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clinical trial

BioSequence is looking to raise the profile of its genomic offering among clinicians, and to strengthen its case for reimbursement.

 

Next year, the company will submit regulatory filings for the drug in two molecularly defined indications and a next-generation sequencing companion diagnostic. 

The study, launched today, aims to evaluate the use of liquid biopsy and natural killer cell testing for the early detection of recurrent breast cancer.

The company expects the new trials to start this fall, and plans to submit to the FDA next year to get the agency's stamp of approval.

The firm said that prior to entering clinical trials, it also needs to reduce failure rates of a cassette that is part of the Verigene 2 test.

The trial aims to validate a biomarker panel that includes Volition's colorectal cancer test in a large asymptomatic population in support of US regulatory approval.

Researchers from the University of Illinois said their test may one day enable patients to identify sepsis at home and transmit test results immediately to a physician. 

The test measures quantities of white blood cells and CD64 on the surface of neutrophils, enabling the immune system's response to sepsis to be monitored. 

The researchers found that Cepheid's Xpert HCV viral load assay used at the point of care performed at levels comparable to a laboratory test.

The test, developed with Pfizer, could identify renal cancer patients who would experience recurrence, but not who would benefit from adjuvant Sutent.

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