Category: Disease States

Disease States

FDA Clears Multiplex PCR Panel for 13 Respiratory Pathogens

The multiplex PCR assay detects 13 viral and bacterial respiratory pathogens from a swab.

CND Life Sciences Opens Scottsdale Innovation Lab to Expand Neurodiagnostic Assay Development
Blood Test Differentiates Bacterial and Viral Infections in Febrile Infants
Decipher Prostate Test Predicts Benefit from Hormone Therapy in Phase III Trial
Revvity Launches IVDR-Certified Triplex Autoantibody Assay for Early Type 1 Diabetes Screening
Coffee Mug Powers Portable Test for Seven Mosquito-Borne Viruses
Ambulance Troponin Testing Helps One-Third of Chest Pain Patients Avoid the ED
DNA Test Diagnoses Inherited Muscle Diseases Missed by Standard Testing
FDA Advisory Panel Backs Approval of GRAIL’s Galleri Multi-Cancer Early Detection Test
Lucid Diagnostics Secures Favorable Medicare, CPT, and ICD-10 Recommendations for Esophageal Cancer Tests

Disease States

Tampa General Adopts Host-Response Test After Study Shows 33% Drop in Cefepime Use

Tampa General Hospital is the first in the Southeast to implement the MeMed BV host-response test in its emergency workflow, reporting a 33% reduction in cefepime use and 13% fewer hospitalizations, according to hospital-led research.

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

bioAffinity Secures Hong Kong Patent for Lung Cancer Detection Technology

bioAffinity Technologies has received a Hong Kong patent for its CyPath Lung diagnostic platform, expanding intellectual property protection for its noninvasive lung cancer detection technology in the Asian market.

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.