Precision Diabetes and Nagase Diagnostics Announce Exclusive U.S. Commercialization Partnership for Lucica® Glycated Albumin-L, the Only FDA-Cleared Glycated Albumin Assay
核心洞察
Precision Diabetes (搜索) and Nagase Diagnostics have entered an exclusive U.S. commercialization partnership for the Lucica® Glycated Albumin-L (搜索) assay, the only FDA 510(k)-cleared assay specifically measuring glycated albumin (搜索) in the United States.
The assay provides an intermediate-term glycemic assessment over the prior two to three weeks, complementing HbA1c and continuous glucose monitoring for individualized diabetes (搜索) management.
Lucica® Glycated Albumin-L (搜索) offers particular clinical utility in patients where HbA1c interpretation is confounded, including those on hemodialysis, with hemoglobinopathies (搜索), anemia (搜索), or during pregnancy.
Precision Diabetes, Inc. (搜索) and Nagase Diagnostics Co., Ltd. (搜索) announced on July 23, 2026 an exclusive U.S. commercialization partnership for the Lucica® Glycated Albumin (搜索) (GA)-L assay (510(k) No. K170147), the only assay with U.S. Food and Drug Administration (FDA) 510(k) clearance specifically intended to measure glycated albumin. The collaboration, unveiled from Raleigh, North Carolina and Itasca, Illinois, combines Nagase Diagnostics' global expertise in diagnostic reagent development with Precision Diabetes (搜索)' leadership in diabetes biomarkers, laboratory commercialization, and clinical education.
Under the agreement, Precision Diabetes (搜索) will serve as the exclusive U.S. commercial partner for the Lucica® Glycated Albumin-L (搜索) assay, leading market development, laboratory partnerships, customer engagement, physician education, and commercial initiatives designed to accelerate clinical adoption and expand patient access throughout the United States.
A Distinct Intermediate-Term Glycemic Biomarker
Unlike HbA1c, which reflects average blood glucose over approximately two to three months, Lucica® Glycated Albumin-L (搜索) provides an assessment of glycemic control over the previous two to three weeks, enabling clinicians to evaluate therapeutic response sooner following initiation or modification of diabetes (搜索) treatment. The assay specifically measures glycated albumin (搜索), distinguishing it from fructosamine, which measures glycated total serum proteins. This specificity provides greater analytical precision and a more targeted assessment of glycemia.
Growing clinical evidence has observed clinically meaningful associations between Lucica® Glycated Albumin-L (搜索) and Continuous Glucose Monitoring (CGM)-derived metrics, including mean glucose and time in range (TIR). These characteristics position the assay as an important complementary assessment of glycemic control alongside HbA1c and CGM, supporting clinical decision-making and individualized diabetes (搜索) management.
Addressing Unmet Needs in Special Populations
Lucica® Glycated Albumin-L (搜索) may be particularly useful in diabetes (搜索) patients with chronic kidney disease (搜索), especially those receiving hemodialysis, where interpretation of HbA1c may be affected by alterations in red blood cell survival. Because the assay is independent of red blood cell lifespan, it provides clinicians with additional information to consider in this challenging patient population.
The assay also provides complementary information on glycemic control during pregnancy, including gestational diabetes (搜索), and in diabetes (搜索) patients with hemoglobinopathies (搜索), anemia (搜索), erythropoietin therapy, or other conditions affecting red blood cell turnover.
Leadership Perspectives
Makise Hironao, Representative Director of Nagase Diagnostics Co., Ltd. (搜索), stated: "Lucica® Glycated Albumin-L (搜索) was developed to provide clinicians with an intermediate-term glycemic biomarker that complements traditional measures of glycemic control. By specifically measuring glycated albumin (搜索), the assay provides additional information in situations where HbA1c alone may not fully reflect glycemic status, including patients receiving hemodialysis and other conditions affecting red blood cell turnover. We are pleased to partner with Precision Diabetes (搜索) to expand access to this FDA-cleared diagnostic technology in the United States."
Eric A. Button, Founder and Chief Executive Officer of Precision Diabetes, Inc. (搜索), added: "We are excited to partner with Nagase Diagnostics to bring the Lucica® Glycated Albumin-L (搜索) assay to the U.S. market. This collaboration combines Nagase Diagnostics' scientific innovation with Precision Diabetes (搜索)' expertise in commercializing advanced diabetes biomarkers. Together, we look forward to expanding physician awareness and helping laboratories provide clinicians with an important new tool for individualized diabetes management."
Scientific Foundation and Commercial Trajectory
Nagase Diagnostics originally developed the enzymatic glycated albumin (搜索) assay in 2002. Today, the Lucica® Glycated Albumin-L (搜索) assay remains the market-leading glycated albumin assay in Japan and the only FDA-cleared assay intended to measure glycated albumin in the United States. The NAGASE Group operates over 100 group companies across approximately 25 countries and regions worldwide, spanning chemicals, electronics, mobility, energy, food, medical products, and biotechnology.
Precision Diabetes (搜索), based in Raleigh, North Carolina, is focused on enabling precision medicine for diabetes through novel diabetes biomarkers and diagnostic algorithms, with a mission to revolutionize diagnostic assessment across the continuum from diabetes risk assessment through detection and management of diabetes complications.
Through physician education, scientific collaboration, laboratory partnerships, and commercial support, the two companies are committed to expanding access to emerging diagnostic technologies that provide additional clinical information to support clinical decision-making and diabetes (搜索) management.