Skip to main content
Premium Trial:

Request an Annual Quote

BG Medicine Files 510(k) for Automated Galectin-3 Test on Abbot Architect Platform


BG Medicine said last week that it filed a 510(k) submission with the US Food & Drug Administration for an automated version of its BGM Galectin-3 heart failure test to be run on Abbott Laboratories' Architect platform.

If it receives clearance, the new assay would be the first galectin-3 test on an automated platform and would represent a significant milestone for BG Medicine, which has maintained that moving its galectin-3 assay to an automated format is key to driving commercialization of the test.

"Subject to clearance by the FDA, the automated test would enable broader access and more timely information flow to physicians and their patients," BG Medicine CEO Eric Bouvier said in a statement.

A manual version of the test received US Food and Drug Administration clearance in 2010 and is marketed by Laboratory Corporation of America and Mayo Medical Laboratories. Automated versions of the test are being developed by Abbott, Alere, Siemens, and BioMérieux.

The company announced in May that it has obtained a CE mark and filed a 510(k) submission for an expanded use of the galectin-3 test (PM 5/17/2012). Currently the test is approved for monitoring patients with chronic heart failure. The new application would expand use to the general adult population for identification of people with an increased risk of heart failure.

According to Bouvier, this expanded indication would have a potential market of roughly 200 million people in the US and Europe, compared to around 20 million for its current use.

The Scan

Fertility Fraud Found

Consumer genetic testing has uncovered cases of fertility fraud that are leading to lawsuits, according to USA Today.

Ties Between Vigorous Exercise, ALS in Genetically At-Risk People

Regular strenuous exercise could contribute to motor neuron disease development among those already at genetic risk, Sky News reports.

Test Warning

The Guardian writes that the US regulators have warned against using a rapid COVID-19 test that is a key part of mass testing in the UK.

Science Papers Examine Feedback Mechanism Affecting Xist, Continuous Health Monitoring for Precision Medicine

In Science this week: analysis of cis confinement of the X-inactive specific transcript, and more.