Here's a summary of the key product launches announced from late August through the third week of September, 2019: NEWLY LAUNCHED PRODUCTS & … [Read more...]
FDA WATCH
FDA Watch: New NGS Data Guidance May Ease Antiviral Drugs & Companion Test Approvals
October 21, 2019
A new FDA Technical Specifications document (Tech Doc) lists recommendations for sponsors on use of next generation sequencing data to secure approval of new antiviral drugs and related diagnostic … [Read more...]
Industry Buzz: Cologuard’s Wild September Ride
October 16, 2019
The month of September was a rollercoaster for a product that has in many ways become the face of the consumer genetic testing market, Exact Sciences’ Cologuard. The Growth of Cologuard The … [Read more...]
DIAGNOSTIC DEALS
Diagnostic Deals: A Roundup of the Key Mergers, Acquisitions, Alliances, Licenses and Other Strategic Transactions From the Past Month
September 30, 2019
After a brief summer lull, strategic deal making ramped up in September, especially in alliance making where volume nearly doubled last month’s levels. Here’s an overview of the long-term trends and … [Read more...]
CO-ORDINATING DATA
Laboratory Information Systems (LIS): What You Need To Know To Get Paid
September 30, 2019
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 not … [Read more...]
INDUSTRY BUZZ
FDA Watch: Agency Okays EIA Technology-Based Lyme Assays
September 30, 2019
Laboratory diagnosis of Lyme disease is based on detecting the presence of antibodies against Borrelia burgdorferi, the bacteria that causes the disease, in a patient's blood. Traditional testing uses … [Read more...]
EMERGING TESTS
Inside the Industry: Government Report Casts Doubt on Cost-Effectiveness of Leading Genetic Colorectal Cancer Screening Test
September 23, 2019
Few of the newfangled consumer genetic testing products have had greater commercial success and visibility than Exact Science's Cologuard colorectal cancer screening test. But a troubling new … [Read more...]
HUMAN RESOURCES
Are Erratic Scheduling Practices Causing Financial Instability for Your Hourly Lab Employees?
September 16, 2019
A study reveals that for today's hourly workforce, missing a single shift comes at a steep cost. New research from WorkJam, a digital workplace platform, found that for nearly half of employees … [Read more...]
NEW PRODUCTS
The Dx Pipeline: A Roundup of the Month’s Key New Product Launches
September 10, 2019
Here's a summary of the key product launches announced from late July through the third week of August, 2019: NEWLY LAUNCHED PRODUCTS & … [Read more...]
DIAGNOSTIC DEALS
Diagnostic Deals: A Roundup of the Key Mergers, Acquisitions, Alliances, Licenses and Other Strategic Transactions From the Past Month
August 29, 2019
Big picture-wise, health care industry mergers and acquisitions during the second quarter were up 7.3% from the first quarter and topped 250 deals for the eighth quarter in a row, according to … [Read more...]
