Molecular POC Makes Strides

Molecular POC Makes Strides

Six companies to watch in the development of rapid and small footprint DNA testing near patient.


5 Trends to Watch in the Liquid Biopsy Market

5 Trends to Watch in the Liquid Biopsy Market

The liquid biopsy market is experiencing four trends driving growth, and one trend that should be watched as a limited trend.


Qiagen Adds to Leading Molecular Cancer Menu with FDA-Cleared JAK2 Test Kit

Qiagen Adds to Leading Molecular Cancer Menu with FDA-Cleared JAK2 Test Kit

The U.S. Food and Drug Administration (FDA) recently approved Qiagen’s ipsogen JAK2 RGQ PCR Kit for detection of the V617F mutation on the JAK2 gene associated with the myeloproliferative disorder polycythemia vera. The cancer test kit assists patient evaluation for the particular form of leukemia and is routinely tested in myeloproliferative neoplasms (MPNs) negative for mutation in the BCR-ABL gene. Kit availability for JAK2 testing will make the test more widely available to health systems for the implementation of personalized medicine for leukemia patients.


Molecular Diagnostics Faces Competition for Future Point of Care Testing in Developing World

Molecular Diagnostics Faces Competition for Future Point of Care Testing in Developing World

The sensitivity and specificity of nucleic acid analytes provide molecular diagnostics key advantages in clinical practice, particularly in critical health situations. Nucleic acid amplification (NAATs) or molecular tests are now open to routine and distributed use in healthcare thanks to advancements in microfluidics and molecular reagents. As molecular diagnostics enter point-of-care (POC) settings, cost becomes a key issue in comparison to predominantly used and cheaply performed rapid immunoassays.


Recent Autism Test Studies Add to Promising, Yet Inconclusive Research into Psychiatric Diagnostics

Recent Autism Test Studies Add to Promising, Yet Inconclusive Research into Psychiatric Diagnostics

In two recent studies, in vitro diagnostic (IVD) assays have been investigated that incorporate biomarkers for environmental factors and dysfunctional cellular pathways associated with autism spectrum disorders (ASDs). The accuracy of these oftentimes complex lab tests for ASD has improved with extensive genomic research into the disorder among large groups of ASD-affected families and between ASD and neurotypical siblings. While the clinical utility of a diagnostic lab test for ASD or ASD predisposition would be unquestionably high (particularly in young children and infants), additional research and assay validation across ASD populations is necessary to secure widespread clinical acceptance and payer coverage.


Test Guidelines Positive News for Cancer MDx Market

Test Guidelines Positive News for Cancer MDx Market

New guidelines on the use of biomarker-based tests for colorectal cancer are welcome news for test developers. We cover molecular-based cancer assays in our new report, The World Market for Molecular Diagnostics, 7th Edition.


New Therapies, Risk Factors Drive Hepatitis C Diagnostics

New Therapies, Risk Factors Drive Hepatitis C Diagnostics

This blog post discusses findings from Kalorama Information’s just-published market research report, The World Market for Molecular Diagnostics, 7th Edition (Infectious Disease, Cancer, NAT Blood Screening, Transplantation, Histology/Cytology, Inherited Diseases).

Clinical molecular diagnostics does not lack in targets. Dynamic expansion markets in point-of-care testing and cancer have headlined assay development efforts in recent years, but they are not the only major opportunities in molecular diagnostics.


Advanced Staining (IHC, ISH) in Clinical Diagnostics’ Genomic Age

The least glamorous and most labor intensive segment of clinical molecular diagnostic testing, histology and advanced stains such as in situ hybridization (ISH) and immunohistochemistry (IHC) endure even as their markets shift to other lab workflows and emerging IVD technologies.


Chinese Market Comes to the Fore in Cancer Diagnostics

Chinese Market Comes to the Fore in Cancer Diagnostics

In 2016, China is a clear market development priority for the IVD industry in the areas of cancer screening tests, companion diagnostics, and sequencing-based cancer assays.


Moonshot Initiative Promotes Next Generation of Molecular Cancer Diagnostics

Moonshot Initiative Promotes Next Generation of Molecular Cancer Diagnostics

Cancer is the common thread through several fronts of U.S. regulatory development, whether approval of targeted therapeutics; coverage and reimbursement decisions for advanced diagnostic laboratory tests (ADLTs); or expansion of FDA regulatory oversight over laboratory developed tests (LDTs). The disease is also a healthcare and research and development (R&D) focus of the Obama administration. Just as instrumental as cancer’s high societal burden and aging-driven rise in incidence, the proliferation of its genetic analytes and druggable targets has caught the attention of regulators.