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Quidel Corporation QDEL, -1.44% (“Quidel”),a provider of accelerated analytic testing solutions, cellular-based virology assays and atomic analytic systems, appear today that the accomplishment of Quidel Triage [®] PLGF Assay is set to resume in 2019 and be commercially accessible alfresco the US for analytic use in Q1 2019. Knowledge of affectionate circulating absorption of Placental Advance Factor (PLGF), a biomarker for placental dysfunction, aids in the aboriginal and authentic assay of preterm pre-eclampsia and helps clinicians to accurately risk-stratify abundant women consistent in added able use of healthcare assets and the abeyant for cost-saving to the healthcare system.



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In Quidel’s accretion of the Triage [®] business from Alere Inc., affairs of the Triage PLGF product, calm with the connected accumulation of artefact into key analytic studies, transferred to Quidel. Quidel has completed an centralized assay of unmet analytic needs in the administration of pre-eclampsia and the backbone of analytic affirmation and has assured that Quidel Triage PLGF Assay is a aggressive and medically all-important analytic test.

Current antenatal apprehension of pre-eclampsia relies on analytic markers, claret burden and urinalysis for protein, which accept low acuteness and specificity, and poor anxiety ability. A low PLGF absorption in the affectionate apportionment identifies pregnancies acceptable to advance placentally-driven complications, such as preterm pre-eclampsia and fetal advance restriction. In May 2016, the UK Civic Institute for Bloom and Care Excellence (NICE) developed a civic advice for NHS England on PLGF-based testing [1] to advice clinicians analyze pre-eclampsia in women doubtable of accepting the condition. NICE recommends the use of PLGF-based tests, including Triage PLGF, to advice rule-out pre-eclampsia in abundant women who are amid 20 weeks and 34 weeks added 6 days’ evolution and accept signs or affection of pre-eclampsia.



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Uniquely, Quidel’s PLGF abstracts are performed on the Quidel Triage MeterPro, a baby bargain benchtop analyzer that enables abreast accommodating testing and provides after-effects in about 15 minutes. Quidel Triage MeterPro can affix to class advice systems and has congenital affection ascendancy features. Quidel’s MeterPro belvedere offers end-users a added cost-efficient and expedient testing belvedere than axial class analyzers.

“We are blessed to re-introduce Quidel Triage PLGF into the marketplace, thereby acceptable healthcare workers in cardinal out pre-eclampsia, and absorption our best accessible patients,” saidDouglas Bryant, admiral and arch controlling administrator ofQuidel Corporation. “Longer term, we accept that clinicians will accretion that the assay has added analytic bulk in evaluating placental health.”



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Quidel’s Triage PLGF artefact is currently CE Marked, and alone accessible for auction alfresco the United States.

[1] PLGF-based testing to advice analyze doubtable pre-eclampsia (Triage PLGF test, Elecsys immunoassay sFlt-1/PLGF ratio, DELFIA Xpress PLGF 1-2-3 test, and BRAHMS sFlt-1 Kryptor/BRAHMS PlGF added Kryptor PE ratio). Civic Institute for Bloom and Care Excellence (NICE) Diagnostics advice [DG23] Published date: May 2016.

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AboutQuidel Corporation

Quidel Corporationserves to enhance the bloom and abundance of bodies about the apple through the development of analytic solutions that can advance to bigger accommodating outcomes and accommodate bread-and-butter allowances to the healthcare system. Marketed beneath the Sofia [®] , QuickVue [®] , D3 [®] Direct Detection, Thyretain [®] , Triage [®] and InflammaDry [®] arch cast names, as able-bodied as beneath the new Solana [®] , AmpliVue [®] and Lyra [®] atomic analytic brands, Quidel’s articles aid in the apprehension and assay of abounding analytical diseases and conditions, including, amid others, influenza, respiratory syncytial virus, Strep A, herpes, pregnancy, thyroid ache and begrimed abstruse blood.Quidel’srecently acquired Triage [®] adjustment of tests comprises a absolute assay card that provides rapid, cost-effective assay decisions at the point-of-care (POC), alms a assorted immunoassay card in a array of tests to accommodate analytic answers for quantitative BNP, CK-MB, d-dimer, myoglobin, troponin I and qualitative TOX Drug Screen. Quidel’s assay and development agent is additionally developing a continuum of analytic solutions from avant-garde immunoassay to atomic analytic tests to added advance the affection of healthcare in physicians’ offices and hospital and advertence laboratories. For added advice about Quidel’s absolute artefact portfolio, appointment quidel.com.

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Forward-Looking Statements

This columnist absolution contains advanced statements aural the acceptation of the federal balance laws that absorb absolute risks, assumptions and uncertainties. Abounding accessible contest or factors could affect our approaching banking after-effects and performance, such that our absolute after-effects and achievement may alter materially from those that may be declared or adumbrated in the advanced statements. As such, no advanced account can be guaranteed. Differences in absolute after-effects and achievement may appear as a aftereffect of a cardinal of factors including, after limitation, a final assurance that some of the accoutrement of our acknowledged adjustment with Beckman Coulter are unenforceable or contrarily not valid; our assurance on sales of our affliction analytic tests; fluctuations in our operating after-effects consistent from the timing of the onset, breadth and severity of algid and flu seasons, seasonality, government and media absorption focused on affliction and the accompanying abeyant appulse on bodies from atypical affliction viruses, adverse changes in aggressive altitude in calm and all-embracing markets, the agreement adjustment currently in abode and approaching changes to that system, changes in bread-and-butter altitude in our calm and all-embracing markets, lower than advancing bazaar assimilation of our products, the abundance of our artefact in our distributors’ account or administration channels, changes in the affairs patterns of our distributors, and changes in the healthcare bazaar and alliance of our chump base; our development and aegis of proprietary technology rights; our development of new technologies, articles and markets; our assurance on a bound cardinal of key distributors; bookish acreage risks, including but not bound to, contravention litigation; our charge for added funds to accounts our basic or operating needs; the banking acumen of our barter and suppliers; accepting of our articles amid physicians and added healthcare providers; antagonism with added providers of analytic products; adverse accomplishments or delays in new artefact reviews or accompanying to currently-marketed articles by the U.S. Food and Drug Administration (the “FDA”) or added authoritative authorities or accident of any ahead accustomed authoritative approvals or clearances; changes in government policies; our acknowledgment to claims and litigation, including action currently awaiting adjoin us; costs of or our abortion to accede with government regulations in accession to FDA regulations; acquiescence with government regulations apropos to the handling, accumulator and auctioning of chancy substances; third-party agreement policies; our abortion to accede with laws and regulations apropos to announcement and acquittal for healthcare services; our adeptness to accommodated appeal for our products; interruptions in our accumulation of raw materials; artefact defects; business risks not covered by insurance; our acknowledgment to cyber-based attacks and aegis breaches; antagonism for and accident of administration and key personnel; all-embracing risks, including but not bound to, acquiescence with artefact allotment requirements, acknowledgment to bill barter fluctuations and adopted bill barter accident administration arrangements, best acquittal cycles, lower affairs prices and greater adversity in accession accounts receivable, bargain aegis of bookish acreage rights, political and bread-and-butter instability, taxes, and aberration of lower priced all-embracing articles into U.S. markets; changes in tax ante and acknowledgment to added tax liabilities or assessments; risks apropos to the accretion and affiliation of the Triage and BNP Businesses; Alere’s abortion to accomplish beneath assorted alteration agreements apropos to our accretion of the Triage and BNP Businesses; that we may acquire abundant costs to body our advice technology basement to alteration the Triage and BNP Businesses; that we may accept to address off amicableness apropos to our accretion of the Triage and BNP Businesses; that we our adeptness to administer our advance strategy; the akin of our indebtedness; the bulk of, and our adeptness to repay, renew or extend, our outstanding debt and its appulse on our operations and our adeptness to access financing; that essentially the Senior Credit Facility is anchored by essentially all of our assets; our accommodation requirements beneath the Senior Credit Facility; the agreements for our acknowledgment abode operating and banking restrictions on the Company; that an accident of absence could activate dispatch of our outstanding indebtedness; our disability to achieve conversions of our Convertible Senior Notes in cash; the aftereffect on our operating after-effects from the activate of the codicillary about-face affection of our Convertible Senior Notes; that we may acquire added indebtedness; increases in absorption amount apropos to our capricious amount debt; concoction consistent from approaching sales of our equity; animation in our banal price; accoutrement in our allotment documents, Delaware law and the acknowledgment administering our Convertible Senior Notes that ability adjournment or impede stockholder accomplishments with account to business combinations or agnate transactions; and our ambition of not advantageous dividends. Advanced statements about are articular by the use of agreement such as “may,” “will,” “should,” “might,” “expect,” “anticipate,” “estimate,” “plan,” “intend,” “goal,” “project,” “strategy,” “future,” and agnate words, although some advanced statements are bidding differently. The risks declared in letters and allotment statements that we book with theSecurities and Barter Commission(the “SEC”) from time to time, should be anxiously considered. You are cautioned not to abode disproportionate assurance on these advanced statements, which reflect management’s assay alone as of the date of this columnist release. Except as appropriate by law, we undertake no obligation to about absolution the after-effects of any afterlight or amend of these advanced statements, whether as a aftereffect of new information, approaching contest or otherwise.

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View antecedent adaptation on businesswire.com: https://www.businesswire.com/news/home/20181213005920/en/

SOURCE: Quidel Corporation

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Quidel Contact: Quidel Corporation Randy Steward Arch Banking Administrator (858) 552-7931 Media and Investors Contact: Quidel Corporation Ruben Argueta (858) 646-8023 rargueta@quidel.com

Copyright Business Wire 2018

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