March 5, 2024—Diasorin announced FDA 510(k) clearance for its Liaison Plex platform and Flex respiratory assay.
Read More »FDA clears Simplexa COVID-19, flu A/B assay
April 2023—DiaSorin has received FDA 510(k) clearance for its Simplexa COVID-19 and Flu A/B Direct assay. The test is a real-time RT-PCR assay that detects and differentiates influenza A, influenza B, and SARS-CoV-2 viruses and is performed using nasopharyngeal swab samples. Results are available in a little more than an hour on the Liaison MDX instrument.
Read More »FDA clears Simplexa Congenital CMV Direct assay
January 2023—DiaSorin announced it has received FDA 510(k) clearance for its Simplexa Congenital CMV Direct kit. The molecular diagnostic test enables direct detection of cytomegalovirus DNA in saliva swab and urine specimens from babies 21 days old or younger. It is the first kit to receive FDA clearance for CMV detection from both saliva swab and urine specimens.
Read More »FDA clears Simplexa Congenital CMV Direct assay
Nov. 11, 2022—DiaSorin announced it has received FDA 510(k) clearance for its Simplexa Congenital CMV Direct kit.
Read More »FDA clears DiaSorin Simplexa COVID-19 test
Sept. 14, 2022—DiaSorin received 510(k) clearance from the FDA for its Simplexa COVID-19 Direct kit.
Read More »FDA approves of QuantiFeron-TB Gold Plus on Liaison XS
Nov. 29, 2021—Qiagen announced that the FDA has approved the Liaison QuantiFeron-TB Gold Plus assay for use on DiaSorin’s automated Liaison XS platform.
Read More »Qiagen, DiaSorin launch Liaison LymeDetect
July 2021—Qiagen and DiaSorin launched the Liaison LymeDetect assay for markets accepting the CE mark, as an aid to detect early Lyme borreliosis infection on the DiaSorin Liaison XL and Liaison XS platforms.
Read More »DiaSorin gets EUA for Liaison SARS-COV-2 Ag
June 2021—DiaSorin received emergency use authorization from the FDA for its Liaison SARS-CoV-2 Ag.
Read More »DiaSorin acquires Luminex for $1.8 billion
April 12, 2021—DiaSorin has signed a definitive merger agreement to acquire Luminex for a total equity value of about $1.8 billion.
Read More »DiaSorin gets EUA for Liaison SARS-CoV-2 Ag
April 1, 2021—DiaSorin received emergency use authorization from the FDA for its Liaison SARS-CoV-2 Ag.
Read More »Qiagen, DiaSorin receive FDA approval for Liaison QFT-Plus
Dec. 2, 2019—Qiagen and DiaSorin announced FDA approval of the Liaison QuantiFeron-TB Plus Test developed by Qiagen and DiaSorin and the U.S. launch of an automated workflow for QFT-Plus on Liaison platforms.
Read More »DiaSorin gets FDA clearance for PCT assay
June 2018—DiaSorin received clearance from the FDA to market the Liaison Brahms PCT II Gen assay for the quantitative determination of procalcitonin.
Read More »DiaSorin gets FDA clearance for PCT assay
April 6, 2018—DiaSorin received clearance from the Food and Drug Administration to market the Liaison Brahms PCT II Gen assay for the quantitative determination of procalcitonin. “I am pleased to announce the addition of the Brahms PCT II Gen assay to our growing specialty menu in the U.S. market”, John Walter, president of DiaSorin, said in a statement. “I’m proud ...
Read More »Qiagen, DiaSorin partnership, 2/18
February 2018—Qiagen and DiaSorin announced a partnership in which Qiagen’s QuantiFeron-TB diagnostic test will be added to the menu of DiaSorin’s Liaison family of analyzers, enabling customers of both companies to process QuantiFeron-TB Gold Plus, a fourth-generation assay for latent tuberculosis detection, on Liaison platforms. QFT-Plus is the first assay from the QuantiFeron portfolio that is planned to be adapted for use on the Liaison systems, with additional assays under consideration.
Read More »DiaSorin, Beckman Coulter sign distribution partnership, 9/15
DiaSorin and Beckman Coulter Diagnostics have signed a distribution partnership agreement for the commercialization in China of DiaSorin Hepatitis B, C, and HIV tests on DiaSorin’s Liaison XL LAS connected to Beckman Coulter’s Power Express and Power Processor automated sample processing systems.
Read More »FDA clearance for parathyroid hormone assay, 7/14
July 2014—DiaSorin received FDA clearance for its Liaison N-Tact PTH Gen II immunoassay, intended for the quantitative determination of intact human parathyroid hormone in human serum and plasma samples. The kit contains 200 tests and has an open-kit shelf life of 8 weeks, meeting the needs of small- and large-volume laboratories. It also has low cross-reactivity to the 7-84 and other inactive fragments, supporting conservative patient management.
Read More »IGF-1 assay, 7/13:108
DiaSorin’s Liaison IGF-1 assay is a solution for full automation of growth factor testing on a random-access analyzer, for accurately monitoring growth dysfunctions. The company offers an extensive menu of reliable, fully automated chemiluminescent assays suitable for endocrinology clinics, reference laboratories, hospitals, and physician office laboratories. Patients benefit from rapid and accurate results, and laboratories benefit from fast turnaround time and ease of use with the Liaison assay product portfolio.
Read More »Aldosterone assay, 7/13:105
DiaSorin has received FDA clearance for its Liaison aldosterone immunoassay, which is intended for the quantitative determination of aldosterone in human serum, EDTA plasma, and urine samples. The test is used primarily for the diagnosis of hypertension.
Read More »Direct renin assay, 2/13:110
DiaSorin has received FDA clearance for its Liaison direct renin immunoassay to aid in the diagnosis and treatment of certain types of hypertension.
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