Welcome to Dx Digest, where FierceMedicalDevices highlights the highs and sometimes lows of the past week in the diagnostics industry. Foundation Medicine had a busy week, inking a companion diagnostics deal with pharma giant AstraZeneca and launching its liquid biopsy test. Seegene expanded its global presence with a new joint venture in Mexico. And Germany's Epigenomics got a pat on the back from Chinese regulators for its colorectal cancer test. Read on for the details. And as always, feel free to contact us with any comments or questions. -- Emily Wasserman (email | Twitter)
Foundation Medicine makes strides in companion Dx, liquid biopsy
2015 was an exciting year for Foundation Medicine after it struck a deal with test titan Roche ($RHHBY). But 2016 is shaping up to be pretty productive, too. Foundation recently struck a companion diagnostics deal with AstraZeneca ($AZN) and rolled out a liquid biopsy test, looking to cash in on two fast-growing testing markets.
Under the terms of its deal with AstraZeneca, Foundation will develop tests that can see which patients would benefit from drugs in the pharma titan's oncology pipeline. AstraZeneca will use Foundation's genomic profiling for solid tumors to enroll individuals in clinical trials of therapies that target the genetics behind the disease.
"This collaboration agreement, the fourth we have put in place with leading oncology companies, underscores the importance and potential of utilizing our rigorously validated, comprehensive profiling approach to make available to physicians an FDA-approved universal companion diagnostic solution for use with targeted medicines," Foundation COO Steven Kafka said in a statement. "We look forward to providing further updates as individual programs are initiated."
In other Foundation news, the company launched its liquid biopsy test, FoundationACT, this week. The tool analyzes circulating tumor DNA from a patient's blood to suss out certain genomic alterations. The information could help companies develop more targeted therapies and better match patients with clinical trials. Release | More
Seegene broadens global footprint with new Mexico JV
Seegene is striking out toward Mexico to kick off a new JV. The South Korea-based company will work with partner Biodist Group to spur adoption of molecular diagnostic technology in the rapidly growing Latin American market, which includes Mexico and other Central and South American countries.
Biodist and Seegene will each get a 50% stake in the new company, dubbed Biodist-Seegene Diagnostics. Seegene will lend its molecular diagnostic know-how and technology to the venture, and Biodist will provide marketing and sales expertise, the companies said in a statement.
But Mexico is not the only thing on Seegene's mind. The company is also planning to expand its business to include tests for nonhuman IVD markets such as agricultural and food safety testing, Seegene said in a statement. A stronger global reach could help the company achieve its goal. Statement
Epigenomics' colorectal cancer test gets regulatory distinction in China
Getting a pat on the back from China's regulatory authorities is no easy feat, as med tech companies know well. But Epigenomics is celebrating a recent victory after the country's FDA named its colorectal cancer test an "innovative medical product."
Only 9 out of 7,530 approved medical devices received this distinction, the German-based company said in a statement. The regulatory blessing is "excellent news" for Epigenomics, CEO Thomas Taapken said, as it brings its early colon cancer detection test to the Chinese market. More