QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the U.S. Food and Drug Administration (FDA) has cleared the QIAstat-Dx Meningitis/Encephalitis Panel for clinical use.

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the U.S. Food and Drug Administration (FDA) has cleared the QIAstat-Dx Respiratory Panel Mini test for clinical use. It is the third test to receive FDA clearance for use with QIAstat-Dx systems in 2024.

Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, today announced results for the third quarter ended September 30, 2024 and updated full-year guidance.

Thermo Fisher Scientific, the world leader in serving science, has received approval from the U.S. Food and Drug Administration (FDA) for its Ion Torrent™ Oncomine™ Dx Target Test as a companion diagnostic (CDx) to identify patients eligible for treatment with Servier Pharmaceuticals, LLC’s VORANIGO® (vorasidenib) tablets. VORANIGO is an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, sub-total resection or gross total resection. As the first targeted therapy for Grade 2 IDH-mutant glioma, VORANIGO provides a new care path for patients with extremely limited treatment options.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the VENTANAⓇ CLDN18 (43-14A) RxDx Assay is the first U.S. Food and Drug Administration (FDA) approved immunohistochemistry (IHC) companion diagnostic for determining CLDN18 protein expression in tumours of patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma. These patients now may be eligible for treatment with Astellas' targeted therapy VYLOYTM (zolbetuximab).

Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®Liquid CDx to be used as a companion diagnostic for Itovebi™ (inavolisib) in combination with palbociclib (Ibrance®) and fulvestrant, a therapy developed by Genentech, a member of the Roche group, which has been contemporaneously approved for the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.

Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today it has expanded its portfolio of sexually transmitted infection (STI) testing options to include the First to Know® Syphilis Test, the first over-the-counter blood test granted market authorization by the U.S. Food & Drug Administration (FDA) that can be performed by both physicians and patients.

Healgen Scientific LLC, a leading innovator in diagnostic solutions, announced the U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorization for Healgen Rapid Check® COVID-19/Flu A&B Antigen Test for over-the-counter (OTC) use. Click here for FDA Release. The FDA's De Novo pathway is designed for medical devices that do not have legally marketed comparison device and is a unique opportunity for development of a new device classification that can improve patient care and outcomes.

Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, today announced the U.S. Food and Drug Administration (FDA) approved the Cologuard Plus™ test, the company’s next generation multitarget stool DNA test. The Cologuard Plus test is now approved for adults ages 45 and older who are average risk for colorectal cancer (CRC).

Diasorin (FTSE MIB: DIA) today announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the LIAISON PLEX® Gram-Negative Blood Culture Assay, the second of the three molecular multiplexing panels for Blood Culture identification on the LIAISON PLEX®.