FDA Clearance for Quidel's Solana
News Aug 18, 2016
Quidel Corporation, has announced that it has received clearance from the United States Food and Drug Administration (FDA) to market its Solana® Trichomonas assay for the detection of nucleic acids isolated from clinician-collected vaginal swabs and female urine specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis, a sexually transmitted disease attributable to infection from the Trichomonas vaginalis parasite. The Solana® Trichomonas Assay is intended for use only with the Solana® instrument.
According to the Centers for Disease Control and Prevention (CDC), an estimated 3.7 million people in the United States have trichomoniasis. This disease is more common in women and, because only about 30% of those infected develop symptoms of trichomoniasis, most infected persons do not know that they carry the parasite. In pregnant women, Trichomonas infection is often associated with preterm delivery and low body weight in newborns. Genital inflammation is often associated with disease and can facilitate infection by other sexually transmitted pathogens, including HIV. Importantly, trichomoniasis can be cured with a single dose of antibiotics, emphasizing the need for rapid, highly sensitive tests that can detect this parasite and prompt immediate treatment.
The Solana Trichomonas assay is an easy-to-use, rapid molecular diagnostic test that has superb clinical accuracy. The assay requires no upfront extraction of DNA and generates an accurate result in approximately 30 minutes.
The Solana molecular platform leverages the Helicase-Dependent Amplification (HDA) technology that is resident in Quidel's AmpliVue® molecular product line to generate a fast and accurate test result. Solana can process up to 12 patient samples in each 30-minute run, thereby providing time-saving workflow advantages to healthcare professionals in moderately complex settings.
"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," said Douglas Bryant, president and chief executive officer of Quidel Corporation.
The Solana Trichomonas assay received CE Mark in June, and is Quidel's second molecular infectious disease diagnostic test to receive 510(k) clearance from the FDA in the scalable and versatile Solana format. Solana Group A Strep assay for the diagnosis of Group A Strep infections received 510(k) clearance from the FDA in June 2015.