Co-Diagnostics, Inc. Announces Intention to Submit Enhanced Version of COVID-19 Test to FDA for 510(k) Clearance
Co-Diagnostics (CODX) has announced the withdrawal of its current 510(k) FDA application for the Co-Dx™ PCR COVID-19 Test on the PCR Pro™, with plans to submit an enhanced version. The withdrawal follows FDA feedback regarding shelf-life stability concerns of a test component.
The company reports positive engagement with the FDA and satisfactory test performance in clinical evaluations. The decision to submit an enhanced version allows Co-Dx to address stability issues and incorporate recent platform developments, potentially improving operational and manufacturing efficiencies.
Moving forward, Co-Dx plans to submit the enhanced COVID-19 test for 510(k) OTC clearance after collecting new clinical evaluation data. The company's pipeline includes future tests for tuberculosis, upper-respiratory multiplex, and HPV. The Co-Dx PCR platform remains under regulatory review and is not yet available for sale.
Co-Diagnostics (CODX) ha annunciato il ritiro della sua attuale domanda 510(k) FDA per il test Co-Dx™ PCR COVID-19 sul PCR Pro™, con l'intenzione di presentare una versione migliorata. Il ritiro è avvenuto a seguito dei feedback della FDA riguardanti le preoccupazioni sulla stabilità della durata del test.
L'azienda riporta un coinvolgimento positivo con la FDA e prestazioni soddisfacenti del test nelle valutazioni cliniche. La decisione di presentare una versione migliorata consente a Co-Dx di affrontare le problematiche di stabilità e di incorporare recenti sviluppi della piattaforma, migliorando potenzialmente l'efficienza operativa e di produzione.
In futuro, Co-Dx prevede di presentare il test COVID-19 migliorato per l'approvazione 510(k) OTC dopo aver raccolto nuovi dati di valutazione clinica. Il pipeline dell'azienda include test futuri per tubercolosi, multiplex delle vie respiratorie superiori e HPV. La piattaforma PCR Co-Dx rimane sotto revisione regolatoria e non è ancora disponibile per la vendita.
Co-Diagnostics (CODX) ha anunciado el retiro de su actual solicitud 510(k) a la FDA para la prueba Co-Dx™ PCR COVID-19 en el PCR Pro™, con planes de presentar una versión mejorada. El retiro sigue los comentarios de la FDA sobre preocupaciones de estabilidad de la vida útil de un componente de la prueba.
La empresa informa de un compromiso positivo con la FDA y un desempeño satisfactorio de la prueba en evaluaciones clínicas. La decisión de presentar una versión mejorada permite a Co-Dx abordar problemas de estabilidad e incorporar desarrollos recientes de la plataforma, lo que podría mejorar la eficiencia operativa y de fabricación.
De cara al futuro, Co-Dx planea presentar la prueba COVID-19 mejorada para la autorización 510(k) OTC después de recopilar nuevos datos de evaluación clínica. La cartera de la empresa incluye pruebas futuras para tuberculosis, multiplex respiratorio superior y VPH. La plataforma PCR de Co-Dx sigue bajo revisión regulatoria y aún no está disponible para la venta.
Co-Diagnostics (CODX)는 PCR Pro™에서 Co-Dx™ PCR COVID-19 테스트에 대한 현재의 510(k) FDA 신청을 철회하고 향상된 버전을 제출할 계획이라고 발표했습니다. 이번 철회는 테스트 구성 요소의 유통 기한 안정성에 대한 FDA의 피드백에 따른 것입니다.
회사는 FDA와의 긍정적인 협력과 임상 평가에서 만족스러운 테스트 성능을 보고했습니다. 향상된 버전을 제출하기로 한 결정은 Co-Dx가 안정성 문제를 해결하고 최근 플랫폼 개발을 통합하여 운영 및 제조 효율성을 개선할 수 있는 기회를 제공합니다.
앞으로 Co-Dx는 새로운 임상 평가 데이터를 수집한 후 향상된 COVID-19 테스트를 510(k) OTC 승인 신청할 계획입니다. 회사의 파이프라인에는 결핵, 상부 호흡기 다중 검사 및 HPV에 대한 향후 테스트가 포함되어 있습니다. Co-Dx PCR 플랫폼은 여전히 규제 검토 중이며 아직 판매되지 않습니다.
Co-Diagnostics (CODX) a annoncé le retrait de sa demande actuelle 510(k) auprès de la FDA pour le test Co-Dx™ PCR COVID-19 sur le PCR Pro™, avec des plans pour soumettre une version améliorée. Ce retrait fait suite aux retours de la FDA concernant des préoccupations sur la stabilité de la durée de vie d'un composant du test.
L'entreprise rapporte un engagement positif avec la FDA et des performances satisfaisantes du test lors des évaluations cliniques. La décision de soumettre une version améliorée permet à Co-Dx de traiter les problèmes de stabilité et d'incorporer les récents développements de la plateforme, ce qui pourrait améliorer l'efficacité opérationnelle et de fabrication.
À l'avenir, Co-Dx prévoit de soumettre le test COVID-19 amélioré pour l'approbation 510(k) OTC après avoir collecté de nouvelles données d'évaluation clinique. Le pipeline de l'entreprise comprend de futurs tests pour tuberculose, multiplex des voies respiratoires supérieures et HPV. La plateforme PCR Co-Dx est toujours en cours de révision réglementaire et n'est pas encore disponible à la vente.
Co-Diagnostics (CODX) hat den Rückzug seines aktuellen 510(k) FDA-Antrags für den Co-Dx™ PCR COVID-19-Test auf dem PCR Pro™ angekündigt, mit dem Plan, eine verbesserte Version einzureichen. Der Rückzug folgt auf das Feedback der FDA zu Stabilitätsbedenken hinsichtlich der Haltbarkeit eines Testkomponenten.
Das Unternehmen berichtet von einem positiven Engagement mit der FDA und zufriedenstellenden Testergebnissen in klinischen Bewertungen. Die Entscheidung, eine verbesserte Version einzureichen, ermöglicht es Co-Dx, Stabilitätsprobleme anzugehen und aktuelle Entwicklungen der Plattform zu integrieren, was potenziell die betrieblichen und herstellerischen Effizienzen verbessern könnte.
Für die Zukunft plant Co-Dx, den verbesserten COVID-19-Test nach der Sammlung neuer klinischer Bewertungsdaten für die 510(k) OTC-Freigabe einzureichen. Die Pipeline des Unternehmens umfasst zukünftige Tests für Tuberkulose, obere Atemwegsmultiplex und HPV. Die Co-Dx PCR-Plattform befindet sich weiterhin in der regulatorischen Überprüfung und ist noch nicht zum Verkauf verfügbar.
- Clinical evaluations showed satisfactory test performance
- Opportunity to incorporate newer platform developments in the enhanced version
- Planned expansion of test portfolio to include tuberculosis, respiratory, and HPV tests
- Withdrawal of current 510(k) FDA application
- Shelf-life stability issues identified in test component
- Additional time and resources required for new clinical evaluation data
- Delayed market entry due to new submission requirement
Insights
The withdrawal and planned resubmission of Co-Diagnostics' COVID-19 test represents a complex strategic pivot with significant implications. The shelf-life stability issue, while technically addressable, signals potential challenges in the company's product development process. This setback occurs in a highly competitive diagnostic market where timing is crucial.
The decision to enhance the test while incorporating newer platform developments is strategically sound but carries important trade-offs. While it may result in a more robust product and streamlined manufacturing process, it will extend the timeline to market entry by several months, considering the need for new clinical evaluation data. This delay is particularly significant given the company's market capitalization of
The planned consolidation of manufacturing processes across the platform could yield substantial operational efficiencies and cost savings, potentially offsetting some development costs. However, this regulatory feedback might impact the development timeline of other pipeline products, including the tuberculosis and HPV tests, as similar stability considerations may need to be addressed across the portfolio.
From a technical perspective, shelf-life stability is important for diagnostic tests, affecting everything from manufacturing planning to inventory management and distribution logistics. The company's proactive approach to addressing this issue, while causing short-term delays, could strengthen their regulatory position for future submissions across their product pipeline.
The Company is withdrawing current submission based on FDA feedback related to shelf-life stability of a test component
Co-Dx is pleased with the productive engagement with the FDA related to the initial regulatory submission and with the performance of the test in clinical evaluations, including performance data and functionality of the instrument.
The decision by the Company to withdraw the submission was based on discussions with the FDA regarding the ability to detect a potential deterioration of one component of the test, related to shelf-life stability. Following dialogue with the FDA and exploring the various courses of action available, Co-Dx has determined that the best long-term solution would be to submit a version of the test that has been enhanced to address the matter raised in the 510(k) review process.
The Company plans to submit the next iteration of the Co-Dx PCR COVID-19 test for 510(k) OTC clearance, following the collection of clinical evaluation data to support the new test's performance. A new submission also allows the Company to incorporate more recent Co-Dx PCR platform developments into the COVID-19 test, which Co-Dx believes will also help to create greater operational and manufacturing efficiencies, such as consolidating manufacturing processes to utilize the next generation of test kits and instruments across all tests on the at-home and point-of-care platform.
The Company's primary objective is to execute a robust development and commercialization plan for the Co-Dx PCR platform, including ongoing innovations to the PCR Pro instrument. The Co-Dx PCR COVID-19 test is expected to be followed by additional tests for tuberculosis, upper-respiratory multiplex, and a multiplex HPV test, among others.
*The Co-Dx PCR platform (including the Co-Dx PCR Home™, Co-Dx PCR Pro™, mobile app, and all associated tests and software) is subject to review by the FDA and/or other regulatory bodies and is not available for sale.
About Co-Diagnostics, Inc.:
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Forward-Looking Statements:
This press release contains forward-looking statements. Forward-looking statements can be identified by words such as "believes," "expects," "estimates," "intends," "may," "plans," "will" and similar expressions, or the negative of these words. Forward-looking statements include statements made with respect to timing for submission of the next iteration of the Co-Dx PCR COVID-19 test for 510(k) OTC clearance, that streamlining the COVID-19 test will also help to create greater operational and manufacturing efficiencies, and our expectation that additional tests for tuberculosis, upper-respiratory multiplex, and a multiplex HPV test, among others, will follow. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. Forward-looking statements are subject to inherent uncertainties, risks and changes in circumstances. Actual results may differ materially from those contemplated or anticipated by such forward-looking statements. Readers of this press release are cautioned not to place undue reliance on any forward-looking statements. There can be no assurance that any of the anticipated results will occur on a timely basis or at all due to certain risks and uncertainties, a discussion of which can be found in our Risk Factors disclosure in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 14, 2024, and in our other filings with the SEC. The Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.
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SOURCE Co-Diagnostics
FAQ
Why did Co-Diagnostics (CODX) withdraw its FDA 510(k) application for the COVID-19 test?
What are the next steps for CODX's COVID-19 test FDA approval?
What other tests is CODX developing for the PCR Pro platform?
Is the Co-Dx PCR platform currently available for sale?
How will the new CODX test submission differ from the previous version?
