Welcome to Dx Digest, where FierceMedicalDevices highlights the highs and sometimes lows of the past week in the diagnostics industry. Roche had a busy week, scoring FDA approval for its viral load tests and cobas 6800/8800 testing systems and posting stellar sales for its molecular diagnostics unit. Sequenom struck another liquid biopsy clinical research deal, teaming up with the University of Colorado Denver to see how well its ctDNA test can monitor for response to treatment and relapse in melanoma patients. Last but certainly not least, Veracyte's vocal CEO, Bonnie Anderson, weighed in on the Centers for Medicare & Medicaid Services' proposed pricing changes for precision medicine tests. Read on for the details. And as always, feel free to contact us with any comments or questions. -- Emily Wasserman (email | Twitter)
Roche scores FDA approval for hep C tests, charts promising molecular Dx numbers
Testing titan Roche ($RHHBY) charted progress this week across the board. The Swiss company notched FDA approval for its two viral load tests for patients with chronic hepatitis B or hepatitis C and its cobas 6800 and 8800 systems. Roche is still waiting for the agency's word on its tests for HIV-1 and cytomegalovirus, which will round out its viral testing portfolio once they are approved. "These new systems will provide laboratories with solutions for routine molecular testing that offer excellent performance, unmatched flexibility and absolute automation," Roche Diagnostics COO Roland Diggelmann said in a statement.
The company also revealed positive numbers for its diagnostics division, with sales jumping 6% to 7.8 billion Swiss francs ($8 billion) for the first 9 months of 2015. Roche's tissue diagnostics business contributed to that haul with a 12% increase in sales. And the company's diagnostics division shows "very good momentum" overall, Diggelmann said in Roche's earnings call, setting the stage for more progress in the months ahead. Release | More
Sequenom joins with University of Colorado Denver for liquid biopsy research
Back in August, Sequenom ($SQNM) announced that it would team up with the UC San Diego Moores Cancer Center to see how well its liquid biopsy tool can screen cancer patients and match them to a suitable therapy. Now the company is planning to work with the University of Colorado Denver School of Medicine on a similar project, determining whether its ctDNA test can help find an appropriate treatment for patients and monitor their response to therapy over time. The partnership is one of many for Sequenom as it looks to bring its liquid biopsy test to market in 2016. "This is our first collaborative study focusing on melanoma, which expands the range of cancers and clinical care settings that we are exploring with this novel technology," Sequenom CMO Dr. Daniel Grosu said in a statement. "We are uniquely positioned to leverage our strong expertise in testing circulating cell-free DNA to move liquid biopsy from a research concept to routine clinical practice in oncology." Statement
Veracyte CEO rails against proposed CMS pricing rule
Last month, diagnostics companies struck back at the Centers for Medicare & Medicaid Services (CMS) after the agency proposed pricing changes for certain tests, potentially comparing diagnostics to a similar and often lower-cost product in an effort to cut costs. Veracyte ($VCYT) CEO Bonnie Anderson spoke out against the proposal at the time, saying that lower-priced tests can "differ significantly, both in technical performance and intended use." And now Anderson has more fighting words for the agency, railing against the CMS' pricing proposals at a recent advisory panel meeting.
The way Anderson sees it, Veracyte's Afirma Gene Expression Classifier test "is helping tens of thousands of patients avoid unnecessary thyroid surgery when their biopsy results are ambiguous," she said in a statement, allowing patients to forgo costly procedures and taxing daily hormone replacement therapy. The CMS should use a "gapfill" technique for pricing similar tests, Anderson said, which would allow local contractors to set prices for the tests each year. "We believe that to do otherwise would be a step backwards for innovation, which is at the core of personalized medicine," she said. Release