INDUSTRY BUZZ

FDA Watch: Changes to CBER Email Policy May Affect Your Lab

Heads up to any lab that's subject to oversight by the CBER, i.e., the FDA agency responsible for regulating biological products for human use. The agency changed its email communications policy on … [Read more...]

PAMA

Medicare Reimbursement: Part B Lab Payments in Final Year before PAMA

Part B payments for lab tests in 2017, the final year under the old reimbursement rules, totaled $7.1 billion, up slightly from the $6.8 billion Medicare paid in 2016 and little changed over the … [Read more...]

INDUSTRY BUZZ

FDA Watch: New LDT Proposal Is Much Different from One Negotiated with Industry

The lab industry played an active role in the drafting of the Diagnostic Accuracy and Innovation Act (DAIA), a bill designed to establish a new regulatory regime for laboratory developed tests (LDTs). … [Read more...]

TECHNOLOGY

Artificial Intelligence: An Automated New World for Labs & Pathology

Artificial intelligence (AI) and machine learning are making significant inroads in the diagnostics realm. Here are four ways the technology is changing the field and the business of pathology. 1. … [Read more...]

INDUSTRY BUZZ

FDA Watch: Agency Confirms that LOINC Coding of IVD Tests Is Voluntary

On June 15, the FDA issued a new guidance document clarifying the rules for laboratory coding of in vitro diagnostic tests. There are four key takeaways for IVD test makers and labs: 1. No … [Read more...]

DOJ

Industry Buzz: Criminal Charges May Spell the End for Theranos

Four years ago, Theranos was a $10 billion company poised to turn a breakthrough blood testing technology into a diagnostics dynamo to the tune of $70 billion in annual sales. Today, the company and … [Read more...]

INDUSTRY BUZZ

FDA Watch: Agency Offers a Modicum of Relief on DTC Marketing of Genetic Tests

Last November, the FDA raised eyebrows with a notice for public comment proposing to make it easier to bring new genetic health risk (GHR) assessment tests to market. The message to GHR test … [Read more...]

HEALTH INSURANCE

Industry Buzz: LabCorp and Quest Swept Up in Insurance Contract Partner Swap

Can you imagine Scarlett and Rhett swapping partners with Romeo and Juliet? Something like the laboratory industry equivalent of that scenario took place on May 25 when two of the nation's largest … [Read more...]

ACCREDITATION

Top of the News: ANDE Rapid DNA Platform First to Win FBI Approval

"Great news! The FBI just called." --Extremely rare phrase almost never uttered except sarcastically One of the very few exceptions to the above principle is ANDE (previously known as NetBio), a … [Read more...]

GENOMICS

Market Trends: Genetic Testing Becoming a Hot New Employee Benefit

While its clinical utility remains subject to debate, genetic testing has proven its value as an employment recruitment tool, especially on the West Coast where technology firms are leveraging its … [Read more...]


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