In what represents its first patenting, San Diego-based Intrigue Health Inc. seeks protection for a diagnostic kit that its inventors say will bring clinical laboratory quality testing directly into the home and to non-health care facilities. They say their invention will enable consumers to move from symptom to treatment in hours from the convenience of where they are, which will lead to better health outcomes and much happier consumers.
The U.S. FDA handed good news to Healthy IO Ltd. (Healthy.io) with 510(k) clearance for its smartphone-based Minuteful Kidney test, making kidney function testing – from sample to result – possible at home. The app calculates the albumin-to-creatinine ratio (ACR), a key indicator of kidney disease. By enabling people to complete the test using their phones, the company says it has increased the rate of testing in high-risk patients by 50%.
The pandemic exponentially amplified the move to more patient-driven health care with at-home monitoring, wearable medical devices and telemedicine. Testing has arguably seen the greatest shift, led by emergency use authorizations (EUA) for dozens of rapid tests for SARS-CoV-2. Laboratory Corp. of American Holdings Inc. (Labcorp) stands to benefit even more from the trend with an EUA for an over-the-counter multiplex respiratory virus test and the launch of an at-home collection kit for testing hemoglobin A1c (HbA1c) this week.
Despite mandating earlier this year that private health insurance plans make over-the-counter COVID tests free to their subscribers, the U.S. CMS took until Feb. 3 to make the same benefit available to Medicare beneficiaries. The problem is that these tests will not be available to Medicare beneficiaries free of charge until “early spring,” the agency said, a point in time by which the latest surge of the pandemic is likely to have dissipated.
The availability of rapid antigen tests for the COVID-19 pandemic has been far short of ideal in recent weeks despite a recent order by the Biden administration for half a billion tests. The question of whether additional federal dollars are forthcoming for additional tests is up in the air, however, due to congressional concerns that there is roughly $800 million in unspent federal dollars, a signal that any additional monies might not be made available any time in the near term.
The COVID-19 pandemic has hit supplies and devices across a broad range of categories over the past two years, and the latest addition to the list is the blood collection tube. The FDA announced that this shortage affects all types of blood collection tubes, thus affecting tubes for all uses, not just those used for testing for the SARS-CoV-2 virus.
In a speech on Jan. 13, President Joe Biden revealed plans to purchase an additional 500 million at-home COVID-19 tests, bringing the total number the administration expects to provide for free to American households to 1 billion. In addition, Biden said the administration would distribute free “high quality masks.” On Wednesday, the administration said it would provide 5 million rapid COVID-19 tests and 5 million lab-based PCR tests to schools each month to support screening testing and test-to-stay programs.
The run on at-home COVID-19 tests may be for naught. The FDA warned that the popular rapid antigen tests recommended to keep New Year’s Eve revelers, relatives visiting elderly grandparents and workers exposed to the coronavirus from spreading COVID-19 are less likely to detect the Omicron variant than earlier strains of the virus. “Early data suggest that antigen tests do detect the Omicron variant but may have reduced sensitivity,” the agency said in an update on Dec. 29. Despite the higher rate of false negatives, the FDA said individuals should continue to use the tests. Those experiencing symptoms or with a high likelihood of infection based on exposure should follow-up with a molecular test if their antigen test returns a negative result.
As global demand for rapid testing soars due to a new variant of COVID-19, one company is shaking up the diagnostics market with an at-home rapid PCR solution. Founded in 2017 by scientist and entrepreneur Jonathan Rothberg, Detect Inc. is the developer of Detect COVID-19, a direct-to-consumer PCR test that provides results within one hour.
Becton, Dickinson and Co. (BD) completed its acquisition of Scanwell Health Inc., its partner in development of the smartphone-enabled BD Veritor At-Home COVID-19 Test, just in time for increased demand driven by the Omicron surge in the U.S. and plans to make the tests available for free by the federal government as well as several states and large municipalities. Currently, most of the tests distributed by governments are made by Abbott Laboratories, which received emergency use authorization (EUA) for its at-home test in March 2021.