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MultiGen said its test identified and confirmed the BRAF p.V600E mutation with a thousandfold increase in sensitivity compared to competing PCR-based and NGS methods.
While molecular testing is now routine in cancer and women's health, for other disease areas, the technology may be overkill, Sundin said.
The combination test will allow clinicians to analyze breast cancer patients for germline hereditary cancer markers at the same time as they search their blood for driver mutations.
In a conference call to discuss the firm's fourth-quarter and full-year earnings, senior management highlighted recent developments and outlined expectations for 2017.
Biopharma revenue grew from $14.1 million to $19 million in the quarter while clinical testing revenue declined from $12 million to $9.8 million.
Under the PIPseq program, Columbia University researchers sequenced the exome, transcriptome, or a gene panel in tumors of 101 high-risk pediatric cancer patients.
The company is planning to work with up to 40 sites, with an initial goal of sequencing circulating cell-free DNA from 10,000 people.
Based on the results, the researchers, based in Toronto, have initiated a clinical study in Ontario, called OCTANE, that involves a number of cancer centers in the province.
The company reported $29.4 million in revenues for the quarter and a net loss of $31.3 million, while the number of clinical tests increased to 11,627.
Under the agreement, researchers can use Foundation Medicine's assays to select patients eligible for Sarah Cannon Research Institute's clinical studies.