By Diagnostics World Staff
July 28, 2026 | Myriad Genetics announces the full commercial launch of FirstGene Multiple Prenatal Screen; Amprion reaches an agreement with Decathlon Capital Partners for a significant growth-funding investment; and more.
Myriad Genetics announced the full commercial launch of FirstGene Multiple Prenatal Screen, the only lab test that runs four prenatal genetic screens simultaneously from a single blood draw as early as eight weeks gestation. The FirstGene screen delivers fetal chromosome screening, fetal single-gene screening, patient carrier screening, and fetal RhD screening in one integrated report. The screen has greater than 98% analytical sensitivity and greater than 99% analytical specificity. Press release.
Riccio College of Engineering at the University of Massachusetts Amherst received a two-year, $1.3 million award from the National Institutes of Health to advance proof-of-concept work toward commercialization for at-home HIV tests sensitive enough for early diagnosis comparable to—or exceeding—lab standards. This new grant for the phase 2 trial supports the development of their prototype to make it ready for commercialization. This includes refining the prototype design and clinically validating it for self-testing use with 300 patients at Prisma Health in South Carolina. Press release.
QIAGEN launched the CE-IVDR-certified QIAstat-Dx BCID GN Plus AMR Panel. The panel detects 13 gram-negative bacterial pathogen targets and 18 antimicrobial resistance (AMR) markers from positive blood cultures in about one hour. It complements the recently launched QIAstat-Dx BCID GPF Plus AMR Panel in Europe, extending QIAGEN's bloodstream infection testing coverage across gram-positive bacteria, gram-negative bacteria, fungi and key AMR markers. Together, the two panels detect 33 pathogen targets and 28 AMR markers, enabling rapid identification of the most clinically relevant bloodstream pathogens and resistance mechanisms to support earlier pathogen identification and clinical decision-making. Press release.
NeoGenomics announced the launch of PTEN IHC CDx, the first immunohistochemistry (IHC) companion diagnostic test approved by the FDA for patients with prostate adenocarcinoma. The test identifies PTEN protein loss, also known as PTEN deficiency, in patients who may be eligible for AstraZeneca’s recently approved targeted therapy TRUQAP (capivasertib). The test is available as a standalone order or as part of NEO PanTracer Pro for prostate cancer, a comprehensive molecular workup that combines CGP and cancer-type-directed IHC testing in a single order built to evolve with new treatment options. Press release.
C2N Diagnostics announced that beginning October 1, 2026, eligible Anthem Blue Cross and Blue Shield members will be the first in the United States to receive insurance coverage under a medical policy for the PrecivityAD2 blood test. This policy expands patient access to an innovative blood-based diagnostic test that helps health care professionals evaluate adults experiencing cognitive decline or other signs and symptoms associated with Alzheimer's disease. By providing coverage for eligible patients, the policy helps reduce financial barriers to testing and expands access to innovative diagnostic technologies when deemed medically necessary by a health care professional. Press release.
Quest Diagnostics integrated its Haystack MRD ctDNA test and Comprehensive Genomic Profiling services for solid tumor cancers within OncoEMR, an electronic health record from Flatiron Health, via a pilot program with American Oncology Network and other community oncology providers. Once completed, the integration will enable 4,700 clinicians across the Flatiron network of 1,600 community-based cancer care locations in the United States to quickly access the Quest services. Press release.
Seegene’s U.S. subsidiary, Seegene USA, received an Emergency Use Authorization EUA from the FDA for the Allplex HSV-1&2/VZV/MPXV Assay, a multiplex real-time PCR assay designed to simultaneously detect multiple viral pathogens associated with clinically overlapping lesion presentations. Seegene’s assay is designed to enable the concurrent detection of herpes simplex virus type 1 and type 2 (HSV-1, HSV-2), varicella-zoster virus (VZV), and monkeypox virus (MPXV) in a single test. The Allplex HSV-1&2/VZV/MPXV Assay is the first multiplex PCR test designed to simultaneously and differentially detect viral pathogens of ulcerative skin lesions in the U.S. market. Press release.
Seegene also announced the launch of the Global Million Clinical Study (GMCS), aiming to evaluate the clinical utility and potential impact of comprehensive syndromic PCR testing approaches using real-world data. This project is scheduled to begin in South Korea and at healthcare institutions across the world to accumulate large-scale global testing data and assess the clinical value of disease-specific testing approaches for major infectious diseases. The goal is to build the scientific basis for new global testing standards and support a more comprehensive and accurate diagnostic environment, in which everyone, regardless of country or region, can access the best testing currently available. Press release.