Category: Disease States

Disease States

Siemens Healthineers Launches FDA-Cleared D-Dimer Blood Test

Siemens Healthineers has launched the FDA-cleared Innovance D-Dimer 2.0 assay, designed for rapid exclusion of DVT and PE in outpatients and optimized for STAT laboratory testing.

Disease States

FDA Advisory Panel Backs Approval of GRAIL’s Galleri Multi-Cancer Early Detection Test

An FDA advisory panel voted 7-2 that the benefits of GRAIL’s Galleri multi-cancer early detection blood test outweigh its risks for adults 50 and older, supporting its premarket approval application.

Disease States

FDA Clears Next-Generation Metrix COVID Test Delivering 3-Fold Higher Sensitivity

The FDA has cleared Aptitude’s next-generation Metrix COVID Test, which the company says offers 3-fold higher sensitivity and 30% faster results compared to its EUA version.

Cancer

Electronic Genome Mapping Matches Cytogenetic Findings in Leukemia Proof-of-Principle Study

A study led by Augusta University found 100% concordance between Nabsys OhmX electronic genome mapping and standard cytogenetic methods in detecting pathogenic variants in AML and CML bone marrow samples.

Infectious Diseases

Multicenter Lab Network Evaluates Four Bundibugyo Virus PCR Assays in Two Weeks

A nine-lab network evaluated four Bundibugyo virus PCR assays from two manufacturers in two weeks during the 2026 outbreak, establishing new reference standards, according to a study in The Lancet Infectious Diseases.

Womens Health

AMH Fertility Testing Rose 13-Fold Despite Inability to Predict Natural Conception, Study Finds

General practitioner requests for AMH fertility tests rose more than 13-fold from 2011 to 2021, despite research showing these tests cannot predict natural conception, according to a Flinders University study of 1.4 million health records.

Allergy & Autoimmune

Genetic Tests Used Before Lamotrigine May Miss Severe Reaction Risk

A Vanderbilt study finds that standard genetic tests for lamotrigine reaction risk omit HLA-A*32:01, a marker linked to severe DRESS, raising concerns about current pharmacogenomic panel effectiveness.

Cardiovascular, Cerebrovascular

Rapid Cardiac Troponin Testing Does Not Reduce Emergency Department Length of Stay

A large trial finds that the rapid 0/1-hour cardiac troponin testing pathway is as safe as standard methods but does not reduce emergency department length of stay or increase direct discharge rates.

Dementias & Alzheimer’s

Combining p-tau217 Blood Tests with APOE4 Genotyping Forecasts Alzheimer’s Symptom Onset, Study Finds

A Columbia University study finds that combining plasma p-tau217 blood tests with APOE4 genotyping can predict Alzheimer’s symptom onset within three to four years in high-risk, asymptomatic individuals.

Diabetes & Metabolic Diseases

Genetic Risk Score Identifies Hidden Type 1 Diabetes in MODY Referrals

A University of Exeter study finds that adding a genetic risk score to MODY testing can identify hidden type 1 diabetes in 16% of patients with negative genetic results, supporting updated NHS diagnostic protocols.

Kidney Disease

Urine Biomarker Test Improves Prediction of Donor Kidney Outcomes

A Johns Hopkins study reports that adding three urine biomarkers to standard assessments raises the accuracy of predicting deceased donor kidney transplant success from 80% to 86%.

Respiratory Disease

Yourgene Health Cystic Fibrosis Assay Receives IVDR Accreditation

The Cystic Fibrosis Base assay has received IVDR accreditation, ensuring high standards for detecting cystic fibrosis mutations.

Sepsis

Clinical Study Validates H3.1 Nucleosomes as Sepsis Biomarker

A study validates Nu.Q NETs H3.1 nucleosomes as independent predictors of 28-day mortality and renal replacement therapy need in sepsis and septic shock, according to VolitionRx.