Our Response to Subcommittee on Economic and Consumer Policy
We received a letter from Congress members Krishnamoorthi and Porter earlier this week regarding our COVID-19 online consultation and self-collection test service. We welcome the opportunity to share further information and details of our company’s effort to expand access to accurate and reliable testing in response to the COVID-19 pandemic.
We feel that it is important that the public also has the opportunity to read the entirety of the letter, which we have included below.
We are facing an unprecedented public health crisis with the COVID-19 pandemic. Like many other healthcare providers, we have been working to determine how we can leverage our substantial clinical, technical, and operational expertise to address this public health emergency.
We stand by, ready to help however called upon, and we will continue to explore ways to be supportive in the meantime.
The full text of our letter to Representatives Krishnamoorthi and Porter follows.
March 26, 2020
Chairman Krishnamoorthi and Representative Porter:
I serve as the Chief Executive Officer of Nurx and am writing in response to the Subcommittee’s March 24th request for further information about Nurx’s COVID-19 testing kit service. I welcome the opportunity to detail our company’s effort to expand access to accurate and reliable testing in response to the COVID-19 pandemic.
Nurx is a healthcare company that facilitates access to high-quality medical services from our licensed healthcare providers via a telehealth platform and integrated clinical, pharmacy and lab testing services. Nurx provides patients with medical consultations, as well as vital pharmacy and lab testing services, all from the safety, comfort and privacy of their own homes. Nurx specializes in providing care for sensitive healthcare conditions — including birth control, sexually transmitted infection testing, and HIV preventative support and related care.
As the first provider to offer comprehensive at-home testing and treatment for HIV prophylaxis (PrEP), our clinicians and CLIA-Licensed and CAP-Accredited lab partner — Molecular Testing Labs (“Molecular Labs”) — have deep experience in delivering a clinician-directed diagnostic process entirely through virtual care. Molecular Labs, recognizing the significance of the novel coronavirus’ spread in Wuhan, had the foresight to begin test development in mid-January. With due appreciation for the urgency of the coming public health crisis and out of a desire to leverage our substantial clinical, technical, and operational expertise to respond to the current and unprecedented global pandemic, Nurx worked tirelessly during March to develop an additional pathway to expand access to clinician-ordered tests at-cost and with no profit to our company.
On March 20th, we launched a COVID-19 home testing and online consultation service that allowed symptomatic and at-risk patients to be tested, have their results analyzed at a CLIA-Licensed high complexity lab, and consult with an experienced medical provider, all without having to leave their home. Less than one day later, on March 21st, following the release of an FAQ from the FDA that specifically addressed at-home, self-collection of specimens for laboratory testing for COVID-19, we stopped our COVID-19 service.
Before it issued the FAQ on March 21st, the FDA had not addressed whether samples self-collected at home pursuant to a clinician-order could be tested at a CLIA-Licensed laboratory complying with FDA guidance¹. Rather, the FDA’s guidance on COVID-19 diagnostics has been rapidly evolving and shifting to expand testing capacity. Our longstanding laboratory partner Molecular Labs followed the prevailing pathway towards authorization as authorized by the February 29, 2020 guidance from the FDA. Prior to the launch of our service, Molecular Labs validated the COVID-19 at-home collection test in accordance with the policy set out in the February 29, 2020 guidance.
As an alternative pathway to EUA submission, the FDA announced on March 16, 2020, that individual states could also authorize laboratories within their individual states “to develop their own COVID19 tests and perform specimen testing, where the notification of SARS-CoV-2 test validation is not submitted to the FDA and the laboratory does not submit an EUA request to FDA.”² Since Molecular Labs is a CLIA-Licensed high complexity laboratory and conforms to the regulatory requirements in its home state of Washington, its COVID-19 test was also permitted under this avenue.
After the FDA issued the FAQ on March 21st specific to self-collection laboratory testing, Nurx and Molecular Labs made the responsible decision to pause the COVID-19 testing and online consultation service until such time as the FDA provides guidance that self-collection is approved. Molecular Labs has been in communication with the FDA and the FDA has not expressed any accuracy concerns specific to Molecular Lab’s testing protocol or validation process. Neither Nurx nor Molecular Labs has reason to doubt the accuracy of Molecular Lab’s COVID-19 self-collection test given the sensitivity and specificity data collected to date. Molecular Lab’s assay is carefully designed to ensure that a proper self-collection has occurred.
With respect to the specific questions in the Subcommittee’s March 24th inquiry:
1. When did your company start offering at-home coronavirus test kits for sale to consumers, and when did you stop?
Nurx launched our COVID-19 testing and online consultation service on Friday afternoon of March 20th. Less than a day later, on Saturday, March 21, Nurx stopped offering our COVID testing and online consultation service to patients.
2. How many at-home coronavirus test kits did your company sell, how much did you charge, and how many consumers returned test kits with their samples?
Between March 20th and March 21st, Nurx sold self-collection testing kits to 181 patients that our providers had determined were appropriate for COVID-19 testing following an initial medical consultation. Only 103 of those tests were ultimately shipped to patients. As of March 25, 2020, 33 patients had returned test kits to Molecular Labs with self-collected samples, all of which were disposed of in accordance with governing biohazard disposal standards. Should more kits be received, they will be similarly disposed of by Molecular Labs.
Nurx offered our COVID-19 tests to patients at-cost and with no profit to our company. At launch, the total fee for the service was $181: $100 for the lab testing materials, lab work, platform administration and support; $35 for the medical consultation (which included unlimited test-related follow-up access to a medical provider); and $46 for overnight shipping both ways.
Both prior to and following launch of our COVID-19 service, we worked to further defray costs for patients and were in active conversations with public and private partners to try to help provide the testing service at a lesser fee or without charge where possible.
3. Do you intend to destroy all consumer samples received, and if so, when and how will you do so?
Consistent with governing regulatory guidelines, patients sent their self-collected samples directly to our partner lab, Molecular Labs. As of March 25, 2020, Molecular Labs had received 33 patient samples. Molecular Labs disposed of such patient samples in accordance with governing biohazard disposal standards. Nurx has instructed patients who had ordered self-collection kits but not yet submitted samples to discard their kits.
4. Do you intend to refund all consumers all amounts they paid for at-home coronavirus test kits, and if so, when and how will you do so?
On the first business day after we stopped our service, Monday, March 23rd, we began issuing full refunds to the 181 patients who would have received the COVID-19 testing kit. By Tuesday, March 24th all refunds were processed and completed.
5. How many nasopharyngeal swabs does your company possess, and will you donate them for use with FDA-approved coronavirus tests?
Nurx’s self-collection COVID testing kit included self-administered oropharyngeal (throat) swabs, which are less invasive than nasopharyngeal swabs and have been validated successfully by our partner lab Molecular Labs for self-collection of thousands of patient gonorrhea and Chlamydia test samples. Molecular Labs has invested considerable effort and resources correlating the accuracy of a variety of COVID-19 test specimen types and their research has found the accuracy of oropharyngeal swabs to be comparable to nasopharyngeal swabs.
Nurx does not have COVID-19 sample collection kits in its possession. All remaining components of unused self-collection COVID-19 test kits are in the possession of Molecular Labs. Our understanding from Molecular Labs is that at this time it has limited supplies of test components that are now being dedicated to IRB-approved research, and is experiencing similar supply challenges to those of the lab testing industry, health systems and government healthcare agencies. Molecular Labs is currently having on-going discussions with the FDA to gain EUA authorization for the use of self-collection as a viable alternative to physician-collection only.
Nurx agrees with leading public health authorities and the House Committee on Oversight and Reform³ that rapid and expansive testing is critical to both reducing and understanding the spread of COVID-19. We believe a successful and comprehensive testing strategy must include the triage and sample collection of patients in their homes, which will reduce possible exposure of others to the virus and alleviate the burdens faced by in-person healthcare providers. We are encouraged that the FDA recognizes that at-home sample collection can play an important role in addressing this pandemic and we hope they will soon issue further guidance so experienced providers like Nurx and Molecular Labs can help expand needed and appropriate testing.
We stand willing and ready to leverage our unique expertise and experience in response to the COVID pandemic and would welcome any opportunity to further work with the Subcommittee to expand testing capacity and access to care. I am happy to answer any further questions the Subcommittee might have or connect you with our experienced clinical team.
Sincerely,
Varsha Rao
¹ Prior to March 21st, as detailed above, the FDA’s sole references in its guidance to “home testing” were made in the context of commercial manufacturer development and distribution of tests prior to an Emergency Use Authorization (EUA) submission (Mar. 16, 2020 Guidance, Sec. C) and the use of serological testing without an EUA (Mar. 16, 2020 Guidance, Sec. D). Neither of those sections applied to how Molecular Labs validated and sought authorization for the COVID-19 at-home collection test. Additionally, the FDA’s restriction in these areas was with respect to “home testing,” which Molecular Labs test did not do. Their test allows for at-home collection; all testing is performed at a laboratory certified under CLIA to perform high-complexity testing. The totality of the information available to us on or before March 20 signaled that a COVID-19 at-home collection test was permissible. Indeed, the FDA’s March 20th press release did not change existing EUA guidance; rather it warned that the FDA was “monitoring firms marketing products with fraudulent coronavirus (COVID-19 diagnostic, prevention and treatment claims” and that the FDA “has not yet authorized any test that is available to purchase for testing yourself at home for COVID-19.” This statement did not change prior FDA guidance and did not appear applicable to lab tests with a clinician-directed home collection component.
² See FDA Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency, (March 16, 2020); see also Mar. 16, 2020 Statement of Admiral Giror, Corona Task Force Briefing, (“There are also a whole growth of what’s called laboratory determined testing or laboratory derived testing, where individual laboratories, because of the regulatory deregulation of the FDA, can develop their own tests and start using them. So if you’re a CLIA-certified lab with complexity, you can do that”).
³ Letter from U.S. House of Representatives Committee on Oversight and Reform to Secretary Azar and Dr. Robert Redfeld, (Mar. 19, 2020) (explaining that testing delays have prevented health officials from understanding the true scope of the crisis).
