The company was founded with the vision to make “genetic testing and personalized medicine accessible and affordable to everyone.” Pathway Genomics’ testing services cover a variety of conditions including somatic & hereditary cancer risk, cardiac health, inherited diseases, nutrition and exercise response, as well as drug response. In addition to continual testing improvements and new testing developments, OME Care is also currently developing OME. OME is the “world’s only mobile healthcare consumer application with artificial intelligence to help provide consumers with personalized health and wellness information.
FDA Letters
In 2010, the pharmacy chain Walgreens put an agreement to sell Pathway's direct-to-consumergenetic test kits on hold after the United States Food and Drug Administration wrote Pathway a warning letter noting that the company had claimed that its test could identify persons at risk for multiple diseases, carrier status for several genetic diseases, and individual response to drugs, but that while the product "appears to meet the definition of a medical device| device", FDA had "been unable to identify any Food and Drug Administration clearance or approval number for" it and "request that you provide us with the FDA clearance or approval number". On September 10, 2015, Pathway announced "the launch of CancerIntercept, its first liquid biopsy, a non-invasive screening test designed for early cancer detection and monitoring, for as low as $299", which it said "detects mutations that are commonly associated with lung, breast, ovarian, colorectal cancers and melanoma, as well as mutations that occur less frequently in other cancer types." It marketed two versions of the test: CancerIntercept Detect "to detect tumor DNA in high-risk but otherwise healthy patients", and CancerIntercept Monitor for surveillance of "patients with active or previously diagnosed cancer." In response, FDA issued the company a warning letter stating that the test appeared to met the definition of a medical device, and that the agency had reviewed the medical literature and its own files but "have not found any published evidence that this test or any similar test has been clinically validated as a screening tool for early detection of cancer in high risk individuals", and that "It is unclear how the literature that cited , addressing the presence of circulating tumor DNA in already-diagnosed patients, is adequate to support the expansive claims of screening for early cancer detection using ctDNA in undiagnosed patients for up to 10 different cancers with the CancerIntercept Detect." American Cancer Society Deputy Chief Medical Officer J. Leonard Lichtenfeld, MD wrote a blog post critical of the company's announcement, saying that the state of the science would not allow one to tell from the discovery of such ctDNA what organ might be affected, what it might mean for prognosis or treatment of any patient, what additional diagnostic tests might be required to validate a positive finding, and other concerns. As of January 2019, Pathway Genomics was acquired by OME Wellness and re-named OME Care.
In 2014, IBM Watson Group announced its partnership with Pathway Genomics, to help “deliver the first-ever cognitive consumer-facing app based on genetics from a user’s personal makeup.” The mobile app, subsequently named OME, is the first of its kind to merge artificial intelligence and deep learning, powered by IBM Watson, with personal genetic information. It provides users with personalized health and wellness information based on the individual’s health history.
Executives
Pathway Genomics’ executives include Vadim Sulman, Michael Nova, M.D., Michael Druker and Michael H. Cox, CIPP.
