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FDA clearance

The tests by Hardy Diagnostics, Liofilchem, and Thermo Fisher Scientific, are for doctors to determine if a patient should be treated with Melinta Therapeutics' Baxdela.

The China FDA approval allows marketing of an Ortho platform consisting of fully automated blood analyzers for low-, mid-, and high-volume transfusion medicine laboratories.

The PCR-based test, run on Roche's Liat platform, was among several other assays that was cleared by the agency last month. 

Guardant is providing its Guardant 360 CDx test for a clinical trial of Merck's small molecule, c-Met kinase inhibitor called tepotinib.

Patients with PD-L1-expressing gastric or gastroesophageal junction tumors can now be identified for potential treatment with Keytruda using Agilent's assay.

The funding will be used to pay for clinical trials in the US that will be used as underlying evidence for FDA clearance of the test, the company said.

The assays are for diagnosing hepatitis B infection in individuals with acute or chronic hepatitis B, or who are recovering from hepatitis B infection.

The CDC received clearance for a number of influenza panels and kits. Agilent's assay for postnatal CNV detection, and Abbott's hematocrit test were also cleared. 

The company expects the new trials to start this fall, and plans to submit to the FDA next year to get the agency's stamp of approval.

Roche's HbA1c test, along with an immunoassay system from Shenzhen New Industries Biomedical, and a celiac test from Immco also received 510(k) clearance last month. 

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