NEW YORK ─ The US Food and Drug Administration has issued a warning letter to KBMO Diagnostics, demanding that the firm cease selling an unapproved, uncleared, and unauthorized product for mitigation, prevention, treatment, or diagnosis of COVID-19.
KBMO's website states that its product uses at-home blood sample collection for COVID-19 serology testing, the FDA said in a warning letter to the firm dated June 17.
The agency further noted that KBMO stated its Blood Spot fingerstick test has been released and doctors can order it, and that it "will send a fingerstick test [collection kit] to the home of the patient," who will use United Parcel Service (UPS) to send a dry blood spot card to the KBMO laboratory.
The firm's website also includes a "BloodSpot Collection Tutorial Video" that shows people how to self-collect a blood sample at home and provides directions about mailing the sample, the FDA said. However, sample collection in the home versus in a healthcare setting presents potentially serious public health risks, the agency noted.
"You should take immediate action to correct the violations cited in this letter," the warning letter said, adding that failure to immediately correct the violations could result in legal action, including seizure and injunction.
As of June 29, KMBO's website no longer contained all of the statements cited by the FDA.
In an email to 360Dx, KMBO's CEO James White said the firm has validated its C-19 serology test at its CLIA-certified high-complexity laboratory. The letter from the FDA "was more about a number of our clients who took it upon themselves to advertise at-home sample collection and testing, which is not what we have been doing," he claimed. "Venipuncture samples are collected and sent to our laboratory for processing under CLIA high-complexity guidelines."
At its website, the firm states that blood-draw kits "require a phlebotomist either at your provider’s office or we can provide mobile phlebotomy services to come to your home as specified by your provider." The website also has a banner entitled COVID-19 Order Form for Patients, but an associated form is not available.
The FDA has been monitoring at-home collection for coronavirus lab testing as well as companies offering tests done in the home from sample to result. So far, it has authorized some tests for use with self collection, but it hasn't authorized any tests that can be done in the home from sample to result.
In March, the FDA had warned consumers about fraudulent at-home COVID-19 test kits.