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Palmetto has expanded the local coverage determination for the Guardant360 liquid biopsy assay to be used with the majority of advanced solid tumors.
The researchers used the Guardant360 assay and droplet digital PCR to identify genetic mutations in circulating tumor DNA that had been shed into the patients' bloodstream.
The liquid biopsy firm reported revenues of $60.8 million for the quarter, easily surpassing the consensus Wall Street estimate of $45.4 million.
News items for the week of Oct. 21, 2019
Of the 29 companies in the index, 16 firms' share prices retreated while the other 13 saw their stock prices rise month over month.
Industry experts say a receptive market and investor interest in new technologies have spurred the increase in genomics tools and molecular diagnostics IPOs.
In response to CMS reopening its national coverage determination to address its germline testing policy, stakeholders point out areas of concern and confusion.
The company is on track to submit Guardant360 to the FDA in the third quarter, but also expects to see pan-cancer reimbursement much sooner.
The company sold nearly twice as many tests as in Q2 last year, with clinical test revenue more than doubling and total revenue reaching $54 million for the quarter.
Guardant told a federal judge that it believes Foundation Medicine and Personal Genome Diagnostics are coordinating to invalidate its patents.