Courtesy of KSL Beutner Laboratories
Laminin 332 IIF-IgG4.F

Lab launches first blood test for a chronic, debilitating autoimmune disease

Aug. 19, 2022
A highly accurate IIF serological assay for laminin 332 mucous membrane pemphigoid reduces the wait for confirmed diagnosis from months or years to 72 hours or less.

KSL Beutner Laboratories has launched a first-to-market indirect immunofluorescence (IIF) serum blood test in the U.S. that positively identifies laminin 332, an antigen associated with the chronic, debilitating autoimmune disease mucous membrane pemphigoid (MMP). 

Without a definitive interpretation, patients experience considerable pain and suffering due to misdiagnosis and treatment delays. Long sought after by oral pathologists, oral surgeons, periodontists, dentists, and dermatologists, Beutner’s laminin 332-specific serological assay reduces the time to confirmed diagnosis from as much as two years to 72 hours or less.

MMP is an autoimmune blistering disease characterized by multisite lesions on mucous membranes. Anti-laminin 332 MMP lesions often scar and can lead to serious complications depending on the mucosal surfaces affected. Oral mucosa—gums, inner lining of the cheeks and lips, palate, and tongue—are involved in 80%–90% of cases. Scarring of ocular mucosa, present in half of patients, may lead to blindness. The disease can also impact mucous membranes in the nose, throat, genitals, and anus, causing severe, irreversible damage. Another complication in 25%–30% of patients is increased risk of cancer malignancies, primarily adenocarcinoma in the gastrointestinal and genital mucosa and lungs. The condition can be fatal if left untreated. Considered a rare disease of unknown cause, MMP occurs mainly in people between ages 60 and 80 and, infrequently, in children. Women are affected twice as often as men.

Confirming laminin 332 MMP relies on several laboratory tests offered by Beutner: first, a direct immunofluorescence (DIF) microscopy of a skin biopsy to detect tissue-bound immunoreactants. Although DIF is the gold standard for investigating all forms of MMP, it does not always differentiate between variants. Next, indirect immunofluorescence is applied to identify circulating antibodies targeting the autoantigens in the basement membrane zone (BMZ) of the skin. This type of analysis is done in two parts: an IIF test on salt-split skin and an IIF serum test on transfected cells for laminin 332 IgG/IgG4 antibodies using a EUROIMMUN assay. Beutner’s IIF serological assay has a sensitivity of 84% and a specificity of 99%. 

Source: press release dated August 2, 2022.

About KSL Beutner Laboratories

KSL Beutner Laboratories, a global innovator in immunodermatology, specializes in immunologic testing for the diagnosis of bullous, vascular, connective tissue and inherited skin diseases. It was founded by industry pioneer Dr. Ernst H. Beutner and his wife Gloria Beutner in 1992 after Dr. Beutner and his associates at the University at Buffalo discovered the role of autoimmunity in pemphigus and pemphigoid. The Beutner team developed reproducible diagnostic methods such as immunofluorescence (IF) for detecting the pathogenic autoantibodies that cause these diseases. KSL Beutner Laboratories provides anti-laminin 332 IIF serological testing as a service, as well as several other assays for laminin 332 MMP and for the BP180 variant of MMP. For more information or to order tests, visit their website.