Welcome to Dx Digest, where FierceMedicalDevices highlight the highs and sometimes lows of the past week in the diagnostics industry. Quest Diagnostics launched hepatitis C test services that help doctors see how patients will respond to certain antiviral therapies. Foundation Medicine revealed new data from more than 1,200 pediatric cancers that could come in handy for developing new drugs for the disease. Last but certainly not least, Invitae got Medicare reimbursement for its multigene hereditary cancer tests. Read on for the details. And as always, feel free to contact us with any comments or questions. -- Emily Wasserman (email | Twitter)
Quest Diagnostics rolls out new hep C testing services
Drugmakers are rushing to market with new hep C therapies and Quest Diagnostics ($DGX) is capitalizing on the trend. The company recently expanded it hep C test services to include new tools that allow doctors to predict a patient's response to new therapies for the virus, including Merck's ($MRK) Zepatier and Bristol-Myers Squibb's ($BMY) Daklinza.
Quest's new services include testing for drug-resistant mutations associated with the virus in a subset of patients. The FDA recently approved certain therapies that inhibit those mutations, and Quest's tools help doctors see whether Zepatier work for patients with genotype 1a of the virus. Quest's new offerings also include tests that can automatically screen for NS5A drug resistance in patients who have genotype 1a.
"These new Quest services underscore the value of diagnostics to advance precision medicine," Quest's VP of R&D Rick Pesano said in a statement. "With insight into HCV NS5A status, the physician can better determine if the patient will not benefit from, or develops resistance to, an NS5A inhibitor, so an alternative treatment can be prescribed more quickly." Statement
Foundation Medicine unveils new data for pediatric cancer drug development
Foundation Medicine ($FMI) has been busy on the research front, and now, the company is revealing some of the fruits of its labor. Foundation recently touted data from more than 1,200 pediatric tumors that were analyzed with its genomic profiling tests that could help researchers develop new treatments for pediatric cancer.
The company collected genomic profiles from 1,239 pediatric tumors from individuals ages 0 to 18, and found genetic alterations that "offers significant discovery potential" and "can be used to generate hypotheses, validate rare findings, and investigate the genomic landscape of rare tumors in a pediatric population for which only small studies currently exist," Foundation said in a statement.
Some of the findings include genetic alterations spanning brain, sarcoma and hematologic cancer cases. The company's data also challenged "disease-specific" alterations found in certain genes, it said. Cambridge, MA-based Foundation presented its findings at the American Association for Cancer Research Annual Meeting 2016 in New Orleans. More
Invitae snags key Medicare reimbursement for hereditary cancer tests
Invitae ($NVTA) made strides on the payer front this week after getting Medicare reimbursement for its multigene tests for hereditary breast cancer-related disorders. Noridian, the Centers for Medicare and Medicaid Services' (CMS) administrative contractor for California, will pay for the tests, the company said.
Snagging Medicare reimbursement is a feather in Invitae's cap. The company has been working to get more private and public payers to sign onto its tests, so the recent news tips the scales more in its favor.
"We're pleased to announce that we are now getting paid by CMS, and we believe this decision sends an important message regarding the clinical utility and cost-effectiveness of multigene panels when applied in a medically responsible way based on peer-reviewed science and clinical guidelines," Invitae CEO Randy Scott said in a statement.
But Invitae's work is far from finished, Scott said. The company will "continue working with additional private payers to encourage similar adoption of a more transparent and modern coding and pricing policy based on state-of-the-art technology advances," Scott said. "There is no reason payers should be spending multiple thousands of dollars on genetic tests or paying for code stacking due to serial testing of multiple genes." Release