Cancer Detection Meets Portfolio Perfection: The ARKG ETF
Early cancer detection is an emerging frontier for healthcare companies. The
ARKG includes companies that merge healthcare with technology to capitalize on the revolution in genomic sequencing. These companies try to better understand how biological information is collected, processed, and applied by reducing guesswork and enhancing precision, restructuring health care, agriculture, and pharmaceuticals in the process.
“The Federal Drug Administration (FDA) recently granted Bluestar Genomics, a private company, a Breakthrough Device Designation for its liquid biopsy-based pancreatic cancer screening test,” writes ARK analyst Simon Barnett. “Stanford University researchers focusing on precision epigenomics founded Bluestar Genomics. Unlike those from GRAIL and Exact Sciences (EXAS), Bluestar’s tests focus on a biomarker called 5-hydroxymethylcytosine or 5hmC. 5hmC signals an epigenetic change in the genome that could
Share it
Liquid biopsy developers feature heavily in the latest round of FDA breakthrough designations, with Natera, Inivata and Bluestar Genomics all securing the status for their blood-based cancer tests.
Natera disclosed two breakthrough designations for its Signatera molecular residual disease (MRD) test. The designations provide a boost to Natera’s efforts to develop the circulating tumor DNA test through phase 3 trials as a companion diagnostic to two cancer medicines.
Texas-based Natera framed the FDA designations, which bring the number of Signatera breakthrough statuses up to three, as a reflection of progress in its cancer biopharma business. The unit has signed $65 million in contracts over the past year. Natera is yet to win FDA approval but it performs the test as a CLIA-certified laboratory.