Agilus Introduces Claudin 18.2 Test for Enhanced Cancer Diagnosis in India

The test focuses on identifying the Claudin 18.2 protein, a key biomarker associated with gastric, pancreatic, and other cancers.

Agilus Diagnostics has launched the Claudin 18.2 test, a specialized diagnostic tool aimed at improving cancer care in India.

The test focuses on identifying the Claudin 18.2 protein, a key biomarker associated with gastric, pancreatic, and other cancers.

The move comes at a crucial time as gastric cancer ranks as the fifth most common cancer in men and seventh in women in India, with limited treatment options available.

Improved Diagnostic Precision for Gastric Cancer

The Claudin 18.2 test is designed to provide accurate identification of the Claudin 18.2 protein, which plays a significant role in cancer development. By accurately detecting this biomarker, the test offers oncologists valuable insights, particularly for gastric cancer patients, enabling more precise diagnoses and better treatment planning.

Gastric cancer is a leading cause of cancer-related deaths, particularly in men and women aged 15 to 44, emphasizing the need for improved diagnostic tools.

Dr Anand K, Managing Director & CEO of Agilus Diagnostics, highlighted the importance of the test in modern oncology, stating, “Claudin 18.2 is an essential biomarker in modern oncology, especially for gastric cancer patients. With an approved targeting antibody, this test not only enhances diagnostic precision but also bridges the gap to personalized medicine.”

FDA Approval of Claudin 18.2 Treatment

The launch of the Claudin 18.2 test in India aligns with recent global developments in cancer treatment. In October 2024, the U.S. Food and Drug Administration (FDA) approved zolbetuximab-clzb, an antibody targeting the Claudin 18.2 protein, in combination with chemotherapy. This therapy is now approved for the first-line treatment of adults with advanced HER2-negative gastric or gastroesophageal junction (GEJ) cancers that are Claudin 18.2-positive. The FDA also approved the VENTANA CLDN18 assay as a companion diagnostic test to identify patients eligible for this targeted therapy.

Dr Kunal Sharma, Associate Director & Head of the Histopathology Center of Excellence at Agilus Diagnostics, commented on the global implications of this development.

He said, “In October 2024, the FDA approved zolbetuximab-clzb, a Claudin 18.2-directed antibody therapy, in combination with chemotherapy, for first-line treatment of adults with advanced HER2-negative gastric or gastroesophageal junction (GEJ) cancers that are CLDN18.2-positive. The FDA also approved VENTANA CLDN18 assay as a companion diagnostic test to identify patients eligible for treatment. Agilus Diagnostics' launch of the FDA-approved Claudin 18.2 test in India aligns with these global developments, bringing advanced diagnostic and treatment opportunities to Indian oncology care.”