We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

LabMedica

Download Mobile App
Recent News Expo Clinical Chem. Molecular Diagnostics Hematology Immunology Microbiology Pathology Technology Industry Focus

Diagnostic Tests For Lung And Colon Cancer Launched In Europe

By LabMedica International staff writers
Posted on 12 May 2016
Print article
Image: The MassARRAY Dx analyzer system (Photo courtesy of Agena Bioscience).
Image: The MassARRAY Dx analyzer system (Photo courtesy of Agena Bioscience).
A unique combination of reliability, sensitivity, ease of use, and cost-effectiveness for targeted genetic testing for cancer has now become available to molecular pathologists.

The multiplexed assays allow the user to concurrently analyze the relevant oncogenes and thereby reduce cost and turnaround time compared to existing methods. The two test panels support personalized treatment and improved patient care through rapid analysis of clinically actionable mutations implicated in lung and colon cancer.

Agena Bioscience (San Diego, CA; USA) has launched its Conformité European In Vitro Diagnostic Medical Devices (CE-IVD) marked MassARRAY Dx products in Europe. Two targeted diagnostic panels will be sold, the MassARRAY Dx Lung Panel and the MassARRAY Dx Colon Panel, in addition to the company’s MassARRAY Dx instrumentation.

The MassARRAY Dx Colon Panel simultaneously analyzes over 200 mutations in the four major oncogenes involved in the pathogenesis of colorectal cancer (KRAS, BRAF, NRAS, and PIK3CA), using less than 40 ng of DNA extracted from fresh, frozen, or paraffin-embedded tissue. The MassARRAY Dx Lung Panel simultaneously analyzes over 300 mutations in 10 genes implicated in the pathogenesis of lung cancer (EGFR, KRAS, BRAF, PIK3CA, NRAS, ALK, ERBB2, DDR2, MAP2K1, and RET), using less than 40ng of DNA extracted from fresh, frozen, or paraffin-embedded tissue.

The CE-IVD marked MassARRAY Dx products, consisting of the MassARRAY Dx Colon Panel, MassARRAY Dx Lung Panel, and MassARRAY Dx instrumentation (MassARRAY Dx Analyzer 4, MassARRAY Dx Nanodispenser RS 1000), are sold exclusively in Europe for diagnostic use, and are not available for sale in the USA. Peter M. Dansky, MS, MBA, Chief Executive Officer of Agena Bioscience, said, “Our entry into the European clinical diagnostics market is a pillar of Agena’s global strategy to grow its clinical business with targeted, clinically actionable tests. The MassARRAY Dx Lung and Colon Panels will provide rapid and reliable diagnostic results to help physicians select the most effective treatments for their oncology patients.”

Related Links:
Agena Bioscience

Platinum Member
COVID-19 Rapid Test
OSOM COVID-19 Antigen Rapid Test
Magnetic Bead Separation Modules
MAG and HEATMAG
Complement 3 (C3) Test
GPP-100 C3 Kit
New
Gold Member
Liquid Ready-To-Use Lp(a) Reagent
Lipoprotein (a) Reagent

Print article

Channels

Clinical Chemistry

view channel
Image: The new ADLM guidance will help healthcare professionals navigate respiratory virus testing in a post-COVID world (Photo courtesy of 123RF)

New ADLM Guidance Provides Expert Recommendations on Clinical Testing For Respiratory Viral Infections

Respiratory tract infections, predominantly caused by viral pathogens, are a common reason for healthcare visits. Accurate and swift diagnosis of these infections is essential for optimal patient management.... Read more

Molecular Diagnostics

view channel
Image: Molecular PCR-grade detection of Lyme bacteria right at the tick bite (Photo courtesy of En Carta Diagnostics)

Groundbreaking Molecular Diagnostic Kit to Provide Lyme Disease Detection in Minutes

Lyme disease, transmitted through tick bites, is a bacteria-caused illness that impacts 1.2 million individuals annually. The standard methods for diagnosing this disease include clinical examinations,... Read more

Hematology

view channel
Image: The CAPILLARYS 3 DBS devices have received U.S. FDA 510(k) clearance (Photo courtesy of Sebia)

Next Generation Instrument Screens for Hemoglobin Disorders in Newborns

Hemoglobinopathies, the most widespread inherited conditions globally, affect about 7% of the population as carriers, with 2.7% of newborns being born with these conditions. The spectrum of clinical manifestations... Read more

Immunology

view channel
Image: The novel test uses an existing diagnostic procedure as its basis to target the Epstein Barr Virus (Photo courtesy of 123RF)

Blood Test Measures Immune Response to Epstein-Barr Virus in MS Patients

Multiple sclerosis (MS) is a chronic neurological condition for which there is currently no cure. It affects around three million people globally and ranks as the second most common cause of disability... Read more

Microbiology

view channel
Image: The T-SPOT.TB test is now paired with the Auto-Pure 2400 liquid handling platform for accurate TB testing (Photo courtesy of Shutterstock)

Integrated Solution Ushers New Era of Automated Tuberculosis Testing

Tuberculosis (TB) is responsible for 1.3 million deaths every year, positioning it as one of the top killers globally due to a single infectious agent. In 2022, around 10.6 million people were diagnosed... Read more

Industry

view channel
Image: For 46 years, Roche and Hitachi have collaborated to deliver innovative diagnostic solutions (Photo courtesy of Roche)

Roche and Hitachi High-Tech Extend 46-Year Partnership for Breakthroughs in Diagnostic Testing

Roche (Basel, Switzerland) and Hitachi High-Tech (Tokyo, Japan) have renewed their collaboration agreement, committing to a further 10 years of partnership. This extension brings together their long-standing... Read more