Qiagen Stock Price, News & Analysis

QIAGEN has announced the certification of its QuantiFERON-TB Gold Plus test under the new EU In Vitro Diagnostic Medical Devices Regulation (IVDR), classified as Class C. This certification marks a key milestone in QIAGEN's compliance with EU regulations aimed at enhancing diagnostic performance and safety. The QuantiFERON-TB Gold Plus test is recognized globally, including by WHO, for its effectiveness in detecting tuberculosis. As part of its commitment, QIAGEN is transitioning over 180 products to meet the IVDR standards, ensuring continued supply and compliance moving forward.

QIAGEN N.V. (NYSE: QGEN) reported Q4 2022 net sales of $498 million, a 14% decline year-over-year, with sales at constant exchange rates (CER) at $531 million. The adjusted diluted EPS was $0.53, exceeding expectations. Non-COVID product sales grew 15% to $432 million. For full-year 2022, net sales were $2.14 billion with a 5% decline but profits were strong, showing adjusted diluted EPS of $2.38. Looking ahead, QIAGEN aims for 2023 net sales of at least $2.05 billion with continued growth in non-COVID products.

QIAGEN has launched the EZ2 Connect MDx platform for diagnostic laboratories, enhancing sample processing capabilities 18 months after its research introduction. This automated device purifies DNA and RNA from 24 samples in approximately 30 minutes and is CE-IVD compliant, enabling its use across the EU, U.S., Canada, and more. With over 5,000 EZ platforms deployed globally, EZ2 Connect MDx integrates with the QIAsphere digital system for remote management, meeting the fast-paced demands of clinical diagnostics. It addresses various sample types, employing magnetic-bead technology and ensuring high process safety.

QIAGEN N.V. (NYSE: QGEN) has announced its upcoming fourth quarter and full-year 2022 results, set to be released on February 7 at 22:05 Frankfurt time. Following this, a conference call is scheduled for February 8 at 15:00 Frankfurt time, where key business updates and financial performance will be discussed. The company provides solutions in molecular diagnostics, applied testing, pharma, and academia, serving over 500,000 customers globally. As of September 30, 2022, QIAGEN employed over 6,200 people across 35 locations worldwide.

QIAGEN has announced the completion of its acquisition of Verogen for $150 million in cash, enhancing its position in the next-generation sequencing (NGS) market for forensic applications. This acquisition follows a partnership that began in June 2021 and is expected to generate $20 million in sales from Verogen’s offerings in 2023. However, it will be dilutive to QIAGEN’s adjusted EPS by about $0.03 per share for 2023. The integration of Verogen’s technology is anticipated to broaden QIAGEN’s capabilities in human identification and forensic investigations.

QIAGEN has entered an exclusive partnership with Helix to enhance companion diagnostics for hereditary diseases. The collaboration will utilize Helix's laboratory platform and QIAGEN's regulatory expertise to accelerate patient recruitment and real-world evidence generation. This partnership aims to provide innovative diagnostic solutions for neuro-degenerative, cardiovascular, and autoimmune diseases, benefiting hundreds of millions globally. QIAGEN will exclusively market Helix's companion diagnostic services in the U.S., leveraging their extensive network and experience in precision medicine.

Helix and QIAGEN have announced a global strategic partnership to co-develop companion diagnostics for hereditary diseases. This collaboration will utilize the Helix Laboratory Platform alongside QIAGEN's diagnostic technologies. The partnership aims to tackle significant health issues, such as neuro-degenerative and cardiovascular diseases. Helix's platform is the first FDA-approved Class II diagnostic system, enhancing patient recruitment for clinical trials. The two companies plan to reveal further details at the upcoming JPMorgan Health Care Conference in San Francisco.

QIAGEN has received FDA approval for its therascreen KRAS RGQ PCR kit as a companion diagnostic for KRAZATI (adagrasib), targeting non-small cell lung cancer (NSCLC) patients with KRAS G12C mutations. This marks the 4th approval of the kit, expanding treatment options for an underserved population with high unmet needs. The kit is designed for fast, cost-effective testing, allowing for timely and informed treatment decisions. QIAGEN's advancements reflect strong collaboration with Mirati Therapeutics and underscore their leadership in RAS companion diagnostics.

QIAGEN N.V. (NYSE: QGEN) reported Q3 2022 net sales of $500 million, down 7% year-over-year, but above expectations of $510 million at constant exchange rates (CER). Adjusted diluted EPS was $0.53, exceeding a forecast of $0.48 CER. Notably, the non-COVID product portfolio saw 18% CER growth to $417 million. The company raised its full-year sales outlook to $2.25 billion CER and adjusted diluted EPS to $2.40 CER, reflecting strong cash flow and robust demand for its solutions.