ENFORCEMENT

Theranos Faces Potential Consumer Fraud Litigation

The Arizona Attorney General's Office (AGO) recently issued a request for proposal signaling a new legal battle for Theranos: state consumer fraud lawsuits. The AGO indicated in its request that it … [Read more...]

PRECISION MEDICINE

Industry Leaders Recommend Standardized Interpretation and Reporting of Somatic Sequence Variants

Acommon refrain within the diagnostics industry is a need for standardization. Rapidly developing technology and testing methods, the call for interoperability, and the vast amount of data and … [Read more...]

PRECISION MEDICINE

Coalition Promotes cfDNA-based Noninvasive Prenatal Testing

Five major players in genetic testing have joined forces to promote cellfree DNA (cfDNA)-based noninvasive prenatal testing (NIPT). A newly formed organization, Coalition for Access to Prenatal … [Read more...]

ACCREDITATION

Lab Accreditation Updates

Two of the main accreditation organizations for laboratories, the Joint Commission and the College of American Pathologists, have issued some updates that labs need to be aware of for 2017: The … [Read more...]

FEE SCHEDULES

Crosswalked Codes in 2017 Clinical Laboratory Fee Schedule

CPT Code Crosswalked To 80305 (Drug tests(s), presumptive, any number of drug classes; any number of devices or procedures, (e.g., immunoassay) capable of being read by direct optical … [Read more...]

INSIGHT

The New Overtime Rules are Put on Hold. What Does That Mean for You?

By Mike O'Brien  bio As most of you know by now, I'm sure, the United States Department of Labor (DOL) has finalized a new Fair Labor Standards Act (FLSA) rule that, among other things, … [Read more...]

LDTs

No Final LDT Framework in 2016: FDA Seeks Further Input from Stakeholders, New Administration

The U.S. Food and Drug Administration (FDA) has provided laboratories with some much needed good news—the agency will not finalize its laboratory-developed test (LDT) guidance document before the end … [Read more...]

INNOVATION

Lab Institute 2016 Highlights:
Convergence, Compliance and Genetics

Attendees at G2 Intelligence's 34th annual Lab Institute were treated to a history lesson about diagnostics as well as forward-looking discussions that illuminated the current state and the future of … [Read more...]

INNOVATION

G2 Awards Recognize Diagnostics Leaders and Innovators

Amidst three days of networking, workshops, panel discussions and presentations focused on the challenges and opportunities facing laboratories and pathologists, two leaders in diagnostics were … [Read more...]

PUBLIC HEALTH

CDC and the Diagnostics Industry Continue to Battle Zika

While summer has ended, the battle against the mosquito-borne virus Zika continues. On Oct. 21, the Centers for Disease Control and Prevention (CDC) announced approximately $70 million will be made … [Read more...]


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