RESEARCH

The Year in Dx VC Investment: Dx/Tools Outperforms Health Care & Liquid Biopsy/AI/ Informatics Outperforms Dx/Tools

In a year that witnessed venture capital health care investment reaching an all-time high, diagnostics/tools (Dx/Tools) companies made out particularly well, according to Silicon Valley Banks' … [Read more...]

INDUSTRY BUZZ

Genetic Profiling: Study Casts Doubt on Cost-Effectiveness of Leading Breast Cancer Recurrence Assay

Among the many genetic profiling assays entering the commercial market, few have been more successful than Genomic Heath's Oncotype DX, which is now covered by most of the nation's biggest insurers. … [Read more...]

CAPITAL

Industry Trends: New Report Sheds Light on DX Tech Capital Flows

The health care industry has raised $5 billion in venture fund investment in the first half of 2017 and is well on pace to smash the single year record of $7.5 billion set in 2015, according to … [Read more...]

EMERGING TESTS

Sequencing-Based Screening Needed for Therapeutic Stem Cells

One of the potential therapeutic advantages of stem cells is that they can regenerate. But, a new study, published May 11 in Nature, suggests that the longer stem cell lines replicate the more … [Read more...]

FDA

FDA Reports Progress in Advancing Regulatory Science for Diagnostics

The U.S. Food and Drug Administration (FDA) recently unveiled its FY 2015-2016: Regulatory Science Progress Report. The report, the second of its kind under the Food and Drug Administration Safety and … [Read more...]

RESEARCH

Potential Upcoming Shifts for Diabetes-Related Diagnostic Testing

New research suggests that potential shifts might occur in diabetes-related testing, including potential increased use of point-of-care- (POC-) based hemoglobin A1c (HbA1c) testing for systematic … [Read more...]

GENETIC TESTING

Genetic Test Evaluation Framework to Aid Clinical Usefulness of Testing

Anew report by the National Academies of Sciences, Engineering, and Medicine provides a new decision framework for the use of genetic tests in clinical care. An Evidence Framework for Genetic Testing … [Read more...]

RESEARCH

iSpecimen Generates New Market for Discarded Biospecimens

iSpecimen (Lexington, Mass.) can be thought of as a cross between a dating site and an online marketplace for human biospecimens. The company has built a turnkey solution that connects providers, such … [Read more...]

RESEARCH

iSpecimen Creates Marketplace for Clinical Discards

iSpecimen (Lexington, Mass.) can be thought of as a cross between a dating site and an online marketplace for human biospecimens. The company has built a turnkey solution that connects providers, such … [Read more...]

FDA

CDRH Emphasizes Biomarkers and Precision Diagnostics in 2017 Priorities

Precision medicine and biomarkers can help the U.S. Food and Drug Administration (FDA) ensure safety of medical devices. That's according to the FDA Center for Devices and Regulatory Health's (CDRH) … [Read more...]


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