Welcome to Dx Digest, where FierceMedicalDevices highlights the highs and sometimes lows of the past week in the diagnostics industry. Guardant Health is charting big plans for international expansion, nabbing a CE mark for its liquid biopsy testing kit and teaming up with Synlab Group's Labco Quality Diagnostics to distribute the test in Europe and South America. Genomic Health got a boost for its cancer tests, as clinical trials service organization Med Fusion revealed that it would include the company's multigene cancer diagnostics in its testing services. And Circulogene Theranostics is making more waves in the liquid biopsy space, announcing that it would use Station X's cloud-based genome management system to interpret data from its finger-stick cell-free DNA tests. Read on for the details. And as always, feel free to contact us with any comments or questions. -- Emily Wasserman (email | Twitter)
Guardant Health eyes international expansion with CE mark for liquid biopsy tests
Guardant Health has been making steady progress with its liquid biopsy testing technology, reeling in $50 million earlier this year to ramp up commercialization for its flagship product, Guardant360, and teaming up with Flatiron Health to build a cloud-based platform for drug development.
With some progress at home in tow, the Redwood City, CA-based company is setting sail toward other markets. Guardant recently scored a CE mark for its Guardant360 kit and has selected Synlab Group's Labco Quality Diagnostics to distribute the test in certain countries in Europe and South America. The company will launch its testing kit in Spain first and will process all test results at its CLIA-certified Redwood City lab. "We're excited to make Guardant360 more easily accessible to oncologists and patients around the world," Guardant CEO Helmy Eltoukhy said in a statement. "Cancer knows no borders. Obtaining a CE mark means Guardant360 can help more patients in more places." Release
Genomic Health finds more breadth for cancer tests with Med Fusion deal
Genomic Health ($GHDX) is looking for an expanded market for its cancer tests, and a deal with clinical trials service organization Med Fusion could give the company a boost. Med Fusion will add Genomic Health's Oncotype DX tests for breast, colon and prostate cancer to its molecular diagnostic test menu, helping doctors find the best treatment for patients and look for a risk of cancer recurrence.
The agreement also allows Med Fusion to cash in on a market ripe for growth, as doctors, payers and other healthcare providers look for personalized diagnostics that can optimize care and potentially reduce costs. "Our collaboration with Genomic Health support Med Fusion's model of creating and developing strategic relationships that complement our offering of personalized diagnostic testing services within a patient focused and supportive model of care delivery," Med Fusion CEO Jon Hart said in a statement. Statement
Circulogene Theranostics looks to the cloud for finger-stick liquid biopsy tests
Circulogene Theranostics has not wasted any time since launching its cell-free DNA liquid biopsy tests last month. A few weeks after rolling out its products, the company is teaming up with genome management outfit Station X to analyze and interpret test results on the cloud.
Birmingham, AL-based Circulogene will use Station X's GenePool platform to process patients' genomic information more quickly and provide customized reports to healthcare providers, allowing them to make more informed decisions about treatment. Circulogene already touts its finger-stick testing technology as faster and more cost-effective than standard liquid biopsy testing, and the company's partnership with Station X could help boost its reputation as an up-and-coming player in the liquid biopsy field.
"Station X has been instrumental in helping us build our genomic data analysis and reporting workflow," Circulogene CEO Mike Mullen said in a statement. "GenePool was the only solution with the flexibility and power to quickly analyze our unique sequencing data and generate reports that aid our clinician customers in planning, implementing and monitoring a patient's treatment process." Release