The FDA granted breakthrough device status to Prescient Metabiomics' Lifekit Prevent colorectal neoplasia test. Prescient Metabiomics is a subsidiary of Carlsbad, Calif.-based Prescient Medicine Holdings Inc.

Royal Oak, Mich.-based liquid biopsy startup Oncocell MDx Inc. reeled in $22.2 million in a series B financing led by Savitr Capital, with participation from existing investors. The company, which has raised a total of $30 million to date, plans to use the proceeds to support ongoing development of its pan-disease immunogenomics platform and commercialization of its novel noninvasive blood-based tests.

There have been three oncology drug approvals by the U.S. FDA over the last few years that were based solely on a genetic biomarker, rather than the location in the body where the tumor originated. But to make that tissue-agnostic approach a reality for oncology patients, detecting those genetic biomarkers will have to become increasingly easy and standardized.

There have been three oncology drug approvals by the U.S. FDA over the last few years that were based solely on a genetic biomarker, rather than the location in the body where the tumor originated. But to make this tissue-agnostic approach a reality for oncology patients, detecting those genetic biomarkers will have to become increasingly easy and standardized.

Baxter International Inc. has struck a definitive agreement to acquire Cheetah Medical Inc., a provider of noninvasive hemodynamic monitoring technologies. The Deerfield, Ill.-based company agreed to pay $190 million up front in cash, with the potential for an additional $40 million based on clinical and commercial milestones.

The U.S. FDA has granted breakthrough device designation to Laboratory for Advanced Medicine Inc. (LAM) for its liquid biopsy blood test for the detection of liver cancer. The test, which analyzes the DNA methylation pattern of cell-free DNA (cfDNA), is designed to detect the presence of hepatocellular cancer as early as stage 1, with both high specificity and sensitivity.

Concussion and traumatic brain injury (TBI) are serious public health problems, but they can be tricky to diagnose, with symptoms sometimes not presenting for days or weeks following a head injury. Abnormal eye movement can indicate a TBI, but traditional "follow my finger" screenings won't pick up more subtle changes in vision. Artificial intelligence (AI) could improve diagnosis by measuring deficits in certain eye movements that occur with a TBI. In a study published online July 25, 2019, in the journal Concussion, Bethesda, Md.-based Righteye Inc.'s FDA eye-tracking technology not only identified but scaled the severity of TBIs by measuring horizontal and vertical saccades, rapid eye movements between fixed points.