Tag Archives: Qiagen

February 2024—Qiagen announced FDA clearance of the NeuMoDx CT/NG assay 2.0 for its NeuMoDx 96 and 288 integrated PCR-based clinical molecular testing systems in the United States. The assay is designed for direct detection of asymptomatic and symptomatic bacterial infections for Chlamydia trachomatis and Neisseria gonorrhoeae. Results are delivered in about an hour.

November 2023—Qiagen announced FDA approval of its Therascreen PDGFRA RGQ PCR kit, a companion diagnostic intended for use to aid clinicians in identifying patients with gastrointestinal stromal tumors (GIST) who may be eligible for treatment with avapritinib (Ayvakit, Blueprint Medicines). Ayvakit is approved in the United States for the treatment of adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations. Qiagen says its kit is the first PDGFRA assay to receive FDA approval as a companion diagnostic.

August 2023—Qiagen announced that the U.S. Federal Bureau of Investigation has approved its ForenSeq Mainstay workflow, allowing accredited forensic DNA laboratories to process DNA casework samples and search resulting profiles against the U.S. National DNA Index System CODIS database. The ForenSeq Mainstay workflow is composed of the high-throughput Verogen ForenSeq Mainstay kit, MiSeq FGx next-generation sequencing system, and ForenSeq Mainstay analysis module in the Universal Analysis software.

July 2023—Qiagen announced that its variant interpretation and reporting software, Qiagen Clinical Insight (QCI) Interpret, was chosen by the Danish National Genome Center to provide interpretation of oncology results generated from whole genome sequencing data. The initiative is part of a larger personalized medicine strategy that aims to provide WGS as the standard of care for relevant patient groups throughout Denmark.

June 26, 2023—Qiagen announced that its variant interpretation and reporting software, Qiagen Clinical Insight (QCI) Interpret, was chosen by the Danish National Genome Center to provide interpretation of oncology results generated from whole genome sequencing data.

June 19, 2023—Qiagen announced the publication of a study that aimed to compare and analyze the difference in interferon-gamma (IFN-γ) production between QuantiFeron-TB Gold Plus TB1 and TB2 blood collection tubes in general and specific populations (Darmawan G, et al. Clin Chem Lab Med. Published online May 25, 2023. doi:10.1515/cclm-2023-0293)

April 2023—Qiagen has entered into a strategic partnership with Servier to develop a companion diagnostic test for Tibsovo (ivosidenib), an isocitrate dehydrogenase-1 inhibitor indicated for the treatment of acute myeloid leukemia. Under the agreement, Qiagen will develop and validate a real-time in vitro PCR test that can be used to detect IDH1 gene mutations in patients with AML in whole blood and bone marrow aspirates. The companion diagnostic will run on Qiagen’s Rotor-Gene Q MDx instrument.  

March 2023—Qiagen has launched its QIAseq Platform Partnership program and a partnership with Sophia Genetics that will bring together QIAseq reagent technology for next-generation sequencing with the Sophia DDM digital analytics platform. The Platform Partnership program aims to enhance the use and compatibility of QIAseq NGS kits to support secondary analysis and tertiary interpretation workflows offered by other digital data-sharing and analytics companies. The kits are designed for use with any sequencer.  

February 2023—Qiagen announced an exclusive strategic partnership with Helix to advance companion diagnostics for hereditary diseases. Under the agreement, Qiagen will be the exclusive marketing and contracting partner in the United States for Helix’s companion diagnostic services.  

February 2022—Qiagen has launched its EZ2 Connect MDx for use in diagnostic laboratories. The platform enables labs to purify DNA and RNA from up to 24 samples at the same time in as few as 30 minutes and uses magnetic-bead technology to extract nucleic acids from blood plasma, serum, stool, and other sample types. The benchtop instrument automatically pierces sealed cartridges, heats samples for incubation, and automates pipetting of beads, buffers, and enzymes. It can be used in research or IVD mode and monitored and managed remotely using the QIAsphere app.  

March 1, 2023—Qiagen has launched its QIAseq Platform Partnership program and a partnership with Sophia Genetics that will bring together QIAseq reagent technology for next-generation sequencing with the Sophia DDM digital analytics platform.

Jan. 19, 2023—Qiagen has launched its EZ2 Connect MDx for use in diagnostic laboratories.

Jan. 6, 2023—Qiagen announced an exclusive strategic partnership with Helix to advance companion diagnostics for hereditary diseases.

Dec. 14, 2022—Qiagen announced FDA approval of its Therascreen KRAS RGQ PCR kit as a companion diagnostic test to aid in identifying non-small cell lung cancer patients eligible for treatment with adagrasib (Krazati, Mirati Therapeutics).

April 2022—Qiagen announced test enhancements to its QIAstat-Dx, a fully integrated molecular diagnostic testing solution with one-step sample processing that provides results in about one hour. The company is awaiting U.S. regulatory approval of a gastrointestinal panel designed to detect 22 common viral, bacterial, and parasitic pathogens that can cause potentially life-threatening infections. Qiagen has also registered for CE marking a meningitis/encephalitis panel designed to analyze 15 pathogens simultaneously and help distinguish between meningitis and encephalitis.

March 2022—Qiagen announced expansion initiatives for its QuantiFeron portfolio, including developing new applications for technology designed to detect potentially deadly latent diseases. Among the company’s recent developments are the CE marking of its QuantiFeron SARS-CoV-2 assay, which launched in December 2021; the FDA’s expansion of the range of target groups that can be tested with the blood-based QuantiFeron-TB Gold assay, which now includes people with weakened immune systems, pregnant women, and children; and the Global Fund’s expert review panel for diagnostics’ approval of the QIAreach QuantiFeron-TB test, which means the test may now be procured by public health programs and institutions in more than 100 countries that qualify for Global Fund and Unitaid resources, as well as made available through the Stop TB Partnership’s Global Drug Facility.

February 2022—Qiagen and Denovo Biopharma will collaborate to develop a blood-based companion diagnostic test to identify patients expressing Denovo Genomic Marker 1 (DGM1) who are likely to respond to Denovo’s investigational cancer drug DB102 for treatment of diffuse large B-cell lymphoma. DB102 (enzastaurin) is an investigational small molecule inhibitor of PKC-beta, which, if present, has been linked to DLBCL cases.

December 2021—Qiagen announced that the FDA has approved the Liaison QuantiFeron-TB Gold Plus assay for use on DiaSorin’s automated Liaison XS platform. The Liaison QuantiFeron-TB Gold Plus tests for interferon gamma released from T cells that have encountered TB. The assay was developed by Qiagen and DiaSorin to offer streamlined laboratory automation for latent TB screening.

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.

September 2021—Qiagen announced a commercialization partnership with Verogen that will provide customers with tools and comprehensive support for human identification workflows in laboratories.

September 2021—Qiagen’s NeuMoDx HAdV Quant Assay for the identification and quantification of human adenovirus DNA has received CE-IVD certification for the European Union and other countries that accept this mark. The tests can be run in true random access along with laboratory-developed tests.

August 2021—Qiagen launched its Artus SARS-CoV-2 Prep&Amp UM Kit, which integrates a liquid-based sample preparation technology for COVID-19 testing that takes two minutes or less with the provided real-time PCR assay. The kit uses common transport media as the starting material and provides all reagents required for sample to result on suspected SARS-CoV-2 patient samples. The workflow can support up to 672 samples per cycler in an eight-hour shift.

Aug. 6, 2021—Qiagen received emergency use authorization from the FDA for its QIAreach SARS CoV-2 Antigen Test.

July 2021—Qiagen and Inovio Pharmaceuticals announced an extension of their partnership with a new agreement to develop liquid-biopsy–based companion diagnostic products based on next-generation sequencing technology to complement Inovio’s therapies.

July 2021—Qiagen announced FDA emergency use authorization for the NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay, to help identify and differentiate people suspected of respiratory viral infection consistent with COVID-19.

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.

June 2021—Qiagen received emergency use authorization for its QIAreach Anti-SARS-CoV-2 Total Test, a digital assay to detect total SARS-CoV-2 antibodies (IgA, IgG, IgM).

June 7, 2021—Amgen announced that the FDA approved Lumakras (sotorasib) for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer, as determined by an FDA-approved test, who have received at least one prior systemic therapy.

May 2021—Qiagen announced the global launch of the CE-IVD-marked QIAcube Connect MDx, a flexible platform for automated sample processing available now to molecular diagnostic laboratories in the U.S., Canada, the European Union, and other markets worldwide.

May 17, 2021—Qiagen received emergency use authorization for its QIAreach Anti-SARS-CoV-2 Total Test, a digital assay to detect total SARS-CoV-2 antibodies (IgA, IgG, IgM).

April 2021—Qiagen launched its QIAsphere cloud-based platform, which will allow labs and QIAstat-Dx users to monitor tests and instrument status remotely 24 hours a day, 7 days a week.

March 31, 2021— Qiagen announced FDA emergency use authorization for the NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay, to help identify people suspected of respiratory viral infection consistent with COVID-19.

March 22, 2021—Qiagen launched its QIAsphere cloud-based platform that will allow labs and QIAstat-Dx users to monitor tests and instrument status remotely 24 hours a day, seven days a week.

March 10, 2021—Qiagen and Inovio Pharmaceuticals announced an extension of their partnership with a new agreement to develop liquid-biopsy-based companion diagnostic products based on next-generation sequencing technology to complement Inovio’s therapies.

March 4, 2021—Qiagen announced the global launch of the CE-IVD-marked QIAcube Connect MDx, a flexible platform for automated sample processing available now to molecular diagnostic laboratories in the U.S., Canada, the European Union, and other markets worldwide.

February 2021—Qiagen announced that it now retains the exclusive rights to license and distribute the COSMIC database from the Wellcome Sanger Institute for commercial use, effective Jan. 1. COSMIC, the Catalogue of Somatic Mutations in Cancer, is a large, comprehensive resource for exploring the impact of somatic mutations in human cancer. The database is updated continuously and contains more than 37 million coding mutations. More than 20,000 researchers, bioinformaticians, and clinicians worldwide use COSMIC, which is available for download, annotation, and integration.

Jan. 22, 2021—Tecan has launched the Fluent Mix and Pierce Workstation to provide end-to-end automation for whole blood pipetting in clinical environments.

January 2021—Qiagen has acquired the remaining 80.1 percent of NeuMoDx Molecular for $248 million in cash. The company purchased a 19.9 percent stake in NeuMoDx in 2018, along with the right to acquire the remaining stake. As part of the 2018 deal, Qiagen has distributed the NeuMoDx 288 and NeuMoDx 96 platforms in Europe and other markets outside the United States.

Jan. 13, 2021–Qiagen announced that it now retains the exclusive rights to license and distribute the COSMIC database from the Wellcome Sanger Institute for commercial use, effective Jan. 1.

December 2020—Qiagen announced the European launch of the NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test, which aims to help health care professionals identify and differentiate between patients with common seasonal respiratory infections and COVID-19. The multiplex PCR test detects and differentiates influenzas A and B, respiratory syncytial virus, and SARS-CoV-2 infections within 80 minutes.

November 2020—Qiagen plans to launch a test that can detect SARS-CoV-2 antigens in people with active infections in less than 15 minutes and process, on average, 30 swab samples per hour using a small digital detection system. The test is expected to become available in the fourth quarter of this year.

Nov. 17, 2020—Qiagen announced the European launch of the NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage test, which aims to help health care professionals identify and differentiate between patients with common seasonal respiratory infections and COVID-19.

Sept. 22, 2020—Qiagen has acquired the remaining 80.1 percent of NeuMoDx Molecular for $248 million in cash.

September 2020—Qiagen has launched the QIAseq SARS-CoV-2 Primer Panel for next-generation sequencing of the novel coronavirus genome and integrated analysis and interpretation workflows for insights into the evolution and spread of the virus.

Aug. 25, 2020—Qiagen has launched the QIAseq SARS-CoV-2 Primer Panel for next-generation sequencing of the novel coronavirus genome and integrated analysis and interpretation workflows for insights into the evolution and spread of the virus.

Aug. 18, 2020—Qiagen is offering a four-part web seminar series in which the latest tips and tricks for successful biomarker profiling from FFPE samples will be discussed.

April 16, 2020—Qiagen launched its novel Therascreen BRAF V600E RGQ PCR Kit following FDA approval of the kit as a companion diagnostic to the BRAF inhibitor Braftovi (encorafenib).

April 1, 2020—Qiagen has received emergency use authorization from the FDA for its QIAstat-Dx Respiratory SARS-CoV-2 Panel test for use in diagnosing patients infected with the novel COVID-19 coronavirus.

March 24, 2020—Qiagen has started shipping its QIAstat-Dx Respiratory SARS-CoV-2 Panel test to the United States under an FDA policy announced on March 16. Qiagen will submit this week the related emergency use authorization to the FDA.

March 2020—Qiagen announced the CE marking and launch of its Therascreen PIK3CA RGQ PCR Kit in Europe as an aid in identifying breast cancer patients with a PIK3CA mutation. The Therascreen PIK3CA test was approved in 2019 by the FDA and launched in the U.S. as a companion diagnostic test for Piqray (alpelisib).

March 18, 2020—Qiagen has obtained the CE mark for its newly developed QIAstat-Dx Respiratory SARS-CoV-2 Panel test to be sold as an in vitro diagnostic for the detection of SARS-CoV-2. The QIAstat-Dx test kit can differentiate the SARS-CoV-2 coronavirus from 21 other serious respiratory infections in patients who may have similar symptoms in a single testing run of about one hour.

March 5, 2020—Thermo Fisher Scientific will acquire Qiagen, the companies announced on March 3.

Feb. 27, 2020—Qiagen announced it has shipped its newly developed QIAstat-Dx Respiratory Panel 2019-nCoV test kit to four hospitals in China for evaluation and is in the process of shipping QIAstat-Dx testing kits to public health institutions in other regions, including Europe, Southeast Asia, and the Middle East.

Feb. 21, 2020—Qiagen announced the CE marking and launch of its Therascreen PIK3CA RGQ PCR Kit in Europe as an aid in identifying breast cancer patients with a PIK3CA mutation. The Therascreen PIK3CA test was approved in 2019 by the FDA and launched as a companion diagnostic test for Piqray (alpelisib) in the U.S.

February 2020—Qiagen introduced QIAseq Multimodal Panels, which offer a consolidated workflow to enrich DNA variants, RNA fusions, and gene expression levels from a single sample, with input as low as 10 ng of total nucleic acid. It reduces the workflow to approximately nine hours, the company reports, by eliminating the need for two workflows from separate DNA and RNA samples.

January 2020—Qiagen announced a series of agreements that expand its immuno-oncology assets for future commercialization of novel companion diagnostics, in particular based on next-generation sequencing technology. The agreements include a collaboration with Tokyo-based Repertoire Genesis that will provide access to novel technologies for the development of T-cell/B-cell receptor repertoire assays for use on NGS systems.

January 2020—Qiagen’s QuantiFeron-TB Gold Plus has been added to the diagnostic catalog of the Stop TB Partnership’s Global Drug Facility. The GDF provides quality-assured tuberculosis medicines, diagnostics, and laboratory supplies to the public sector.

December 2019—Qiagen announced the publication of a multicenter clinical study demonstrating the accuracy of its QIAstat-Dx syndromic testing solution for diagnosing the causes of acute gastroenteritis. The study evaluated 385 patient samples at university hospital laboratories across Europe and showed the QIAstat-Dx Gastrointestinal Panel was highly sensitive (98.2 percent positive) and specific (99.9 percent negative). Multiple pathogens were identified in nearly one-third of the patient samples that tested positive. The study also cited the ability of the panel to provide cycle threshold values and amplification curves to aid in interpreting results.

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.

November 2019—Qiagen launched its QIAseq Expanded Carrier Screening Panel, which provides identification of targets, genes, and other regions of interest responsible for more than 200 disease indications. The QIAseq panel is integrated with the company’s CLC Genomics Workbench and Clinical Insight (QCI)-Interpret for QIAseq to provide evidence-based, actionable insights.

Nov. 7, 2019—Qiagen introduced its QIAseq Multimodal Panels, which offer a consolidated workflow to simultaneously enrich DNA variants, RNA fusions, and gene expression levels from a single sample, with input as low as 10 ng of total nucleic acid.

Oct. 9, 2019—Illumina and Qiagen announced a 15-year partnership intended to broaden the availability and use of NGS-based in vitro diagnostic kits, including companion diagnostics, for patient management.

August 2019—Qiagen and Inovio Pharmaceuticals will collaborate to co-develop a companion diagnostic to guide clinical decision-making for the use of Inovio’s DNA-based immunotherapy to treat cervical dysplasia caused by human papillomavirus. The partnership focuses on Inovio’s VGX-3100

June 3, 2019—Qiagen announced the launch of its Therascreen PIK3CA RGQ PCR Kit after it received U.S. regulatory approval as a companion diagnostic to aid in identifying breast cancer patients eligible for treatment with Piqray (alpelisib, Novartis), which was co-approved by the FDA.

May 22, 2019—Qiagen has launched its QIAstat-Dx (formerly Stat-Dx DiagCore) syndromic testing system after receiving 510(k) clearance from the Food and Drug Administration.

May 2019—Qiagen introduced its exoRNeasy Midi and Maxi kits for isolation of exosomes and other extracellular vesicles from urine and other samples and its miRNeasy 96 Advanced QIAcube HT Kit for automated purification of total RNA, including miRNA, from serum and plasma samples.

April 2019—Qiagen and Tecan Group announced a collaboration to improve the processing of Qiagen’s QuantiFeron-TB Gold Plus diagnostic test. The companies are working together to optimize a solution that standardizes and automates the manual steps in liquid handling for the aliquoting of samples.

April 17, 2019—Qiagen announced the U.S. launch of its Therascreen FGFR RGQ RT-PCR Kit as a companion diagnostic to help guide the use of the FGFR kinase inhibitor Balversa (erdafitinib; Janssen Biotech). The test will aid in identifying patients with urothelial cancer whose tumors have certain alterations in the fibroblast growth factor receptor 3 gene. The FDA co-approved the test with Balversa.

March 2019—Qiagen released a bioinformatics analysis tool designed to bring the company’s sequencing analysis solutions to biologists who do not have a primary focus on bioinformatics.

March 2019—The Japanese Pharmaceuticals and Medical Device Agency has approved Qiagen’s Therascreen EGFR RGQ PCR Kit for use as a companion diagnostic with Pfizer’s Vizimpro (dacomitinib) for EGFR gene mutation-positive, inoperable or recurrent non-small cell lung cancer.

February 2019—Qiagen launched the QIAcube Connect, the next generation of the QIAcube instrument. QIAcube Connect fully automates the lysis, bind, wash, and elute steps of the Qiagen spin columns (which can also be used manually) for DNA, RNA, and protein sample processing. It is compatible with a range of the company’s sample technologies and can be used to automate more than 80 Qiagen kits with more than 3,000 proven protocols.

February 2019—Digital pathology RFPs: from the questions to selections: To those who request the information and those who supply the information, requests for proposal, better known as RFPs, can be groanworthy. Yet laboratories planning to purchase a digital pathology system for clinical use should seriously consider going through the painstaking process, even if their institutions don’t require it, says Liron Pantanowitz, MD, vice chair of pathology informatics at the University of Pittsburgh Medical Center.

January 2019—Qiagen launched its QIAscreen HPV PCR Test, a CE-marked in vitro molecular diagnostic test for the detection of 15 recognized high-risk genotypes of human papillomavirus. Validated sample types include cervical specimens collected in PreservCyt, Pathtezt, and Surepath collection medium, as well as self-collected vaginal brush specimens collected and shipped dry or in saline or self-collected cervico-vaginal lavage specimens.

December 2018—Qiagen announced the worldwide launch of the QIAamp PowerFecal Pro DNA Kit, for the extraction of high-quality DNA from fecal and gut samples.

December 2018—Qiagen launched its QIAseq FastSelect RNA Removal Kit, which allows rapid selective removal of RNA classes from any sample, enabling researchers to attain high-quality, reproducible RNA sequencing results.

Dec. 7, 2018—Qiagen launched two novel products to deliver actionable insights on a wide range of blood cancers: a workflow for the Qiagen Clinical Insight Interpret bioinformatics solution for hematological malignancies, and the QIAact Myeloid DNA UMI Panel for use in myeloid neoplasm research using the company’s GeneReader NGS System. The QIAact myeloid panel provides an integrated sample-to-insight workflow targeting ...

November 2018—Qiagen has introduced an automated, CE-marked workflow for its Quanti-Feron-TB Gold Plus Blood Collection Tubes and a novel DiaSorin Liaison Test on DiaSorin’s Liaison systems. The launch offers Liaison customers high-throughput detection with QFT-Plus as part of the system’s broad menu, and QFT-Plus users will gain an option for full automation of laboratory handling to support TB control efforts. Customers using the new latent TB detection workflow for Liaison systems will purchase the detec-tion components from DiaSorin and the blood collection tube kits from Qiagen. The test is available in Europe and other markets, with an expected U.S. release in 2019 and in China in 2020. In a separate release, Qiagen and NeuMoDx Molecular announced a strategic partnership to commercialize two fully integrated systems for automation of PCR test-ing. Under the agreement, Qiagen will initially distribute the NeuMoDx 288 (for high throughput) and NeuMoDx 96 (for mid-throughput) in Europe and other markets outside of the United States; NeuMoDx will cover the U.S.

November 2018—Qiagen and Hamilton Robotics announced a collaboration to improve processing of Qiagen’s QuantiFeron-TB Gold Plus diagnostic test through the integration of Hamilton’s Microlab Star automated liquid handling workstation into the QFT-Plus assay workflow.

October 2018—Qiagen announced a collaboration with SRL, a large clinical testing laboratory company in Japan, to prepare for introducing new companion diagnostics simultaneously with new drug approvals. The nonexclusive master collaboration agreement for clinical laboratory research services will enable rapid implementation by SRL of Qiagen’s companion diagnostic workflows upon approval of the drugs and tests by Japan’s Pharmaceuticals and Medical Devices Agency.

Oct. 15, 2018—Qiagen launched its QIAseq FastSelect RNA Removal Kit, which allows rapid selective removal of RNA classes from any sample, enabling researchers to attain high quality, reproducible RNA sequencing results.

Oct. 8, 2018—Qiagen announced the worldwide launch of the QIAamp PowerFecal Pro DNA Kit, for the extraction of high-quality DNA from fecal and gut samples.

Oct. 1, 2018—Qiagen announced that the FDA has approved a PMA supplement expanding the labeling claim of the Therascreen EGFR RGQ PCR Kit to allow its use as a companion diagnostic with Pfizer’s Vizimpro (dacomitinib) for first-line treatment of patients with non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or an exon 21 L858R mutation.

September 2018—Qiagen announced a partnership with multiple organizations to support creating a worldwide genomics campus in Manchester, U.K., for innovation, life sciences, translational science, and molecular diagnostics. Qiagen is working with Health Innovation Manchester to bring together public, academic, and clinical resources to develop the Genomic Health Innovation Campus, anchored by Qiagen’s European Centre of Excellence for Precision Medicine and hub for diagnostics development.

September 2018—Qiagen has introduced next-generation sequencing solutions for a range of hereditary diseases on its GeneReader NGS System.

August 2018—Qiagen launched the QIAseq 16S/ITS Panels and UCP Multiplex PCR Kit with a new generation of reagents to enable accurate microbial community profiling from complex microbiome samples. The UCP Multiplex PCR Kit is a standalone product as well as a component of the QIAseq 16S/ITS Panels.

July 27, 2018—Qiagen has introduced next-generation sequencing solutions for a range of hereditary diseases on its GeneReader NGS System. The customizable QIAact target enrichment panels enable the analysis of more than 13 hereditary disease groups, including inherited cancers, cystic fibrosis, inherited cardiovascular diseases, and universal carrier screening. The solutions integrate the company’s QCI analysis, which includes the Human Gene Mutation ...

July 2018—Qiagen announced the European launch of its QIAstat-Dx, a next-generation multiplex molecular diagnostic that provides a one-step, fully integrated molecular analysis of common syndromes as tested for in syndromes in infections, oncology, and other diseases.

May 2018—Qiagen and Natera will partner to develop cell-free DNA assays, including for prenatal screening, for use on the Qiagen GeneReader NGS System.

April 20, 2018—Qiagen launched two liquid biopsy panels to evaluate circulating tumor cells in prostate and lung cancers. The AdnaTest ProstateCancerPanel AR-V7 Kit and AdnaTest LungCancer Kit were introduced at the American Association for Cancer Research annual meeting, April 14–18, in Chicago. The AdnaTest ProstateCancerPanel AR-V7 Kit detects the androgen receptor splice variant 7 in CTCs of prostate tumor origin ...

April 2018—The U.S. Centers for Disease Control and Prevention issued a notification to U.S. civil surgeons stating it will require the use of FDA-approved interferon gamma release assays for tuberculosis screening. The CDC plans for the changes to medical screening guidelines to go into effect Oct. 1.

Feb. 28, 2018—The U.S. Centers for Disease Control and Prevention issued a notification to U.S. civil surgeons stating it will require the use of FDA-approved interferon gamma release assays for tuberculosis screening. The CDC plans for the change to go into effect Oct. 1. The use of the tuberculin skin test will no longer be allowed for use in immigration screening, ...

Feb. 20, 2018—Qiagen has entered into an agreement to acquire Stat-Dx, a developer of molecular diagnostics systems, for $147 million. Once the transaction is completed, which is expected later this year, Qiagen will launch the QIAstat-Dx system, a next-generation, fully integrated multiplex platform for syndromic disease testing. QIAstat-Dx enables scalable sample-to-insight processing of up to 48 molecular targets simultaneously and ...

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.

January 2018—Qiagen and Centogene announced a collaboration and comarketing agreement to provide customers more complete sample-to-insight research and clinical testing solutions in rare genetic diseases. The collaboration includes the integration of Centogene’s CentoMD rare disease variant database into Qiagen’s bioinformatics offering to enhance test interpretation.

August 2017—Qiagen has joined Cancer-ID, a public-private consortium of 36 partners from 13 countries that aims to establish standard protocols and clinical validation for blood-based biomarkers in lung and breast cancer.

April 2017—Singulex has entered into a strategic collaboration with Qiagen to develop companion diagnostics. Through the collaboration, Qiagen will have access to Singulex’s Single Molecule Counting (SMC) immunodiagnostic platform, adding immunoassay capabilities to Qiagen’s existing molecular testing services for the development of companion diagnostics.

March 2017—Qiagen announced it submitted its QuantiFeron-TB Gold Plus, the fourth generation of the modern blood test for detecting tuberculosis infection, for premarket approval by the Food and Drug Administration.

February 2017—Qiagen announced the European launch of its CE-IVD marked calreticulin mutation assay to aid in establishing the diagnosis of myeloproliferative neoplasms. The ipsogen CALR RGQ PCR kit is intended for the detection of CALR mutations in genomic DNA from subjects suspected of myeloproliferative neoplasms. It enables identification of the two major CALR mutations, type 1 and type 2, and detects additional mutations in the CALR exon 9 region.

February 2017—Qiagen launched the QIAseq cfDNA All-in-One kit, combining cell-free DNA extraction and library preparation in a dedicated solution for liquid biopsy analysis on next-generation sequencing platforms. The kit integrates with Qiagen’s PAXgene Blood ccfDNA tube as well as with the company’s bioinformatics workflow for cfDNA, creating a streamlined testing solution that aims to allow faster, more convenient, and reliable analysis of cell-free DNA from sample collection to interpreted result.

January 2017—Qiagen launched its QIAscout, a novel instrument for isolation of viable single cells from samples to enable single-cell analysis for next-generation sequencing, polymerase chain reaction, and other downstream applications.

November 2016—Qiagen launched its Paxgene Blood ccf­DNA Tube for venous whole blood collection and room temperature stabilization of in vivo circulating cell-free DNA profiles.

September 2016—Qiagen launched a liquid biopsy workflow for clinical cancer research using its GeneReader NGS System for next-generation sequencing. The Actionable Insights Tumor Panel is a sample-to-insight solution for noninvasive liquid biopsies and formalin-fixed, paraffin-embedded tissue samples.

August 2016—Qiagen has entered into a licensing and co-development agreement with Munich-based Therawis Diagnostics to develop and commercialize predictive assays in oncology. An initial project will be to develop and market PITX2 as a marker to predict the effectiveness of anthracycline treatment in triple-negative and other high-risk breast cancer patients.

July 2016—Qiagen announced that it will offer an extensive package of quality control data, generated through the application of Horizon Discovery Group’s reference standards, with its GeneReader NGS System.

May 2016—Qiagen will collaborate with 10x Genomics to develop and promote comprehensive solutions for next-generation sequencing, single-cell biology, and bioinformatics.

April 2016—Qiagen introduced more than 170 new QIAseq Targeted RNA Panels for gene expression profiling.

Qiagen and Biotype Diagnostics have entered into a partnership to establish Biotype Innovation GmbH. The new company will develop and commercialize molecular diagnostic workflows initially for personalized health care applications based on Qiagen’s proprietary ModaPlex platform, which enables customers to detect, characterize, and measure up to 100 parameters simultaneously.

Qiagen announced a collaboration with Seegene in which Seegene will develop a menu of multiplex assay panels for Qiagen’s modular QIAsymphony RGQ MDx automation platform.

July 2015—Why Sonora Quest gave itself high marks for LIS conversion; Pathologists share homegrown software for infant autopsies; CMS promotes innovation by offering data to private sector; Agilent purchases Cartagenia; Database provides information from next-gen sequencing

July 2015—Qiagen launched two Investigator STR assay kits for analysis of DNA evidence in forensic laboratories in the United States—the Investigator 24plex QS Kit for amplification of the CODIS core and European Standard Set marker sets from casework samples and the Investigator 24plex GO! Kit for direct amplification of the CODIS core and ESS marker sets from reference samples.

June 2015—Qiagen has expanded its relationship with BGI to provide Qiagen’s Ingenuity Variant Analysis in integrated bioinformatics for all customers of BGI’s sequencing services.

April 2015—Qiagen has expanded its portfolio of liquid biopsies through the acquisition of a proprietary technology from AdnaGen. The technology allows a complete solution for the detection and analysis of circulating tumor cells for clinical applications. It enriches disease-specific tumor cells using magnetic particles in an antibody mixture, then isolates and purifies messenger RNA for analysis using reverse transcription polymerase chain reaction.

April 2015—Qiagen announced the CE-IVD marking of its novel liquid biopsy-based companion diagnostic that analyzes circulating nucleic acids obtained from blood samples to assess a genomic mutation in patients with non-small cell lung cancer.

January 2015—Qiagen will offer global distribution of the RealStar Ebolavirus RT-PCR Kit 1.0. The diagnostic kit, developed and manufactured by Altona Diagnostics, is a reverse transcription polymerase chain reaction test intended for the qualitative detection of RNA from all known strains of Ebola viruses. Qiagen will distribute the kit and Altona’s already CE-IVD marked test, the RealStar Filovirus RT-PCR Kit, which is for both Ebola and Marburg viruses and does not fall under the emergency use authorization.

December 2014—To support users focused on hereditary disease, Qiagen has fully integrated Biobase HGMD Professional with Ingenuity Variant Analysis so that researchers no longer require a separate human gene mutation database license. The Ingenuity Variant Analysis is a Web-based software application that filters genetic variants in a secure, private, cloud-based environment to identify variants most likely to cause disease.

August 2014—Qiagen launched 14 GeneRead DNAseq V2 gene panels targeting a range of cancer-related genes or gene regions, including focused panels, each targeting 8–25 genes, disease-specific panels for 40–50 genes, and comprehensive panels for as many as 160 genes.

August 2014—Qiagen acquired an exclusive worldwide license to the biomarker calreticulin. Qiagen licensed the technology from CeMM Vienna, the research center for molecular medicine of the Austrian Academy of Sciences. Qiagen plans to develop a molecular diagnostic test for the CALR mutations to offer patients a clearer prognostic profile and to guide disease management.

July 2014—Qiagen’s artus C. difficile QS-RGQ MDx Kit received FDA clearance, and its QIAsymphony RGQ MDx system was granted 510(k) regulatory clearance by the FDA. In addition, the artus VanR QS-RGQ MDx Kit for detection of vancomycin-resistant bacteria, available in Europe, is expected to be submitted to the FDA this year. The artus MRSA QS-RGQ MDx Kit for methicillin-resistant Staphylococcus aureus is expected to be launched in Europe this year and submitted to the FDA in the third quarter of 2014. Test kits for diagnosis of group B streptococcus and herpes simplex virus (HSV 1/2) are in the advanced stages of development.

June 2014—QIAxpert from Qiagen is a high-speed UV/VIS spectrophotometer that enables laboratories to assess the quality and quantity of nucleic acids in up to 16 samples within just two minutes.

April 2014—Qiagen announced the launch plans of products designed to reduce the challenges of bottlenecks in next-generation sequencing: sample preparation and bioinformatics. The products add to Qiagen’s portfolio of solutions designed to run with any NGS platform.

March 2014—Qiagen expanded its strategic partnership with Exosome Diagnostics to develop a noninvasive molecular in vitro diagnostic. The novel blood-based diagnostic detects certain mutations of an undisclosed gene associated with non-small cell lung cancer and other malignancies and has the potential to be paired with several new anticancer therapeutics.

March 2014—Qiagen last year enrolled molecular diagnostics laboratories in an early access program to complete the development of a Web-based solution to deliver faster, easier-to-use, and high-confidence clinical interpretation and reporting of observed gene variants in data from NGS-based tests.

March 2014—The Mount Sinai Genetic Testing Laboratory and the Icahn Institute for Genomics and Multiscale Biology at Mount Sinai, New York City, have adopted Qiagen’s Ingenuity Variant Analysis solution for research and translational genomics applications related to characterizing and identifying rare diseases.

February 2014—Qiagen announced an agreement with Eli Lilly to develop and commercialize a molecular companion diagnostic paired with a novel Lilly oncology compound. This is the third co-development project by Qiagen and Lilly to create companion diagnostics.

Qiagen announced a partnership with Exosome Diagnostics to develop and commercialize high-performance biofluid sample preparation kits for the processing of nucleic acids from exosomes. Combining Exosome Diagnostics’ platform technology approach with select Qiagen consumables and automation platforms has the potential to allow researchers, drug developers, and medical professionals to take repeated, real-time genetic “snapshots” of disease from patients’ blood, urine, ...

Qiagen is expanding its next-generation sequencing portfolio of nine GeneRead DNAseq panels to about 20 during the course of this year. Qiagen is leveraging its molecular content and assay portfolio to create these new gene panels for targeted NGS analysis based on the GeneGlobe portfolio of more than 60,000 annotated molecular assays.

Qiagen and SIP Biotech Development have opened the Qiagen (Suzhou) Translational Medicine Center, which aims to accelerate the discovery and validation of biomarkers and to create companion diagnostics for the Chinese market. Qiagen (Suzhou) is a joint venture of Qiagen and BioBay, a life sciences cluster in Suzhou Industrial Park, near Shanghai.

Qiagen announced two agreements that add biomarkers involving glioblastoma, lymphoma, and other cancers to the company’s portfolio of potential companion diagnostics. In the glioblastoma project, Qiagen has entered into an exclusive worldwide licensing option with Columbia University in New York on FGFR-TACC fusion genes. Qiagen intends to develop this biomarker into a test for routine use in diagnostic workups, which may allow doctors to identify glioblastoma patients who could benefit from targeted treatments.

Qiagen offers a sample-to-result next-gen sequencing workflow designed to enable the routine use of NGS technology in areas such as clinical research and diagnostics. Qiagen’s NGS workflow is an ecosystem of products and services that offer automated processes from primary sample to digital result.

Qiagen announced three separate agreements that add biomarkers to its diagnostic pipeline for personalized health care applications to guide treatments with various medicines based on a patient’s genomic information.

Qiagen has submitted to the FDA its Therascreen EGFR RGQ PCR kit as a proposed companion diagnostic test to guide treatment with afatinib, an investigational oncology compound developed by Boehringer Ingelheim. The FDA has accepted afatinib for filing and granted it priority review as a proposed treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with an EGFR mutation detected by an FDA-approved test.