FALSE CLAIMS

The End Comes for Theranos

Just five years ago, Theranos was a Silicon Valley sensation with a valuation of over $9 billion. While black-turtlenecked Elizabeth Holmes supplied the charisma, the heart of the Theranos phenomenon … [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...]

PUBLIC HEALTH

Toxicology Laboratories Play Key Role in Curbing the Drug Addiction and Opioid Epidemic

The National Independent Laboratory Association's (NILA's) Opioid Task Force is releasing a white paper entitled Curbing Drug Addiction and the Opioid Crisis: The Role of Toxicology Laboratories in … [Read more...]

NEW PRODUCTS

The Dx Pipeline: A Roundup of the Month’s Key New Product Launches

After a busy July, the pace and volume of new product launches slowed significantly in August. NEWLY LAUNCHED PRODUCTS & SERVICES Company(ies) Product(s) HTG Molecular … [Read more...]

NEW PRODUCTS

FDA Watch: Lab Industry Objects to Agency’s New LDT Proposal

On Aug. 3, the Food and Drug Administration heated the long simmering controversy over FDA regulation of laboratory developed tests (LDTs) to full boil by submitting a new proposal to Congress, … [Read more...]

REVENUES

DX Earnings Report: Q2 Lab Earnings Stay Strong but Not Quite at Q1 Levels

Q2 is shaping up to be another strong quarter—albeit not as stellar as Q1. Salient trends: Big labs continue posting impressive organic growth even as they enjoy the surge of new revenues from … [Read more...]

DISTRIBUTION AGREEMENTS

Diagnostic Deals: A Roundup of the Key Mergers, Acquisitions, Alliances, Licenses and Other Strategic Transactions From the Past Month

Forget the lazy days of summer–lab companies have been moving forward with deals. Here's a look at key activity from mid-July through the third week of August. M&A Roche acquired an additional … [Read more...]

SPECIAL FOCUS

Cost Avoidance vs Cost Savings: What’s the Difference?

By Jennifer Dawson, MHA, DLM (ASCP)  bio As I work to spread awareness within the clinical laboratory community about the Cost of Poor Quality (COPQ) concept and its benefits as a method to … [Read more...]

LAB SAFETY

Changes in laboratory waste management

By Dan Scungio, MT (ASCP), SLS, CQA (ASQ)  bio In the past, if a laboratory or a facility generated less than 220 pounds (or 100 kilograms) of hazardous (chemical) waste each month, it was … [Read more...]


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