Everlywell Announces COVID-19 $1M Development Incentive Program for Home-Collection Test
Self-collection from home is not only important for containment and limiting exposure, but also in the event our healthcare facilities are overloaded.
Last weekend, the FDA issued a new policy to help expedite availability of diagnostics to increase capacity for COVID-19 testing. Many laboratories around the country responded to that call, with Quest and LabCorp as the latest commercial labs to quickly develop a COVID-19 test that is collected in a clinical setting. Today, the University of Washington has announced support from the Gates Foundation for a home-kit option coming soon.
This is good progress, however, there is still a significant testing shortfall coupled with stringent, yet inconsistent, requirements for getting access to a test. With over 250,000 CLIA-certified labs in the U.S., Everlywell sees a significant opportunity to support test development for a home-collection setting.
Everlywell is uniquely positioned to assist during the COVID-19 crisis as one of the nation’s leading home testing companies, with relationships with nearly a dozen labs. Being able to self-collect from home is not only important for containment and limiting exposure, but also in the event our healthcare facilities are overloaded.
“As the COVID-19 public health emergency continues to worsen with community spread across the United States, there is an unmet medical need to broaden the access to testing for SARS-CoV-2 coronavirus in a responsible manner to complement and help alleviate the potential overload on healthcare systems and healthcare providers if testing was only available in the limited clinical setting,” said Dr. Frank Ong, M.D., Chief Medical and Scientific Officer of Everlywell.
We believe we have a responsibility to offer the Everlywell platform as part of the response plan for COVID-19 containment in the U.S. This platform includes an independent telemedicine group that can provide a positive diagnosis based on testing results and symptoms. Everlywell is already in talks with many labs around diagnostic test availability for a COVID-19 home-collection kit, and we believe it will be months before there is large-scale capacity and distribution. It’s imperative to move faster.
Today, Everlywell is issuing a call-to-action and will award a pool of up to $1M in development incentives for selected labs that can meet the following criteria and provide distribution to Everlywell for this panel in the next two to four weeks. To meet the FDA requirements for an LDT that is approved for testing use of COVID-19 detection, you must satisfy the following criteria:
- Certified by CLIA as a high-complexity lab and be compliant with all federal and state regulations
- Qualified as a P2 lab or higher as defined by the biosafety level (BSL) criteria set forth by the Center for Disease Control and Prevention (CDC)
- Must use either dried blood spot (require seven day stability), sputum, or nasopharyngeal swab collection methods that can be self-collected by the individual tester, not in a clinical setting
- Lab must have capacity to process a minimum of 5,000 samples per week for COVID-19 testing on existing platforms and be willing to expand capacity in partnership with Everlywell
- May be a molecular diagnostic-based assay (PCR) or other innovative technologies
- Meet the assay requirements specified here by the FDA, particularly the limit of detection, acceptance criteria, and cross-reactivity requirements
- Demonstrate robust sample quantification method for quality assurance and quality control pertaining to adequate viral genomic material from at-home collection methodology
- >99.9% correlation of results to established in-clinic collection methodology with False Negative rate of 0.01 or less with sample size of 120 or more subjects
- FDA notification upon the completion of assay validation and submission of Emergency Use Authorization within 15 days
What You Get as a Lab Partner:
- Up to $250,000 per lab in cash development incentives upon validation of criteria above which will be milestone-based
- Scalable kit production including nasal swab sourcing (or alternatives) and distribution by Everlywell nationally
- Expanded reach and market share due to Everlywell’s population reach and capabilities plus results platform
- Cash payment of lab fees within 30 days of test processing
Everlywell’s COVID-19 Testing Program:
- Online evaluation and ordering via the Everlywell Platform, including independent telemedicine physician review and diagnosis
- Real-time tracking for government agencies as to areas of perceived exposure
- Confirmation of diagnosis and federal and state health agency reporting via our independent telemedicine partners
- National supply chain for component sourcing, kit production, and deployment
- Partnership with state and federal authorities on self-quarantine programs
- Standard infectious biohazard material transport protocols
Please apply via submission form. All responses due by March 13, 2020, at midnight CT. Decisions made and communicated no later than March 20, 2020, at midnight CT. Final determinations for awards will be made upon successful determination of LDT readiness.
Everlywell believes people deserve access to affordable lab tests and insightful, digitally-enabled results with actionable next steps. The company connects consumers to laboratory partners offering more than 30 validated lab tests including Food Sensitivity, Fertility, Heart Health, STIs, and Thyroid. Test prices are straightforward starting at $39 and are generally covered by Flexible Spending and Health Savings Accounts. Physician-reviewed, actionable test results from CLIA-certified labs are provided within days of sample receipt.
The company was founded in 2015, is located in Austin, TX and backed by notable investors including Goodwater Capital, Highland Capital Partners, Next Coast Ventures and NextGen Venture Partners, among others. EverlyWell was selected as one of Fast Company’s Most Innovative Companies in 2019.