Sebia Receives FDA 510(k) Clearance for FLC Kappa and Lambda Tests

Original from: 360dx

French diagnostics firm Sebia said Thursday that it has received US Food and Drug Administration 510(k) clearance for its FLC Kappa and Lambda assays.

The immunoassays enable the quantitative detection of kappa and lambda free light chains for diagnosing and monitoring multiple myeloma and immunoglobulin light-chain amyloidosis.

According to the company, the assays have shown comparable clinical sensitivity with the Freelite assay (96.6 percent on 177 samples from patients diagnosed with MM) and improved clinical specificity (85.1 percent on 189 non-myeloma/non-amyloidosis subjects with various clinical conditions).

"As a global leader for multiple myeloma testing, Sebia expands its offer in the US with this new solution, easily adaptable to automated immunoassay instruments for a high throughput processing. The ELISA format overcomes main challenges in analytical performance often seen in alternative testing methods," Arnaud Collin, Sebia Group VP of global regulatory affairs and quality, said in a statement.

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Source: Sebia Receives FDA 510(k) Clearance for FLC Kappa and Lambda Tests