NEW PRODUCTS

FDA Watch: New Process for Simultaneous Review IVD Tests Used in Cancer Drug Trials

Typically, in vitro diagnostic (IVDs) tests used in investigational cancer drug trials require two submissions: one for the IVD test and another for the drug. But on Oct. 9, the FDA issued final … [Read more...]

NEW PRODUCTS

The DX Pipeline: A roundup of the month’s key new product launches

With 10 days still left to run, October was shaping up to be the busiest month of 2019 for new product launches. Here’s a summary of the key diagnostic products unveiled so far: NEWLY … [Read more...]

NEW PRODUCTS

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

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

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...]

DIAGNOSTIC DEALS

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

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...]

INDUSTRY BUZZ

FDA Watch: Agency Okays EIA Technology-Based Lyme Assays

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...]

NEW PRODUCTS

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

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

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...]

SAFETY

Business Trends: Commercial Testing Companies ‘Sell’ Health Screenings

Several companies market an array of preventive tests directly to consumers. Are these companies and tests legit? What does the medical community have to say about such companies and advertising … [Read more...]

NEW PRODUCTS

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

A team led by Johns Hopkins Kimmel Cancer Center announced that it has developed a new test capable of determining whether patients with pancreatic cysts do or do not need surgery or further … [Read more...]


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