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Quidel’s Solana Trichomonas assay gets FDA approval

MDBR Staff Writer Published 18 August 2016

Rapid diagnostic testing solutions provider Quidel has secured approval from the US Food and Drug Administration (FDA) for its Solana Trichomonas assay.

The new assay has been developed to detect nucleic acids isolated from clinician-collected vaginal swabs and female urine specimens received from symptomatic or asymptomatic females to diagnose trichomoniasis.

Trichomoniasis is a sexually transmitted disease, which is caused by Trichomonas vaginalis parasite.

The rapid molecular diagnostic test, which requires no upfront extraction of DNA, can generate an accurate result in around 30 minutes, the company said.

Solana molecular platform is based on the Helicase-Dependent Amplification (HDA) technology, which is part of the firm’s AmpliVue molecular product line.

Solana test enables healthcare professionals to process around 12 patient samples in each 30-minute run.

In June, the company secured CE mark approval for the Solana Trichomonas assay.

Last year, the company also received 510(k) clearance from the FDA for its Solana Group A Strep assay to diagnose Group A Strep infections.

Quidel president and CEO Douglas Bryant said: "We are pleased to receive clearance for our Solana Trichomoniasis assay, as it has shown excellent performance with vaginal swab and urine samples from both symptomatic and asymptomatic patients.

“We believe that our test can play a vital role in quickly diagnosing this disease in the moderately complex setting, thereby creating opportunities for patient treatment and limiting its spread.”

As per the Centers for Disease Control and Prevention (CDC), around 3.7 million people have been infected with trichomoniasis in the US.