Quidel Receives FDA Clearance for Its New Solana(R) Molecular Assay for the Detection of Clostridium difficile (C. difficile) Infections

SAN DIEGO, CA--(Marketwired - May 11, 2017) - Quidel Corporation (NASDAQ: QDEL), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) to market its Solana® C. difficile Assay for the direct, qualitative detection of the Clostridium difficile DNA in unformed stool specimens of patients suspected of having Clostridium difficile-infection (CDI).

Clostridium difficile is the most frequently identified enteric pathogen in patients with antibiotic-associated diarrhea and colitis. Per the Centers for Disease Control and Prevention (CDC), C. difficile was responsible for approximately half a million infections in the United States in 2011, with 29,000 patient deaths occurring shortly after the initial diagnosis.¹

Clostridium difficile bacterial infections are life threatening, especially for the elderly, for the immunocompromised, and for patients on a prolonged antibiotic regimen. Typical CDI symptoms include nausea, fever, watery diarrhea and abdominal pain due to inflammation of the colon.

Traditional methods for diagnosing CDI, such as glutamate dehydrogenase (GDH) or toxin antigen tests, can lack sensitivity and increase lab costs due to additional confirmation testing. In addition to significant technical expertise, cytotoxicity assays and toxigenic culture require 24 to 48 hours and 3 to 5 days, respectively, before reliable results can be obtained. The Solana C. difficile assay will now enable laboratories to offer a fast and sensitive result generated by molecular methods, without an upfront nucleic acid extraction step.

The Solana C. difficile Assay is an easy-to-use, accurate, molecular diagnostic test that generates an accurate result in about 35 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 different assays or patient samples in each batched run, and provides time-saving workflow advantages to healthcare professionals in moderately complex settings.

"We are excited to introduce a Solana assay that can make a profound difference in the lives of people that are affected by CDI through a quick and accurate diagnosis. The laboratorian will benefit from the Solana platform's ability to address the particular workflow needs of the moderately complex laboratory setting in a cost-effective manner by neatly balancing higher volume sample testing at scale with customizable, on-demand assay processing," said Douglas Bryant, president and chief executive officer of Quidel Corporation.

The Solana® C. difficile Assay is Quidel's first molecular diagnostic test to receive 510(k) clearance from the FDA in the scalable and versatile Solana format for diagnosis of a Healthcare Associated Infection (HAI). Other 510(k) cleared Solana molecular diagnostic assays include:

With the Solana franchise, Quidel has broadened its molecular strategy to include instrumented systems, and grown the number of its molecular platforms that are both 510(k) cleared and available commercially. Quidel's other FDA cleared molecular solutions include the AmpliVue® non-instrumented system for lower-volume moderately complex labs, and Lyra® reagents for higher throughput, highly complex laboratories that are compatible with existing PCR infrastructure.

1. https://www.cdc.gov/hai/organisms/cdiff/cdiff_infect.html

About Quidel Corporation

Quidel Corporation serves to enhance the health and well-being of people around the globe through the development of diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system. Marketed under the Sofia®, QuickVue®, D3® Direct Detection and Thyretain^® leading brand names, as well as under the new Solana®, AmpliVue® and Lyra® molecular diagnostic brands, Quidel's products aid in the detection and diagnosis of many critical diseases and conditions, including, among others, influenza, respiratory syncytial virus, Strep A, herpes, pregnancy, thyroid disease and fecal occult blood. Quidel's research and development engine is also developing a continuum of diagnostic solutions from advanced lateral-flow and direct fluorescent antibody to molecular diagnostic tests to further improve the quality of healthcare in physicians' offices and hospital and reference laboratories. For more information about Quidel's comprehensive product portfolio, visit quidel.com.

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