CLIA-certified lab for processing. After a few weeks, they can access their genetic results on the secure online portal. Individuals are encouraged to share the results with their doctor, as only a healthcare provider can make a diagnosis of alpha-1.
Cleared by the U.S. Food and Drug Administration (FDA) in November 2022 for direct-to-consumer use*, AlphaID™ At Home screens for the 14 most prevalently reported genetic mutations associated with alpha-1 – the most of any test of its kind – including the S, Z, F, I alleles, as well as rare and null alleles.
AlphaID™ At Home uses the same accurate genotyping test Grifols has manufactured and made available to physicians globally since 2018 to screen for alpha-1, a focus on diagnosis that has led to more than 1 million patients being screened with Grifols solutions over the last 20 years.
To order a free AlphaID™ At Home kit, please visit www.alphaidathome.com.
To learn more about genetic COPD, please visit www.geneticCOPDtest.com.
To learn more about alpha-1, please visit the Alpha-1 Foundation at www.alpha1.org.
*AlphaID™ At Home is cleared for U.S. residents 18 years or older. The receipt of this free testing service does not create any expectation or obligation to purchase or use any product or service offered by any manufacturer.
1Chronic Obstructive Pulmonary Disease. Centers for Disease Control and Prevention. Accessed October 31, 2022. Chronic Obstructive Pulmonary Disease (COPD) | CDC
2Campos MA, Wanner A, Zhang G, Sandhaus RA. Trends in the diagnosis of symptomatic patients with α1-antitrypsin deficiency between 1968 and 2003. Chest. 2005;128(3):1179-1186.