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regulatory approval

It is the first time that the agency has authorized for marketing a next-generation sequencing test for HIV-1 resistance, the FDA noted.

The company said three clinical centers have validated the test in a prospective clinical trial involving more than 10,000 participants.

The company's Liaison XL Zika assay previously received Emergency Use Authorization from the FDA in 2017.

The drug is now approved as a fourth-line option for advanced, fallopian tube, or primary peritoneal cancer patients who have homologous recombination deficiency.

The nonpartisan federal agency's report suggests ways for Congress, the FDA, FTC, and CMS to expand oversight of the genetic testing market.

The assay was developed in partnership with Merck and is intended as a companion diagnostic for that firm's anti-PD-L1 immunotherapy.

The company said its APAS Independence platform can process 200 culture plates per hour and automatically remove nonsignificant plates from the workflow. 

The blood test screens individual blood donations for four common species of the parasite Babesia, which can cause anemia and other potentially fatal conditions. 

Cytek said that the approval places the company on a path to offering a complete spectral flow cytometry solution — including instruments and reagents — to customers in China.

The cancer immunotherapy regimen and companion diagnostic test will be available in Europe for patients with triple-negative breast cancer who express PD-L1. 

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