New Blood Test for Esophageal Cancer Achieves 94% Accuracy, Set to Launch in 2025
September 24, 2024Proteomics International Laboratories has developed a promising blood test called Promarker Eso, which achieved an impressive 94% accuracy in detecting esophageal adenocarcinoma (EAC) during a clinical validation study involving 165 samples.
The results of this test were officially presented at the International Society for Diseases of the Esophagus World Congress in Edinburgh, garnering recognition from peers in the medical field.
The clinical validation study included 66 confirmed AEC cases and 99 healthy controls, demonstrating both high sensitivity and specificity for the test.
Promarker Eso aims to significantly reduce the reliance on invasive endoscopies, which are costly and often miss a large percentage of AEC cases.
Dr. Richard Lipscombe, managing director of Proteomics, emphasized the test's potential to improve early detection and reduce the economic burden associated with late-stage esophageal cancer.
The test utilizes a mass spectrometry-based workflow to evaluate levels of four glycoproteins, along with a patient's age and BMI, to generate a risk score that advises high-risk patients to undergo endoscopy.
Plans are underway to launch Promarker Eso in Australia in the first quarter of 2025, with intentions to expand to other markets, including the US.
In the US, Proteomics will utilize the laboratory-developed test pathway to launch Promarker Eso, bypassing the need for full FDA approval.
The test has already secured patents in Europe, China, and Australia, with additional applications pending in other regions.
Esophageal cancer remains a significant health concern, being the sixth leading cause of cancer-related deaths globally, with a five-year survival rate of only 20%.
The refined Promarker Eso test was also reassessed on a cohort from Ochsner in the US, confirming its diagnostic accuracy.
Overall, the clinical validation study analyzed nearly 300 samples across three patient groups, further solidifying the test's reliability.
Summary based on 3 sources
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Sources
The Sydney Morning Herald • Sep 23, 2024
Proteomics lands blow on deadly esophageal cancerMedical Device Network • Sep 23, 2024
Proteomics reports positive results for PromarkerEso oesophageal cancer test