Category: Disease States

Disease States

FDA Clears QIAGEN Bloodstream Infection Panel

QIAGEN has received FDA clearance for its QIAstat-Dx BCID GPF Plus AMR Panel, enabling detection of 20 pathogens and 10 antimicrobial resistance markers from positive blood cultures in about one hour.

Disease States

Caris Life Sciences Launches PTEN IHC Testing for Prostate Cancer

Caris Life Sciences has launched in-house PTEN IHC testing to identify prostate cancer patients eligible for FDA-approved, biomarker-guided therapy, supporting precision treatment for PTEN-deficient mAPMN/S prostate cancer.

Disease States

Building a Better Picture of Cancer

Clinical labs are adopting broader cancer diagnostics—including whole-genome sequencing and multi-omic testing—to deliver more comprehensive molecular insights and improve disease monitoring.

Cancer

Labcorp Launches FDA-Approved IHC Companion Diagnostic for Prostate Cancer

Labcorp is offering nationwide access to Roche’s FDA-approved VENTANA PTEN (SP218) RxDx Assay, the first IHC companion diagnostic to identify PTEN protein loss in prostate cancer and guide eligibility for combination therapy with capivasertib.

Infectious Diseases

Bacterial Vaginosis Triples STI Risk in Women, Quest Diagnostics Study Finds

A Quest Diagnostics study of 1.5 million women found those with bacterial vaginosis are over three times more likely to have a non-viral STI, highlighting the need for comprehensive diagnostic testing.

Womens Health

Real-World Study Supports Multi-Omic Blood Test for Endometriosis

HerAnova Lifesciences reported real-world data on its HerResolve multi-omic blood test for endometriosis at the 2026 Midwest Reproductive Annual Symposium, showing consistent performance across 197 cases in diverse clinical settings.

Allergy & Autoimmune

Protein Biomarker May Predict Sjögren’s Disease Years Before Symptoms

A new ultrasensitive blood test may detect Sjögren’s disease more than 10 years before symptoms appear by identifying chronically elevated interferon alpha levels in patient blood samples.

Cardiovascular, Cerebrovascular

Labcorp Launches Consumer Genetic Health Panel for Hereditary Risk Assessment

Labcorp has announced the upcoming launch of the Marker by Labcorp Genetic Health Panel, which will analyze 163 genes linked to over 100 medically actionable conditions, with results supported by licensed genetic counselors.

Dementias & Alzheimer’s

UK Researchers Evaluate Alzheimer’s Blood Test in Primary Care

Imperial College London has begun integrating C2N’s PrecivityAD2 blood test into primary care pathways for Alzheimer’s diagnosis, as part of the BEAD-PC study and the Davos Alzheimer’s Collaborative initiative.

Diabetes & Metabolic Diseases

Immunoassays May Underestimate HbA1c in Patients with Sickle Cell Trait

Research presented at ADLM 2026 indicates immunoassays may significantly underestimate HbA1c in patients with sickle cell trait, suggesting HPLC offers more reliable diabetes screening for populations with hemoglobin variants.

Kidney Disease

New Study Links Biomarker Elevations to Kidney Transplant Failure Risk

Elevated donor-derived cell-free DNA levels are linked to higher kidney transplant failure risk, suggesting earlier detection of allograft injury before loss of kidney function.

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

FDA Clears New Automated Blood Culture System for Faster Sepsis Detection

The BD BACTEC FXI Culture System reduces detection time for bloodstream infections by approximately three hours compared to previous models.