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Qiagen announced the certification of QuantiFERON-TB Gold Plus - a tuberculosis blood test - under the European Union's 2017/746 In Vitro Diagnostic Medical Devices Regulation which is replacing the 98/79/EC In Vitro Diagnostic Directive. QFT-Plus is QIAGEN's trusted test, endorsed by the WHO, that aids in indirect detection of the bacteria that causes tuberculosis. The IVDR certification of QFT-Plus follows the QIAGEN ipsogen JAK2 RGQ PCR Kit as well as the NeuMoDx Systems and reagents, which gained IVDR CE-marking in late 2022. The updated set of rules, which became effective May 26, 2022, is now imposing higher and broader requirements on IVD manufacturers to receive CE-marking for their products. It also includes stronger oversight by independent EU-designated organizations, referred to as Notified Bodies. QuantiFERON-TB Gold Plus is classified as a Class C device under IVDR. With its more stringent mandates, the European regulatory framework comes closer to the FDA IVD regulations in the US and aims to ensure higher quality of health services for patients.

Singular Genomics Systems (OMIC) released new data from 11 industry-leading genomics partners that validate the performance and versatility of the G4 Sequencing Platform. The datasets are being released during the Advances in Genome Biology and Technology, AGBT, 23rd General Meeting taking place February 6-9, 2023, in Hollywood, Florida. The datasets, available as application notes and posters at the AGBT meeting and on the Singular Genomics website, are with the following industry-leading genomics partners: 10x Genomics (TXG), Integrated DNA Technologies, Bio-Rad Laboratories (BIO), QIAGEN (QGEN), Quantabio, Parse Biosciences, Takara Bio, Paragon Genomics, Watchmaker Genomics, Claret Bioscience, and Tecan. "The data with our partners underscores the versatility of the G4 to address our customers' various sequencing needs, producing highly accurate results with unmatched flexibility and speed," said Drew Spaventa, Chairman and Chief Executive Officer of Singular Genomics.

Genetic Technologies (GENE) announced that the Company is forming a strategic alliance with QIAGEN (QGEN). The alliance will establish and develop a 'Centre of Excellence' facility in Australia initially servicing Australia and New Zealand with potential for expansion, showcasing the Life Science and Diagnostics expertise of both organizations throughout the region. The partnership will further enhance GTG's reputation as a regional leader in precision medicine in predicative and consumer genomics, utilizing QIAGEN technologies.The relationship is expected to open a wide range of new commercial opportunities for GTG with enhanced automation capability and increased capacity supporting long-term revenue growth. Additionally, this initiative will unlock the Australian reimbursable market for all testing categories, including the geneType hereditary cancer test. This will make the geneType Breast, Ovarian and Colorectal cancer tests the most comprehensive offering in the market later in 2023. Gaining reimbursement coverage for geneType cancer assessment tests is expected to accelerate the adoption of these tests by General Practice clinics where patients are able to undertake the test with minimal out-of-pocket expenses. QIAGEN will support the enhancement of GTG capabilities through software, hardware, consumable and technical solutions, including: the reagents and QIAGEN's proprietary QCII software to complete Next Generation Sequencing validation in house. The rollout will include QIAGEN's QIAseq targeted DNA Pro Sample to Insight solutions for NGS Oncology and customized inhouse data analysis tools to provide sample to result service for GTG customers; collection devices, hardware, reagents and panels to equip GTG with the required laboratory scale to perform tests in-house; capability to multiplex on different scalable platforms; and provide technical support and the establishment of protocols for GTG to perform the tests for NATA accreditation for QIAGEN related Technologies.