Quidel Receives FDA Clearance for Solana® Bordetella Complete® Molecular Diagnostic Assay for the Detection
of Pertussis (Whooping Cough), Parapertussis Infections
Quidel Corporation (NASDAQ: QDEL) (“Quidel”), 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 Bordetella Complete Assay, a molecular diagnostic assay to be used with the Solana
molecular diagnostic instrument for the qualitative detection and differentiation of Bordetella pertussis and Bordetella
parapertussis nucleic acids isolated from nasopharyngeal swab specimens obtained from patients suspected of having a
respiratory tract infection attributable to Bordetella pertussis and Bordetella parapertussis.
Pertussis, or whooping cough, is a very contagious disease caused by the Bordetella pertussis bacteria, which attach to
the cilia that line part of the upper respiratory tract, causing inflammation through the release of toxins, which cause airways to
swell.1 Pertussis is spread from person to person through the inhalation of bacteria from an infected person’s cough or
sneeze. Symptoms, such as a runny nose, low-grade fever, or mild cough usually develop within 5–10 days after exposure, but
sometimes appear as long as 3 weeks later. Although whooping cough can cause serious illness in children and adults, it is most
dangerous for infants and babies. According to the Centers for Disease Control and Prevention (CDC), about half of infants younger
than 1 year of age who get this disease require hospitalization.2
The incidence of pertussis has risen steadily over the last few years.3 Factors that have likely contributed to the
increased incidence of pertussis include a decline in vaccine use, waning vaccine-induced immunity in adolescent and adult
populations, failure to receive booster shots later in life, and continued circulation of B. pertussis in our
population.4-5
According to the CDC, B. parapertussis causes a pertussis-like illness that is generally milder than pertussis, likely
because the bacteria do not produce pertussis toxin. Co-infection of B. pertussis and B. parapertussis can occur but
is uncommon.6 B. parapertussis is not easily distinguished from B. pertussis infection by symptoms, and
unlike B. pertussis, usually it is not laboratory confirmed. For these reasons, the epidemiology of illness caused by B.
parapertussis is poorly recognized.7
The Solana Bordetella Complete Assay 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 on the Solana molecular diagnostic
instrument. The assay targets the IS481 and IS1001 sequence of the Bordetella pertussis and Bordetella pertussis genomes,
respectively.
The Solana molecular diagnostic instrument can process up to 12 patient samples in each batched run, and provides time-saving
workflow advantages to healthcare professionals in moderately complex settings. Solana also comes connected to Virena®, Quidel’s
data management system, which provides aggregated, de-identified testing data in near real-time.
“We are pleased to receive 510(k) clearance for our Solana Bordetella Complete Assay, as this test rounds out our Solana
molecular test offering in the respiratory category,” said Douglas Bryant, president and chief executive officer of Quidel
Corporation. “Although whooping cough cases can be sporadic, outbreaks are often highly contagious, and we believe that this test
can provide healthcare workers with the ability to quickly diagnose whooping cough and B. parapertussis. When paired with
Quidel’s Virena ecosystem, clinicians will be able to see real-time positive cases at the local level, giving them further insights
into disease prevalence for both parapertussis and pertussis.”
The Solana instrumented system offers a comprehensive set of 510(k)-cleared assays that allows laboratories to quickly process
multiple patient samples to diagnose many diseases such as Influenza A+B, Strep Complete (Groups A+C/G), RSV+hMPV, HSV 1+2/VZV,
Trichomonas, Group B Strep, and C. difficile.
The commercial introduction of Solana has broadened Quidel’s 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) http://www.cdc.gov/pertussis/about/causes-transmission.html
2) http://www.cdc.gov/pertussis/about/signs-symptoms.html
3) CDC. Provisional Pertussis Surveillance Report. 2013. http://www.cdc.gov/pertussis/downloads/pertussis-surveillance-report.pdf
4) Versteegh FGA, Schellekens JFP, Fleer A, Roord JJ. Pertussis: a concise historical review including diagnosis, incidence,
clinical manifestations and the role of treatment and vaccination in management Rev Med Microbiol 2005; 16 (3): 79-89.
5) Atwell JE, Van Otterloo J, Zipprich J, Winter K, Harriman K, Salmon DA, Halsey NA, Omer SB. Nonmedical vaccine exemptions and
pertussis in California, 2010. Pediatrics 2013; 132 (4): 624–30.
6) https://www.cdc.gov/vaccines/pubs/surv-manual/chpt10-pertussis.html
7) Mastrantonio P, Stefanelli P, Giuliano M., Herrera Rojas Y, Ciofi Degli Atti M, Anemoa A Tozzi AE. Bordetella pertussis
infection in children: epidemiology, clinical symptoms, and molecular characteristics of isolates, 1998. Journal of Clinical
Microbiology April 1998: 999-1002.
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, Thyretain®, Triage® and InflammaDry® 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 recently acquired Triage® system of tests comprises a comprehensive test menu that
provides rapid, cost-effective treatment decisions at the point-of-care (POC), offering a diverse immunoassay menu in a variety of
tests to provide healthcare providers with diagnostic answers for quantitative BNP, CK-MB, d-dimer, myoglobin, troponin I and
qualitative TOX Drug Screen. Quidel’s research and development engine is also developing a continuum of diagnostic solutions from
advanced immunoassay 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.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the federal securities laws that involve
material risks, assumptions and uncertainties. Many possible events or factors could affect our future financial results and
performance, such that our actual results and performance may differ materially from those that may be described or implied in the
forward-looking statements. As such, no forward-looking statement can be guaranteed. Differences in actual results and performance
may arise as a result of a number of factors including, without limitation, our reliance on sales of our influenza diagnostic
tests; fluctuations in our operating results resulting from the timing of the onset, length and severity of cold and flu seasons,
seasonality, government and media attention focused on influenza and the related potential impact on humans from novel influenza
viruses, adverse changes in competitive conditions in domestic and international markets, the reimbursement system currently in
place and future changes to that system, changes in economic conditions in our domestic and international markets, lower than
anticipated market penetration of our products, the quantity of our product in our distributors’ inventory or distribution
channels, changes in the buying patterns of our distributors, and changes in the healthcare market and consolidation of our
customer base; our development and protection of proprietary technology rights; our development of new technologies, products and
markets; our reliance on a limited number of key distributors; intellectual property risks, including but not limited to,
infringement litigation; our need for additional funds to finance our capital or operating needs; the financial soundness of our
customers and suppliers; acceptance of our products among physicians and other healthcare providers; competition with other
providers of diagnostic products; adverse actions or delays in new product reviews or related to currently-marketed products by the
U.S. Food and Drug Administration (the “FDA”) or other regulatory authorities or loss of any previously received regulatory
approvals or clearances; changes in government policies; our exposure to claims and litigation, including litigation currently
pending against us; costs of or our failure to comply with government regulations in addition to FDA regulations; compliance with
government regulations relating to the handling, storage and disposal of hazardous substances; third-party reimbursement policies;
our failure to comply with laws and regulations relating to billing and payment for healthcare services; our ability to meet demand
for our products; interruptions in our supply of raw materials; product defects; business risks not covered by insurance; our
exposure to cyber-based attacks and security breaches; competition for and loss of management and key personnel; international
risks, including but not limited to, compliance with product registration requirements, exposure to currency exchange fluctuations
and foreign currency exchange risk sharing arrangements, longer payment cycles, lower selling prices and greater difficulty in
collecting accounts receivable, reduced protection of intellectual property rights, political and economic instability, taxes, and
diversion of lower priced international products into U.S. markets; changes in tax rates and exposure to additional tax liabilities
or assessments; risks relating to the acquisition and integration of the Triage and BNP Businesses; Alere’s failure to perform
under various transition agreements relating to our acquisition of the Triage and BNP Businesses; that we may incur substantial
costs to build our information technology infrastructure to transition the Triage and BNP Businesses; that we may have to write off
goodwill relating to our acquisition of the Triage and BNP Businesses; that we our ability to manage our growth strategy; the level
of our indebtedness; the amount of, and our ability to repay, renew or extend, our outstanding debt and its impact on our
operations and our ability to obtain financing; that substantially the Senior Credit Facility is secured by substantially all of
our assets; our prepayment requirements under the Senior Credit Facility; the agreements for our indebtedness place operating and
financial restrictions on the Company; that an event of default could trigger acceleration of our outstanding indebtedness; our
inability to settle conversions of our Convertible Senior Notes in cash; the effect on our operating results from the trigger of
the conditional conversion feature of our Convertible Senior Notes; that we may incur additional indebtedness; increases in
interest rate relating to our variable rate debt; dilution resulting from future sales of our equity; volatility in our stock
price; provisions in our charter documents, Delaware law and the indenture governing our Convertible Senior Notes that might delay
or impede stockholder actions with respect to business combinations or similar transactions; and our intention of not paying
dividends. Forward-looking statements typically are identified by the use of terms such as “may,” “will,” “should,” “might,”
“expect,” “anticipate,” “estimate,” “plan,” “intend,” “goal,” “project,” “strategy,” “future,” and similar words, although some
forward-looking statements are expressed differently. The risks described in reports and registration statements that we file with
the Securities and Exchange Commission (the “SEC”) from time to time, should be carefully considered. You are cautioned not to
place undue reliance on these forward-looking statements, which reflect management’s analysis only as of the date of this press
release. Except as required by law, we undertake no obligation to publicly release the results of any revision or update of these
forward-looking statements, whether as a result of new information, future events or otherwise.
Quidel Contact:
Quidel Corporation
Randy Steward
Chief Financial Officer
(858) 552-7931
or
Media and Investors Contact:
Quidel Corporation
Ruben Argueta
(858) 646-8023
rargueta@quidel.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20180716005542/en/