Grifols announces availability in Europe of AlphaKit®QuickScreen, a novel point-of-care screening device to aid in the detection of Alpha-1-Antitrypsin Deficiency (AATD)


14.05.2014

  • AlphaKit® QuickScreen is a novel point-of-care immuno-chromatographic, in vitro diagnostic screening test for the Z-form of Alpha-1-Antitrypsin (Z-AAT). It is a qualitative test for the presence of the Z-AAT designed as an aid in the diagnosis of Alpha-1-Antitrypsin Deficiency (AATD). The test kit has been CE marked.
  • With a few drops of blood, the AlphaKit® QuickScreen is able to detect the presence of the Z-protein that is responsible for over 95% of severe AATD cases, a rare, life-threatening condition, after 15 minutes.
  • Alpha-1-Antitrypsin Deficiency (AATD) is estimated to affect more than 100,000 people in Europe, approximately 8,000 to 16,000 of which are in Germany and over 10,000 in Spain. It is estimated that more than 90% of individuals remain undiagnosed.
  • Germany will be the first EU country where the device will be distributed. The kit will be available in this country in May 2014 followed by Austria and other selected European markets.

Barcelona, 14 May, 2014.- Grifols a global healthcare company leader in lifesaving plasma therapies, today announced that AlphaKit® QuickScreen, a novel point-of care test for the screening of Alpha-1-Antitrypsin Deficiency (AATD), is now CE marked and will be available in selected markets in Europe very soon.

While rare, AATD is the most common cause of genetic emphysema in adults and the most common cause of liver disease in children. Individuals suffering from AATD often develop severe chronic obstructive pulmonary disease (COPD) leading to disability and premature death. AATD is estimated to affect 100,000 people in Europe alone, although more than 90% of individuals remain undiagnosed.

Now that the test kit is CE marked, the company will start to distribute the AlphaKit® QuickScreen progressively in the European Union countries. Germany will be the first country where the device will be distributed starting in May, launches in Austria, Spain, Italy and Portugal are also planned later in 2014.

The AlphaKit® QuickScreen is free of charge and represents a quick way for physicians and healthcare providers to screen COPD and emphysema patients for a unique genetic mutation commonly associated with AATD. Requiring only a few drops of blood, the AlphaKit® QuickScreen is able to detect the presence of the Z-protein that is responsible for over 95% of severe AAT deficiency cases in about 15 minutes.

"AAT deficiency can quickly be ruled out during a medical exam – and it only needs to be done once in a patient's life. If a patient tests positive, they are either a carrier of this genetic condition or are at risk of developing AAT deficiency emphysema," says Dr. Claus Vogelmeier, Professor of Internal and Respiratory Medicine at the Hospital of the Universities of Giessen and Marburg, Germany.  "Thus, we can proceed with a full diagnostic test to make the definitive diagnosis as we've always done and if appropriate, begin augmentation therapy".

Grifols currently provides a definitive and accurate diagnostic test, known as the AlphaKit® to physicians in several countries. The AlphaKit® has also been used to screen at-risk patients, and results are received in approximately two weeks. Grifols will continue to offer both the screening device and the diagnostic test, as they complement each other and facilitate detection of AATD. An early diagnosis allows patients to make informed decisions and provides the opportunity to make lifestyle changes that can add years to their lives. 

Pulmonologist Societies as well as the World Health Organization recommend that patients with COPD take a test for AATD once in their life

The most common symptoms of AATD are usually associated with a progressive loss of pulmonary function. If the patient does not receive suitable treatment this may lead to pulmonary emphysema which may eventually result in death, if the patient does not receive a lung transplant. These symptoms are the same as for COPD. Many patients are treated for COPD, but the real underlying cause, the AATD, is left untreated and the diagnosis may take up to 10 years. For this reason international guidelines issued by the ATS/ERS and the WHO recommend that patients with COPD be tested for Alpha-1-Antitrypsin Deficiency once in their life to rule out the possibility that they are carriers of the most common genetic mutation: phenotype Z.1,2   In addition, the CE-certified test also supports the implementation of the COPD guidelines of the German Society of Pneumology and Respiratory Medicine (DGP)3.

The estimated prevalence of Alpha-1-Antitrypsin Deficiency is 25 cases per 100,000 people4: a higher prevalence than other rare lung diseases such as cystic fibrosis or pulmonary hypertension. An analysis of the prevalence in Europe shows the estimated number of patients affected by AATD to reach approximately 100,000 people. However, more than 90% of those potentially affected are undiagnosed. Experts consider that approximately only 5% of people affected receive a suitable diagnosis. In Germany between 8,000 and 16,000 people approximately have Alpha-1 Antitrypsin Deficiency. Is estimated to affect over 10,000 people in Spain.

About Grifols

Grifols is a global healthcare company with a 70-year legacy of improving people's health and well being through the development of life-saving plasma medicines, diagnostics systems, and hospital pharmacy products.

The company is present in more than 100 countries worldwide and is headquartered in Barcelona, Spain. Grifols is a leader in plasma collection with a network of 150 plasma donor centers in the U.S., and a leading producer of plasma-derived biological medicines. The company also provides a comprehensive range of transfusion medicine, hemostasis, and immunoassay solutions for clinical laboratories, blood banks and transfusion centers, and is a recognized leader in transfusion medicine.

In 2013, sales exceeded 2,740 million euros with a headcount of 13,200 employees. Grifols demonstrates its commitment to advancing healthcare by allocating a significant portion of its annual income to R&D.

The company's class A shares are listed on the Spanish Stock Exchange, where they are part of the Ibex-35 (MCE:GRF).  Its non-voting class B shares are listed on the Mercado Continuo (MCE:GRF.P) and on the U.S. NASDAQ via ADRs (NASDAQ: GRFS). For more information visit www.grifols.com.


1ATS/ERS: Standards for the Diagnosis and Management of Individuals with Alpha-1 Antitrypsin Deficiency. Am J Respir Crit Care Med 2003; 168: 818–900
2 α1-Antitrypsin deficiency: Memorandum from a WHO meeting. Bulletin of the World Health Organization 1997; 75: 397-415
3Vogelmeier C et al. Leitlinie der Deutschen Atemwegsliga _ Pneumologie 2007; 61: e1_e40
4Orphanet Report Series – Prevalence of rare diseases: Bibliographic data – Nov 2013; www.orpha.net