Welcome to Dx Digest, where FierceMedicalDevices highlights the highs and sometimes lows of the past week in the diagnostics industry. LabCorp rolled out its recently approved DNA-based test for colorectal cancer. Illumina revealed results from a study showing that whole exome sequencing (WES) can improve diagnosis for children with white matter disorders, a genetic disease of the central nervous system. Last but certainly not least, a startup at Boston's Brigham and Women's Hospital is developing a quick way to diagnose brain disease. Read on for the details. And as always, feel free to contact us with any comments or questions. -- Emily Wasserman (email | Twitter)
LabCorp launches DNA-based test for colorectal cancer
Testing giant LabCorp ($LH) rolled out its DNA-based test for colorectal cancer screening. The FDA signed off on the diagnostic last month, making it the first DNA-based blood test for colorectal cancer approved by the agency.
LabCorp developed its Epi proColon test with Germany's Epigenomics and will market the product in North America through an agreement with Polymedco. The test works by screening for a proprietary DNA methylation biomarker for colorectal cancer in cell-free DNA circulating in the blood, the company said in a statement.
The test enters the market at a critical moment. More than 134,000 new cases of colorectal cancer are diagnosed each year, according to data from the American Cancer Society cited by LabCorp. The company's test offers another option for patients who do not want to undergo stool testing or colonoscopy.
"Many people are not properly screened because they are reluctant to collect a stool sample or undergo a colonoscopy," LabCorp CMO Dr. Mark Brecher said in a statement. "Tested from a simple blood draw, Epi proColon is a convenient, accurate alternative for those patients who should be screened for colorectal cancer." Statement
Illumina-backed study reveals positive results for whole exome sequencing
Whole exome sequencing (WES) may help improve diagnosis for white matter abnormalities in children, according to results from a new study from Illumina ($ILMN).
The sequencing giant worked with Children's National Health System and the University of Queensland to see whether WES would be able to diagnose unresolved cases of children with the disorder, which affects the central nervous system.
Researchers found that adding WES to diagnostic tools already used to screen for the disorder may decrease the number of unresolved cases from 50% to less than 30%. "Taking into consideration the clinical and psychosocial costs of prolonged diagnostic odysseys in these families, this is substantial," the scientists said in a statement.
The team recently published their findings online in the Annals of Neurology. Release | More
Brigham startup aims for quick brain disorder diagnosis with new tech
A startup that grew out of Brigham and Women's Hospital's Innovation Hub is making headway on developing a faster way to diagnose brain disease. The company, called BrainSpec, is kicking off clinical trials and looking for seed funding to take its efforts to the next level, the Boston Business Journal reports.
BrainSpec's technology includes software that can analyze brain chemical measurements from MRIs. The system produces an easy-to-understand readout that could help simplify diagnosis for doctors.
"This software will allow us to take (processing a patient) from three days to three minutes," Alex Lin, founder of BrainSpec and a director of the Center for Clinical Spectroscopy at Brigham and Women's, told the newspaper. "That's the reason we felt this was something we needed to develop. We have a backlog of patients." Story