Welcome to Dx Digest, where FierceMedicalDevices highlights the highs and sometimes lows of the past week in the diagnostics industry. Myriad Genetics revealed positive study results for its melanoma test. GenomeDx Biosciences unveiled data showing that genetic information from a prostate needle biopsy can be used to predict how a patient's disease will progress. Last but certainly not least, Guardant Health said that it will work with cancer analytics company COTA to look at the cost benefits of using liquid biopsy testing on lung cancer patients. Read on for the details. And as always, feel free to contact us with any comments or questions. -- Emily Wasserman (email | Twitter)
Myriad Genetics touts promising results for melanoma test
Myriad Genetics ($MYGN) has been churning out study data demonstrating the potential of its cancer prognostic tests. The company this week added to its findings with positive data for its melanoma test.
In a second pivotal clinical validation study of 736 patients, Myriad's myPath Melanoma test diagnosed suspicious lesions with more than 90% diagnostic accuracy, 91.5% sensitivity and 92.5% specificity. The results match up with those from a first validation trial with 437 patients, which showed that Myriad's test had a diagnostic accuracy of more than 90%, the company said in a statement.
"myPath Melanoma is an extremely robust diagnostic test with unmatched clinical validity data, having completed the largest clinical validation study for a melanoma diagnostic test," Myriad Genetics' medical director Loren Clarke said in a statement. "We have now demonstrated in two pivotal validation studies that myPath Melanoma accurately differentiates patients with melanoma from those with benign moles." Statement
GenomeDx Biosciences trumpets data in favor of prostate needle biopsies
Liquid biopsy is picking up steam as a viable alternative to traditional biopsy testing. But GenomeDx Biosciences doesn't want people to forget about needle biopsy's potential. The company revealed results from a new study showing that prostate needle biopsies can flag genetic data that could predict how a patient's disease will progress.
San Diego-based GenomeDx and researchers from Cedars-Sinai Medical Center, the University of California, San Francisco (UCSF) and the University Health Network, Toronto, found that GenomeDx's Decipher Prostate Cancer Classifier test could pick up on signs of cancer progression from genetic material found in tumor samples. The study compared 158 samples from 33 men to get its results.
GenomeDx's findings could impact cancer prognosis. More than 800,00 men undergo prostate biopsy each year in the U.S., UCSF professor of clinical pathology Jeffry Simko said in a statement. The latest trial "increases confidence that reliable, quality genomic information can be obtained for those biopsies to better classify patient risk," Simko said.
"This study demonstrates that the Decipher score may be predictive of disease progression in diagnostic prostate needle biopsies and warrants a larger, adequately powered study to validate this observation," Simko said. More
Guardant Health taps cancer analytics firm for data on liquid biopsy tests
Liquid biopsy is growing by leaps and bounds, and Guardant Health wants to set itself apart from the pack. To do that, it's teaming with cancer analytics firm COTA to collect more data about cost and health benefits for its liquid biopsy tests.
The pair will look at how using Guardant's noninvasive tests in patients with non-small cell lung cancer (NSCLC) could cut costs and improve outcomes for patients. Individuals who are genotyped with the company's products might not need to go to repeat biopsies or deal with ensuing complications, Guardant said in a statement.
"With the costs of cancer care rising every year, patients, health systems and payers are all demanding better care at lower costs," Guardant Health CEO Helmy Eltoukhy said in a statement. "New technologies should not only push the envelope in terms of clinical utility, they should also provide greater value. We're excited about this partnership with COTA to help demonstrate this with real-world data." Release