Tag Archives: Quidel

Dec. 27, 2021—Quidel and Ortho Clinical Diagnostics have entered into a definitive agreement in which Quidel will acquire Ortho for $24.68 per share of common stock for a total consideration of about $6.0 billion.

September 2021—Quidel received the CE mark for its Savanna multiplex molecular analyzer and Savanna Respiratory Viral Panel-4 assay. Savanna is a multiplex molecular platform that enables analysis of up to 12 pathogens or targets, plus controls, from a single assay run in less than 30 minutes.

May 2021—Quidel received FDA emergency use authorization allowing the company to market its QuickVue At-Home OTC COVID-19 Test for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days, with at least 24 hours, but no more than 36 hours, between tests. This test is authorized for nonprescription home use with self-collected direct anterior nares specimens from individuals aged 14 years and older or with adult-collected anterior NS samples from individuals who are two years old or older.

April 2021—The FDA issued an emergency use authorization for the Quidel QuickVue At-Home COVID-19 test.

April 16, 2021—Quidel received FDA emergency use authorization allowing the company to market its QuickVue At-Home OTC COVID-19 Test for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days, with at least 24 hours, but no more than 36 hours, between tests.

March 2021—Quidel received emergency use authorization from the FDA to market its Solana SARS-CoV-2 assay, an isothermal reverse transcriptase­–helicase dependent amplification (RT-HDA) assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal and nasal swab specimens in viral transport media from patients suspected of having COVID-19 by their health care provider.

Dec. 29, 2020—Quidel received emergency use authorization from the FDA to market its Solana SARS-CoV-2 assay

Dec. 22, 2020 —Quidel announced it received emergency use authorization from the FDA to market its QuickVue SARS Antigen test, a point-of-care assay for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nares swab specimens from people who are suspected of COVID-19 by their health care provider within the first five days of the onset of symptoms.

September 2020—The Sofia SARS Antigen Fluorescent Immunoassay received the CE mark for use with the Sofia and Sofia 2 instruments. The CE mark allows Quidel to market and sell the Sofia SARS Antigen FIA in Europe and in countries that accept the CE mark. The test provides results in 15 minutes.

July 22, 2020—The Sofia SARS Antigen Fluorescent Immunoassay received the CE mark for use with the Sofia and Sofia 2 instruments.

June 2020—Quidel announced it has received emergency use authorization for the Lyra Direct SARS-CoV-2 Assay from the Food and Drug Administration to allow direct sample processing.

May 20, 2020—Quidel announced it has received emergency use authorization for the Lyra Direct SARS-CoV-2 Assay from the Food and Drug Administration to allow direct sample processing.

May 11, 2020—Quidel announced it has received emergency use authorization from the FDA to market its Sofia 2 SARS Antigen FIA

March 31, 2020—Quidel’s Lyra SARS-CoV-2 Assay has received expanded emergency use authorization claims from the FDA to allow testing with three additional thermocyclers: Applied Biosystems 7500 Standard, Roche LightCycler 480, and Qiagen Rotor-Gene Q.

March 18, 2020—Quidel has received emergency use authorization from the FDA to market its Lyra SARS-CoV-2 Assay, a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal or oropharyngeal swab specimens from patients suspected of COVID-19.

March 2019—Quidel has received the CE mark for its Sofia Quantitative Vitamin D FIA for use with the Sofia fluorescent immunoassay analyzer for the quantitative determination of total 25-OH vitamin D from serum samples. The test is intended for use with the Sofia analyzer to aid in the assessment of vitamin D sufficiency and is the first quantitative assay on the Sofia.

February 2019—Quidel has received the CE mark for its TriageTrue High Sensitivity Troponin I Test for the quantitative determination of troponin I in EDTA anticoagulated whole blood and plasma specimens. The test is to be used as an aid in the diagnosis of myocardial infarction for use with the company’s Triage MeterPro instrument.

September 2018—Quidel received 510(k) clearance from the FDA to market its Solana Bordetella Complete Assay, a molecular diagnostic assay for use with the Solana instrument for the qualitative detection and differentiation of Bordetella pertussis and Bordetella parapertussis nucleic acids isolated from nasopharyngeal swab specimens.

Sept. 6, 2018—Quidel has received 510(k) clearance and Clinical Laboratory Improvement Amendments waiver from the FDA to market its Sofia 2 Lyme FIA to be used with the Sofia 2 Fluorescent Immunoassay Analyzer for the rapid differential detection of human IgM and IgG antibodies to Borrelia burgdorferi from fingerstick whole blood specimens from patients suspected of B. burgdorferi infection. The test is ...

April 2018—Quidel announced it has received FDA 510(k) clearance for its CLIA-waived QuickVue Influenza A+B assay.

March 15, 2018—Quidel received 510(k) clearance from the FDA to market its Sofia Lyme FIA to be used with the Sofia 2 fluorescent immunoassay analyzer for the rapid differential detection of human IgM and IgG antibodies to Borrelia burgdorferi from serum and plasma specimens from patients suspected of B. burgdorferi infection, which causes Lyme disease. “The Sofia Lyme Assay’s 510(k) ...

March 2018—Quidel has received clearance from the FDA to market its Solana respiratory syncytial virus plus human metapneumovirus assay for the detection of nucleic acids isolated from nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection to aid in the diagnosis of RSV and/or hMPV infections.

Feb. 27, 2018—Quidel announced it has received FDA 510(k) clearance for its CLIA-waived QuickVue Influenza A+B assay. The assay allows for the rapid, qualitative detection of influenza type A and type B antigens directly in nasal swab and nasopharyngeal swab specimens from symptomatic patients in approximately 10 minutes. In a clinical study, the QuickVue Influenza A+B test was shown to ...

December 2017—Quidel received 510(k) clearance from the FDA to market its Sofia Lyme FIA for the rapid differential detection of human IgM and IgG antibodies to Borrelia burgdorferi from serum and plasma specimens from patients suspected of B. burgdorferi infection. The test is intended for use with the Sofia analyzer to aid in the diagnosis of Lyme disease.

October 2017—Quidel announced a revised definitive agreement with Alere for its pending acquisition of Alere’s B-type Natriuretic Peptide assay business run on Beckman Coulter analyzers under which post-acquisition, Quidel will undertake direct commercial responsibility for all BNP sales worldwide.

August 2017—Quidel received 510(k) clearance to market its Solana C. difficile Assay for the direct, qualitative detection of Clostridium difficile DNA in unformed stool specimens of patients suspected of having Clostridium difficile infection.

February 2017—Quidel has received 510(k) clearance from the Food and Drug Administration to market its Solana Strep Complete Assay for the rapid and qualitative detection and differentiation of Streptococcus pyogenes (group A beta-hemolytic streptococcus) and Streptococcus dysgalactiae (pyogenic group C and G beta-hemolytic streptococcus) nucleic acids isolated from throat swab specimens obtained from symptomatic patients.

March 2016—Quidel has received the CE mark for its Sofia S. pneumoniae fluorescent immunoassay for use with the Sofia Fluorescent Immunoassay Analyzer. The Sofia S. pneumoniae FIA enables the qualitative detection of Streptococcus pneumoniae antigen in the urine of patients with pneumonia and in the cerebral spinal fluid of patients with meningitis in 10 minutes.

December 2013—Quidel and Life Technologies announced that the FDA has granted 510(k) clearances to the Quidel Molecular Influenza A+B assay and the Quidel Molecular RSV+hMPV assay, both for use on the QuantStudio Dx Real-Time PCR instrument by Life Technologies.

Quidel Corp. has completed its acquisition of BioHelix Corp. According to terms of the deal, Quidel will pay BioHelix shareholders $10 million in cash, plus additional amounts in connection with an R&D earn-out based on the completion of a designated number of assays and a commercial earn-out dependent on product sales over a defined period.

Quidel has received FDA 510(k) clearance for its Molecular RSV and hMPV assay for the detection of respiratory syncytial virus and human metapneumovirus. The assay distinguishes between RSV and hMPV. The RSV and hMPV assay can be batched alongside other Quidel Molecular assays, such as the influenza A and B PCR assay, in the same multiwell panel for customized multiplexing capability.