Category: Disease States

Disease States

Researchers Develop Blood Test That May Detect Testicular Cancer Missed by Standard Markers

Mayo Clinic researchers have developed a blood test that detected 93% of germ cell tumors—including cases missed by standard markers.

Disease States

Illumina Partners Advance Cancer Research with Multiomics Technologies

Studies demonstrate spatial transcriptomics, 5-base sequencing, and proteomics applications in oncology diagnostics and therapeutic development.

Disease States

Bringing Clarity to Autoimmune and Allergy Diagnostics

As autoimmune and allergy test volumes rise, labs are prioritizing workflow standardization and structured testing pathways to ensure reliable results, according to Santhosh Nair, president of immunodiagnostics at Thermo Fisher Scientific.

Cancer

Amplified Sciences Receives CAP Accreditation for Clinical Diagnostic Laboratory

Amplified Sciences has received CAP accreditation for its clinical laboratory, enabling broader commercial deployment of its PanCystPro assay for pancreatic cancer risk assessment, the company announced.

Infectious Diseases

Study Finds Undiagnosed Tuberculosis DNA in US Patients Using Ultrasensitive Test

A Boston University study found TB DNA in 12% to 16% of respiratory samples from hospitalized patients in a low-incidence area using an ultrasensitive assay, suggesting underdiagnosis of tuberculosis in the US.

Womens Health

Labcorp Launches Companion Diagnostic for Ovarian Cancer Treatment

Labcorp has launched nationwide testing with Agilent’s FDA-approved PD-L1 IHC 22C3 pharmDx, enabling identification of patients with platinum-resistant ovarian cancer eligible for pembrolizumab immunotherapy.

Allergy & Autoimmune

Roche Receives CE Mark for Multiple Sclerosis Blood Test

The Elecsys NfL test measures a protein associated with nerve cell injury to monitor disease activity in patients with relapsing remitting multiple sclerosis.

Cardiovascular, Cerebrovascular

Updated Guideline Issued on Lipid and Cholesterol Management, Expanding Role of Key Biomarker Tests

The ACC, AHA, and nine other associations have issued an updated dyslipidemia guideline, recommending earlier intervention and expanded use of lipoprotein(a) and apolipoprotein B testing to improve cardiovascular risk assessment.

Dementias & Alzheimer’s

Clinical Trial to Evaluate Finger-Prick Blood Test for Alzheimer’s Diagnosis

The study will analyze three key proteins to determine if blood-based biomarkers can provide an earlier and more accessible diagnostic method.

Diabetes & Metabolic Diseases

New Blood Test Score Identifies Hidden Alcohol-Related Liver Disease

Researchers at UC San Diego have developed the MAPI score, a blood test using five standard lab values to distinguish alcohol-related liver injury from metabolic causes, according to a study in Gastroenterology.

Kidney Disease

Insight Molecular Diagnostics Nears FDA Submission for Kidney Transplant Rejection Test Kit

Insight Molecular Diagnostics has completed clinical validation and received ISO 13485 certification for its GraftAssureDx kidney transplant rejection test kit, moving toward FDA submission, according to the company.

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

Sepsis Diagnostic Test Shapes ED Physician Decision-Making, Study Finds

A multicenter, vignette-based study found that adding a rapid sepsis test result to standard clinical data changed or reinforced diagnostic decisions in 86% of cases.