COMPLIANCE

Compliance Alert: FDA Warning Letter to Inova Genomics Laboratory

By Danielle Sloane¬†bio and Elaine Naughton¬†bio Despite it being a continual topic of discussion, the Food and Drug Administration ("FDA") enforcement in the realm of laboratory developed tests … [Read more...]

TOP OF THE NEWS

New Federal Taskforce to Speed Implementation of Emergency Use Diagnostics

Three federal agencies announced the creation of a new taskforce to provide timely recommendations to laboratories for rapid implementation of in vitro diagnostic (IVD) assays during public health … [Read more...]

TOP OF THE NEWS

Genetic Risk of Prostate Cancer Underestimated; Testing Guidelines Miss Men With Elevated Prostate Cancer Risk

Neither guideline eligibility nor Gleason scores are reliable for predicting prostate cancer risk due to pathogenic germline variants, according to a study published Feb. 7 in JAMA Oncology. The … [Read more...]

TESTING STRATEGY

New Studies Question Utility of Gene Expression Testing for Cancers With Unknown Primary Site, Low-Risk Breast Cancer

Gene expression profiling has been making inroads into clinical cancer care, with application in cancer classification, most notably with breast cancer. Two recent studies are calling into question … [Read more...]

INDUSTRY TRENDS

Diagnostics Sector Saw Increased Investment, Exits in 2018

Life science and health care companies had a banner year in 2018, with a record-breaking year for venture capital investment, according to Silicon Valley Bank's Trends in Healthcare Investments and … [Read more...]

PRECISION MEDICINE

Newborn Sequencing Delivers Some Unanticipated Findings

Newborn genomic sequencing (NGS) can identify risk for a wide range of disorders that otherwise may not be detected, even in seemingly healthy babies, according to a study published Jan. 3 in the … [Read more...]

LEGISLATION

New Broad All-Payor Kickback Law Impacting Laboratories, Commission-based Compensation and more

By Danielle Sloane bio and Chris Climo bio In a recent piece of federal legislation intended to address the opioid crisis across the United States, Congress enacted a new all-payor kickback … [Read more...]

GENETIC TESTING

Most Oncologists Report Using Sequencing-Based Panels In Practice

The majority of U.S. oncologists report using next-generation sequencing-based (NGS-based) tests to guide patient care, according to a study published Nov. 13 in JCO Precision Oncology, although use … [Read more...]

INFORMATICS

Big Data Can Reshape Lab Reference Values in the Era of Personalized Medicine

As might be expected, there are substantial differences in "normal" laboratory values determined by healthy outpatients and critically ill patients in the intensive care unit (ICU). However, even … [Read more...]

INDUSTRY TRENDS

Despite 23andMe Authorization, FDA Cautious About PGx Testing

The U.S. Food and Drug Administration (FDA) provided 23andMe (Mountain View, Calif.) authorization for the first direct-to-consumer (DTC) test for detecting genetic variants that may be associated … [Read more...]


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