Topic:

Diagnostics

Latest Headlines

Latest Headlines

Foundation Medicine ditches plans to raise $150M

The bearish market that led Lombard Medical to delay its IPO and TriVascular Technologies to price below its range has scuttled a fundraise from diagnostics luminary Foundation Medicine.

Qiagen puts up $10M to boost its diagnostics manufacturing

Molecular diagnostics company Qiagen will invest $10 million to build out manufacturing capabilities at its Germantown, MD, campus by early 2015, focusing on products for women's health and infectious disease.

Abbott wins FDA nod for diabetes blood test

Abbott Laboratories has secured the FDA's blessing to launch its latest diabetes diagnostic, a test that can help diagnose and monitor diabetics as well as flag patients at risk for developing the disease.

SQI snags $4.2M to dial up its marketing push

SQI Diagnostics has raised $4.2 million through a public offering, selling off shares and warrants to bankroll its commercialization plans.

Adaptive Biotechnologies raises $120M to bolster its immune Dx

Seattle-based Adaptive Biotechnologies announced April 7 that it has completed two rounds of financing, netting the company $120 million that it will use to expand sales of existing products and develop new ones. 

Merck KGaA signs on to sell Auxogyn's IVF test

Germany's Merck KGaA signed a licensing agreement with Menlo Park, CA-based Auxogyn to sell its fertility-enhancing diagnostic test in Europe and Canada with an option to extend the agreement to other countries.

Exact Sciences raises $120M to get its cancer test on the market

A week after swaying an FDA panel with its colorectal cancer test, Exact Sciences raised $119.7 million through a stock offering, flipping 10 million shares at $12.75 each.

Roche snags diagnostics outfit IQuum in $450M deal

Roche is beefing up its point-of-care molecular diagnostics offerings, signing a deal to acquire Marlborough, MA-based IQuum for $275 million up front and up to $175 million in milestone-based payments.

Myriad wins, and investors cheer, at CMS's move to reduce coverage cuts for BRCA tests

Myriad Genetics had warned that CMS reimbursement for its BRCA predictive cancer tests could drop by close to 50% this year. Payments are indeed declining, but the Utah diagnostics company disclosed in a recent regulatory filing that they won't drop nearly as much as previously expected.

Four months later, 23andMe's clash with the FDA remains unresolved

In the four months since 23andMe agreed to stop selling all health-related genetic tests in the U.S. while it submits them for a formal FDA review, the California company's future has become cloudier, not clearer.  A recent blog post on its web site informed customers that executives continue to meet with regulators, but a resolution to the matter doesn't appear to be anywhere close to happening.