Precision Diabetes and Nagase Diagnostics Announce Exclusive U.S. Commercialization Partnership for Lucica^® Glycated Albumin-L, the Only FDA-Cleared Assay Specifically Measured Glycated Albumin in the United States

Partnership expands access to a useful intermediate-term glycemic biomarker that complements HbA1c^1,2 and Continuous Glucose Monitoring³ while providing additional insights into glycemic status to support diabetes management.

Raleigh, North Carolina and Tokyo, Japan – [July 28] — Precision Diabetes, Inc. and Nagase Diagnostics Co., Ltd. today announced an exclusive U.S. commercialization partnership for the Lucica^® Glycated Albumin (GA) -L assay (510(k) No. K170147), the only assay with U.S. Food and Drug Administration (FDA) 510(k) clearance in the United States that is specifically intended to measure glycated albumin.

The collaboration combines Nagase Diagnostics’ global expertise in diagnostic reagent development with Precision Diabetes’ leadership in diabetes biomarkers, laboratory commercialization, and clinical education. Under the agreement, Precision Diabetes will serve as the exclusive U.S. commercial partner for the Lucica^® Glycated Albumin-L 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.

The introduction of the Lucica^® Glycated Albumin-L assay to a broader U.S. clinical audience represents an additional advancement by providing laboratories and healthcare professionals with an intermediate-term assessment of glycemia that complements traditional measures such as HbA1c^{1, 2}. As clinicians increasingly individualize diabetes management, Lucica^® Glycated Albumin-L provides additional clinical insights alongside conventional long-term glycemic markers.

Unlike HbA1c, which reflects average blood glucose over approximately two to three months, Lucica^® Glycated Albumin-L 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 treatment^{3, 4}.

Lucica^® Glycated Albumin-L may be particularly useful in diabetes patients with chronic kidney disease, especially those receiving hemodialysis, where interpretation of HbA1c may be affected by alterations in red blood cell survival⁵. 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, and in diabetes patients with hemoglobinopathies, anemia, erythropoietin therapy, or other conditions affecting red blood cell turnover⁶.

Growing clinical evidence has observed clinically meaningful associations between Lucica^® Glycated Albumin-L and Continuous Glucose Monitoring (CGM)-derived metrics, including mean glucose and time in range (TIR) ^3,7. Unlike fructosamine, which measures glycated total serum proteins, Lucica^® Glycated Albumin-L specifically measures glycated albumin, providing greater analytical specificity and a more targeted assessment of glycemia⁸. Together, these characteristics position Lucica^® Glycated Albumin-L as an important complementary assessment of glycemic control alongside HbA1c^1,2 and CGM³, supporting clinical decision-making and individualized diabetes management.

Makise Hironao, Representative Director, Nagase Diagnostics Co., Ltd. commented:

“Lucica^® Glycated Albumin-L was developed to provide clinicians with an intermediate-term glycemic biomarker that complements traditional measures of glycemic control. By specifically measuring glycated albumin, the assay provides additional information in situations where HbA1c alone may not fully reflect glycemic status, including patients receiving hemodialysis⁵ and other conditions affecting red blood cell turnover⁶. We are pleased to partner with Precision Diabetes to expand access to this FDA-cleared diagnostic technology in the United States.”

Eric A. Button, Founder & Chief Executive Officer of Precision Diabetes, Inc., added:

“We are excited to partner with Nagase Diagnostics, to bring the Lucica^® Glycated Albumin-L assay to the U.S. market. This collaboration combines Nagase Diagnostics’ scientific innovation with Precision Diabetes’ 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.”

The collaboration brings together decades of scientific innovation with specialized commercialization expertise to accelerate adoption of an additional testing technology in diabetes. Through physician education, scientific collaboration, laboratory partnerships, and commercial support, Nagase Diagnostics and Precision Diabetes are committed to expanding access to emerging diagnostic technologies that provide additional clinical information to support clinical decision-making and diabetes management.

About Precision Diabetes, Inc.

Precision Diabetes, Inc. (Raleigh, North Carolina) is an emerging leader in enabling precision medicine for diabetes through the use of novel diabetes biomarkers and diagnostic algorithms. The company's mission is to revolutionize the diagnostic assessment of diabetes by providing a spectrum of innovative diabetes tests spanning the continuum from diabetes risk assessment through the detection and management of diabetes complications.

Through strategic collaborations with leading diagnostic developers worldwide, Precision Diabetes is committed to bringing clinically meaningful technologies to laboratories and healthcare providers that improve clinical decision-making and patient outcomes.

About Nagase Diagnostics Co., Ltd.

Nagase Diagnostics Co., Ltd., a member of the NAGASE Group, manufactures more than one hundred enzymes used in clinical chemistry reagents, biosensors, and point-of-care testing applications. In 2002, the company developed the enzymatic glycated albumin assay, an intermediate-term glycemic biomarker reflecting average blood glucose over the previous two to three weeks. Today, the Lucica^® Glycated Albumin-L assay remains the only FDA-cleared assay intended to measure glycated albumin in the United States and the market-leading glycated albumin assay in Japan.

The NAGASE Group has over 100 group companies in approximately 25 countries and regions worldwide, operating in a wide range of fields including chemicals, electronics, mobility, energy, food, medical products, and biotechnology. NAGASE is not only a trading company, but also possesses manufacturing and R&D functions. By combining these functions with high-added-value information obtained through its global trading networks with customers around the world, NAGASE provides unique proposals and solutions to customer issues.

Media Contacts

Precision Diabetes, Inc.

Eric A. Button
Founder & CEO
ebutton@precisiondiabetesinc.com

Nagase Diagnostics Co., Ltd.

Corporate Web: https://group.nagase.com/nagasediagnostics/en/
Inquiries: https://group.nagase.com/nagasediagnostics/en/contact/lucica/

Reference

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Lucica^® is a registered trademark of Nagase Diagnostics.