How to Avoid a Laboratory Audit

By Sean McSweeney  bio Laboratory audits have a much harder impact on your lab than intended. As detailed by the NCBI, the audit's intent is to review and assess laboratory performance to … [Read more...]


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

Thermo Fisher Scientific and Invitae were among the firms releasing multiple new products from the end of June through the third week of July. Here's a more complete rundown for the period: NEWLY … [Read more...]


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...]


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...]


Investment Trends: Venture Capitalists Remain High on Healthcare

Healthcare startups remain highly attractive to venture capitalists drawing $10.6 billion in investments in the first half of 2018, the most of any industry sector other than internet companies and … [Read more...]


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

After last month’s flurry of transactions, business calmed down as it often does during the start of summer. Here are the key deals and trends from mid-June through the third week of … [Read more...]


PAMA Unlocks Golden Age for Innovative Diagnostics

By Chance Scott  bio The publication of the 2018 Clinical Laboratory Fee Schedule (CLFS) in January saw a long and heated debate within the lab community come to fruition. When Congress … [Read more...]


DX Earnings Report: PAMA Cuts Make Little Dent on Q1 Lab Earnings

One quarter into its existence, the new PAMA Medicare Part B fee schedule seems to be having only a marginal impact on at least publicly traded labs. In fact, the recently published Q1 earnings … [Read more...]


Laboratory Information Systems (LIS): What You Need To Know To Get Paid

By Sean McSweeney  bio Today, laboratory billing claims require more and more data to successfully get paid. One of the biggest reasons your claims may be getting denied is because you're … [Read more...]


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

Here's a rundown of the key diagnostic product launches from mid-May through the third week of June: NEWLY LAUNCHED PRODUCTS & SERVICES Company(ies) Product(s) New England Biolabs … [Read more...]