Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine
Issue link: https://clinicalomics.epubxp.com/i/898657
22 Clinical OMICs November/December 2017 www.clinicalomics.com in all of the blood and urine samples provided by nine such patients. The test also directly determined the mutant allele frequency, a step that is essential for determining treatment for these types of cancers. The results from the MoM analy- ses were confirmed by qPCR. Others are also racing to get more POC molecular tests on the market. The Spartan Cube is an FDA-cleared, pint- sized, DNA diagnostic. It is based on qPCR, only requires a cheek swab, and delivers results in less than 60 minutes. Doctors are already being reimbursed for using the Cube for CYP2C19 gene analysis, which influences drug metab- olism. The test can also be used by non-medical staff, such as building managers who want to test for Legionella bac- teria, which can arise in buildings of all types and causes over 18,000 hospitalizations per year, 10% of which end in fatalities Home Alone OMICs Direct-to-consumer testing is also a growing field, and now patients are increasingly bringing their results to their doc- tor 's office. It's a twist on POC, where the patient delivers the results rather than the doctor or his assistant. And now it's up to the doctor to respond. Yet, there are a number of companies targeting consumers with such tests. According to Pathway Genomics CEO Michael Nova, the direct-to-consumer market will be several billion dollars within a few years. Pathway sells most of its tests through physicians now, but he anticipates growing consumer demand. "We have over 20,000 physicians who order our tests repeatedly," he said. The company also has partner- ships with retail clinic providers such as CVS, Meijer, Jet. com, and Walmart, as well as with IBM in conjunction with the Watson AI initiative for POC applications. Pathway's tests are based on traditional genetics but also incorporate data from health records, wearables and other sources, such as reimbursement claims. The company cur- rently markets POC diagnostics for response to medica- tions for pain and mental health, as well as a Cardiac DNA Insight test, but Nova also anticipates growth in testing for chronic diseases such as type 2 diabetes, obesity, and other wellness-related products. "There are many people who think obesity will soon become the biggest cause of cancer," Nova said. Helping people find the optimal diet and exer- cise, based on their genetics, could thus be a cornerstone of wellness. Color does target consumers—although their tests must be physician ordered—but also sells directly to physicians, has a research arm and works with self-insured employers. Their first test panels, which are all based on next gen- eration sequencing, are for common hereditary cancer and hereditary high cholesterol. One of Color 's strategies is to offer these tests at com- petitive rates—between $100 and $249. If someone tests pos- itive for any high-risk genes, the company also offers to test family members at a much reduced price. One problem Color is trying to address, said CMO Jill Hagenkord, is women who should be getting a BRCA test but can't because insurance does not consider them at high (continued from previous page) "One of the biggest developments has been a continued push for decentralization of healthcare. That trend has had a dramatic impact on the diagnostics field overall, and POC in particular." —Harry Glorikian, healthcare and life sciences consultant Basil Leaf Technologies founder, CEO, and CMO Basil Harris holds the DxtER device that won the $10 million Qualcomm Tricorder XPRIZE in 2017. (continued on page 24)