Genomic Health readies for liquid biopsy test launch; Foundation Medicine jumps on liquid biopsy bandwagon amid positive Q4 numbers

Welcome to Dx Digest, where FierceMedicalDevices highlights the highs and sometimes lows of the past week in the diagnostics industry. Genomic Health announced plans to roll out its liquid biopsy test in 2016. Foundation Medicine revealed positive Q4 numbers and talked up its liquid biopsy ambitions as competitors flood the field. Last but certainly not least, Qiagen expanded its companion diagnostics prowess through a deal with Array BioPharma, marking the company's 15th companion diagnostics collaboration to date. Read on for the details. And as always, feel free to contact us with any comments or questions. -- Emily Wasserman (email | Twitter)

Genomic Health shoots for liquid biopsy test rollout in 2016

Last year, Genomic Health ($GHDX) said that it would roll out its first liquid biopsy test in 2016, readying its sales force and ramping up its commercial channel for a launch. Now that moment is just around the corner, as the company announced recently that it would unveil its blood-based mutation test for cancer in mid-2016.

The test, dubbed Oncotype SEQ, relies on next-generation sequencing to pinpoint genetic alterations that indicate different types of late-stage cancer, including breast, lung, colon, melanoma and ovarian cancer. The product is the first of several liquid biopsy tests that the company plans to launch, Genomic said in a statement, as it builds out its portfolio beyond its gene expression tests for cancer.

"We believe we are well-positioned to lead this new market given our experience developing cancer tests that are optimized for clinical utility and patient access, along with our operational expertise and unmatched commercial channel," Genomic Health CMO Dr. Phil Febbo said in a statement. Statement

Foundation Medicine hypes liquid biopsy ambitions in Street-beating Q4

Foundation Medicine ($FMI) had a busy year in 2015, striking a $1.2 billion deal with Roche ($RHHBY) for cancer R&D and joining up with IMS Health ($IMS) to develop a new cancer diagnostics tool. Even though the company tripped a bit in light of sluggish reimbursement for its tests, that blip didn't seem to affect Foundation's end-of-the-year numbers. In fact, the company came out with its flags flying high and is setting its sights on liquid biopsy in 2016 to keep up the positive momentum.

Foundation brought in $26.1 million in revenue in Q4, beating the Street's estimates of $25 million. The company also trounced analysts' predictions for full-year revenues, raking in $93.2 million for the year ending Dec. 31, 2015. Analysts had pegged the company's full-year revenues a bit lower, at $92.3 million.

With recent progress in tow, the company is focusing on gaining ground in the liquid biopsy field. Foundation plans to launch its circulating tumor DNA test in the first quarter of 2016, it said in a statement, and is evaluating the test in an ongoing multicenter study to see which patients would benefit from the tool. More

Qiagen teams up with Array BioPharma in latest companion Dx deal

Qiagen ($QGEN) relies on companion diagnostic deals for its bread-and-butter business, and the company recently added to its deal vault by joining forces with Array BioPharma ($ARRY). The German diagnostics giant will work with Germantown, MD-based Array to develop a molecular diagnostic test for Array's Phase III melanoma candidate.

The deal, which marks Qiagen's 15th companion diagnostics collaboration with a pharma company, "holds the promise to improve outcomes for cancer patients," Qiagen CEO Peer Schatz said in a statement. "The fact that so many pharma and biotech companies have joined with Qiagen for these co-development projects … underscores the trust in our Sample to Insight solutions." Release