Diagnostics

Feb. 14, 2025

Offers expectant parents fully comprehensive prenatal screening test for genetic conditions, including microdeletions.

Diagnostics

LVIS Corporation launches NeuroMatch Pro

LABline

Feb. 13, 2025

Diagnostics

Ibex Medical Analytics receives first FDA 510(k) clearance

LABline

Feb. 11, 2025

Diagnostics

Thermo Fisher Scientific announces 510(k) clearance of molecular clinical test for SARS-CoV-2, Flu A, Flu B, and RSV

LABline

Feb. 10, 2025

Diagnostics

PSMA-PET may uncover more than traditional prostate cancer imaging

Erin Brady

Feb. 5, 2025

Diagnostics

Certain racial and ethnic groups are travelling farther for lung cancer screening

Erin Brady

Feb. 4, 2025

Diagnostics

Roche receives FDA approval for the first companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for ENHERTU

LABline

Feb. 3, 2025

The PATHWAY HER2 (4B5) test, the first and only FDA-approved companion diagnostic for assessing HER2-low status since 2022, is now also approved to aid in the assessment of HER2...

Diagnostics

New study shows stride in Alzheimer's diagnosis

Erin Brady

Jan. 30, 2025

Two assays were studied.

Assays

Roche receives FDA 510(k) clearance for the first blood test in the U.S. measuring Lp(a) in molar units

LABline

Jan. 30, 2025

The Roche Diagnostics Tina-quant Lipoprotein (a) Gen.2 Molarity assay is an in-vitro test measuring lipoprotein (a) in a person’s bloodstream (serum and plasma), and will be broadly...

Diagnostics

Beckman Coulter receives FDA Breakthrough Device Designation for Alzheimer’s disease blood test

LABline

Jan. 29, 2025

This blood test is designed to aid healthcare providers identify patients with amyloid pathology associated with Alzheimer's disease.

Biomarkers

Beckman Coulter Diagnostics joins the Bio-Hermes-002 study as new partner

LABline

Jan. 27, 2025

The Bio-Hermes-002 study aims to improve participation from people who are traditionally underrepresented in Alzheimer’s clinical research.

Assays

Roche receives FDA clearance with CLIA waiver for cobas liat molecular tests to aid in diagnosing sexually transmitted infections at the point of care

LABline

Jan. 24, 2025

FDA CLIA-waived tests broaden access to accurate, easy-to-use diagnostics for all patients in decentralized settings like urgent care centers, retail clinics, and community health...

Pathology

Mayo Clinic’s effort to expedite medical breakthroughs

LABline

Jan. 23, 2025

New Mayo Clinic Digital Pathology launched.

2501ogt22jan_ogts_new_sureseq_myeloid_mrd_panel

Diagnostics

OGT launches new SureSeq Myeloid MRD Panel

LABline

Jan. 22, 2025

Ultra-low variant detection (including very large FLT3-ITDs) enables a stronger characterization of a sample’s current AML status.

Diagnostics

Roche receives FDA clearance for new, highly sensitive test to aid clinicians in diagnosing B-cell lymphoma

LABline

Jan. 14, 2025

The test helps differentiate a B-cell cancer from a normal, reactive immune response.

Diagnostics

Revvity announces FDA Clearance for first automated free testosterone test

LABline

Jan. 13, 2025

This innovative test is the first of its kind to receive FDA clearance for direct quantitative measurement of free testosterone levels.

Diagnostics

Diagnostics

First G6PD diagnostic test prequalified by WHO

LABline

Jan. 13, 2025

Pathology

Roche awarded FDA clearance on its high-volume slide scanner

LABline

Jan. 10, 2025

Diagnostics

QIAGEN secures U.S. clearance for first QIAstat-Dx mini gastrointestinal panel to support year-round outpatient care

LABline

Jan. 10, 2025

Diagnostics

ClearNote Health’s Avantect Multi-Cancer Detection Test selected for National Cancer Institute’s Vanguard Study

LABline

Jan. 8, 2025

Pathology

Deciphex secures $32.3M Series C to address global pathology shortage

LABline

Jan. 8, 2025

Diagnostics

VERICHEM LABORATORIES offers bio-synthetic clinical reference materials for urine chemistries

LABline

Jan. 3, 2025

Diagnostics

Brain structure and adolescent substance use

Erin Brady

Jan. 2, 2025

Yourgene Health launches IONA Care+ non-invasive prenatal testing service

LVIS Corporation launches NeuroMatch Pro

Ibex Medical Analytics receives first FDA 510(k) clearance

Thermo Fisher Scientific announces 510(k) clearance of molecular clinical test for SARS-CoV-2, Flu A, Flu B, and RSV

PSMA-PET may uncover more than traditional prostate cancer imaging

Certain racial and ethnic groups are travelling farther for lung cancer screening

Roche receives FDA approval for the first companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for ENHERTU

New study shows stride in Alzheimer's diagnosis

Roche receives FDA 510(k) clearance for the first blood test in the U.S. measuring Lp(a) in molar units

Beckman Coulter receives FDA Breakthrough Device Designation for Alzheimer’s disease blood test

Beckman Coulter Diagnostics joins the Bio-Hermes-002 study as new partner

Roche receives FDA clearance with CLIA waiver for cobas liat molecular tests to aid in diagnosing sexually transmitted infections at the point of care

Mayo Clinic’s effort to expedite medical breakthroughs

OGT launches new SureSeq Myeloid MRD Panel

Roche receives FDA clearance for new, highly sensitive test to aid clinicians in diagnosing B-cell lymphoma

Revvity announces FDA Clearance for first automated free testosterone test

Diagnostics

First G6PD diagnostic test prequalified by WHO

Roche awarded FDA clearance on its high-volume slide scanner

QIAGEN secures U.S. clearance for first QIAstat-Dx mini gastrointestinal panel to support year-round outpatient care

ClearNote Health’s Avantect Multi-Cancer Detection Test selected for National Cancer Institute’s Vanguard Study

Deciphex secures $32.3M Series C to address global pathology shortage

VERICHEM LABORATORIES offers bio-synthetic clinical reference materials for urine chemistries

Brain structure and adolescent substance use