The BGM Galectin-3 blood test is the first novel cardiovascular in-vitro diagnostic to be cleared by the FDA in >5 years. It marks the first clinical application derived from the galectin-3 research and the first blood test indicating the prognosis of patients diagnosed with chronic heart failure that is due to underlying fibrosis resulting in adverse outcomes.
Elevated galectin-3 levels identify a subset of patients with chronic heart failure who suffer from an inherently progressive form of heart failure due to galectin-3-mediated fibrosis and adverse remodeling. Galectin-3 testing is indicated for use in patients previously diagnosed with chronic heart failure and cannot be used to diagnose heart failure.
The BGM Galectin-3 blood test is based on the common ELISA format, using the standard microtiter plate presentation.
Interpreting Galectin-3 Results*
Galectin-3 results should be interpreted in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure.
- Patients with chronic heart failure with galectin-3 levels over 17.8 ng/mL were found to have a higher risk of adverse outcomes, including mortality or hospitalization, compared to patients with levels below 17.8 ng/mL.1
- Galectin-3 levels between 17.8 ng/mL and 25.9 ng/mL should be interpreted with caution because these values lie within the reference range.1
Interpretation Relative to Natriuretic Peptides*
Galectin-3 differs markedly from natriuretic peptides. Galectin-3 and natriuretic peptides are measures of separate and distinct biological processes. Each marker provides independent and complementary information on the prognosis of patients with chronic heart failure.
When interpreting galectin-3 results, it is important to note that:
- Galectin-3 levels are not affected by decompensation; they reflect the presence or absence of an underlying disease process.2,3
- The BGM Galectin-3 blood test is only indicated for use in patients with chronic heart failure.1
- Once elevated, galectin-3 levels are generally very stable over time.2,3
- Galectin-3 values should not be used to monitor pharmacologic therapies used in the treatment of heart failure.1,3
- As with other laboratory tests, galectin-3 is subject to certain limitations.1,3 (See Limitations below.)
When reviewing published articles about galectin-3, it is important to note which assay was used in the investigation. Results obtained with research-use-only assays cannot be compared to those obtained with the BGM Galectin-3 assay. Additionally, investigators may have used cut-points different from the 17.8 ng/mL and 25.9 ng/mL in the analysis. These alternative cut-points have not been investigated for clinical use and are not recommended.
Levels of galectin-3 in blood may be increased in patients with certain forms of advanced cancer and other conditions associated with organ fibrosis. Galectin-3 results should be interpreted with caution in such patients.
The BGM Galectin-3 ELISA is subject to certain interferences commonly found with similar products. For example, presence of human anti-mouse antibodies (HAMA) or rheumatoid factor (RF) may interfere with the galectin-3 assay, which could cause falsely elevated results. The BGM Galectin-3 assay should not be used in patients with known HAMA or RF. Galectin-3 results should be interpreted with caution in patients with a history of therapeutic use of murine monoclonal antibodies (IgG) or their fragments, or who have known autoimmune disorders.
Additionally, specimens with high levels of gamma globulins (>2.5 g/dL) may cause false elevation in results. Galectin-3 results from patients with diseases associated with hypergammaglobulinemia, such as multiple myeloma, should be interpreted with caution.
For further details on possible interferences and other limitations of the BGM Galectin-3 assay, please see the Package Insert.
Ordering & Customer Service
A 96-well plate will accommodate approximately 38 galectin-3 measurements conducted in duplicate. To place an order, for order status or for non-technical questions, call 1-877-665-0077 or email email@example.com.
This test should only be performed at clinical laboratories certified to perform such tests and by trained laboratory staff familiar with this complexity of assays.
BG Medicine is committed to offering the highest quality of service. For technical information, technical questions and feedback on our service and products, call 1-877-665-0077 or email firstname.lastname@example.org.
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* Refer to the BGM Galectin-3 Package Insert for complete information. The BGM Galectin-3 test is not yet available for sale or distribution in Canada.
- Galectin-3 Product Insert (US), BG Medicine, Inc., March 2011
- de Boer RA, Lok DJ, Jaarsma T, et al. Predictive value of plasma galectin-3 levels in heart failure with reduced and preserved ejection fraction. Ann Med 2011;43:60–8.
- McCullough P, Olobatoke A, Vanhecke TE. Galectin-3: a novel blood test for the evaluation and management of patients with heart failure. Rev Cardiovasc Med. 2011;12:200–10.