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Medical Devices / Submissions and Approvals

Inova Diagnostics’ Assay Cleared by FDA

Aug. 16, 2018

The FDA granted clearance to Inova Diagnostics’ Quanta Flash HMGCR, a marker that helps to diagnose idiopathic inflammatory myopathy, a group of disorders that involve the inflammation of muscles used for movement.

The assay is one of thirty others cleared by the FDA for use on the Bio-Flash device, a random access chemiluminescent analyzer used in autoimmune laboratories.

Inova’s test can help distinguish between patients with self-limited myopathy who will likely recover and patients who are at severe risk of illness and often need aggressive immunosuppressive therapy.

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