Intelligent Bio Solutions Partners with CenExel to Conduct Clinical Study as Part of FDA 510(k) Pathway
Intelligent Bio Solutions Inc. (Nasdaq: INBS) has partnered with CenExel to conduct a method comparison clinical study as part of its FDA 510(k) pathway. The study will recruit 135 healthy adults across three sites to compare fingerprint sweat opiate screening tests with LC-MS/MS results. This marks the final phase of INBS's clinical study plan, following the completion of a pharmacokinetic study on opiates in human fingerprint sweat.
CEO Harry Simeonidis stated that the company remains on track for its planned FDA submission in Q4 2024. The study aims to demonstrate the accuracy of the Intelligent Fingerprinting Drug Screening System in detecting opiates. The clinical trial is set to commence in August 2024, bringing INBS closer to its goal of providing rapid, non-invasive testing solutions.
Intelligent Bio Solutions Inc. (Nasdaq: INBS) ha stretto una partnership con CenExel per condurre uno studio clinico di confronto dei metodi come parte del suo percorso FDA 510(k). Lo studio recluterà 135 adulti sani in tre sedi per confrontare i test di screening degli oppiacei nel sudore delle impronte digitali con i risultati LC-MS/MS. Questo segna la fase finale del piano di studio clinico di INBS, dopo il completamento di uno studio farmacocinetico sugli oppiacei nel sudore delle impronte digitali umane.
Il CEO Harry Simeonidis ha dichiarato che l'azienda rimane in linea con la sua pianificazione per la sottomissione all'FDA nel quarto trimestre del 2024. Lo studio mira a dimostrare l'accuratezza del sistema di screening dei farmaci Intelligent Fingerprinting nel rilevamento degli oppiacei. La sperimentazione clinica inizierà ad agosto 2024, avvicinando INBS al suo obiettivo di fornire soluzioni di test rapidi e non invasive.
Intelligent Bio Solutions Inc. (Nasdaq: INBS) se ha asociado con CenExel para llevar a cabo un estudio clínico de comparación de métodos como parte de su ruta FDA 510(k). El estudio reclutará a 135 adultos sanos en tres sitios para comparar las pruebas de detección de opiáceos en el sudor de las huellas dactilares con los resultados de LC-MS/MS. Esta es la fase final del plan de estudio clínico de INBS, después de completar un estudio farmacocinético sobre opiáceos en el sudor de las huellas dactilares humanas.
El CEO Harry Simeonidis declaró que la empresa sigue en camino para su presentación planificada a la FDA en el cuarto trimestre de 2024. El estudio tiene como objetivo demostrar la precisión del Sistema de Detección de Drogas Intelligent Fingerprinting en la detección de opiáceos. El ensayo clínico comenzará en agosto de 2024, acercando a INBS a su objetivo de proporcionar soluciones de pruebas rápidas y no invasivas.
Intelligent Bio Solutions Inc. (Nasdaq: INBS)는 FDA 510(k) 경로의 일환으로 방법 비교 임상 연구를 수행하기 위해 CenExel과 협력했습니다. 이 연구는 3곳에서 135명의 건강한 성인을 모집하여 지문 땀에서 오피오이드 스크리닝 테스트를 LC-MS/MS 결과와 비교할 예정입니다. 이는 INBS의 지문 땀에서 오피오이드에 대한 약리학적 연구를 완료한 후 임상 연구 계획의 마지막 단계입니다.
CEO 해리 시메오니디스는 회사가 2024년 4분기에 예정된 FDA 제출 일정을 잘 지키고 있다고 밝혔습니다. 이 연구는 Intelligent Fingerprinting 약물 스크리닝 시스템의 오피오이드 탐지 정확성을 입증하는 것을 목표로 하고 있습니다. 임상 시험은 2024년 8월에 시작되며, INBS는 신속하고 비침습적인 검사 솔루션을 제공하려는 목표에 더욱 가까워질 것입니다.
Intelligent Bio Solutions Inc. (Nasdaq: INBS) s'est associé à CenExel pour réaliser une étude clinique de comparaison des méthodes dans le cadre de son processus FDA 510(k). L'étude recrutera 135 adultes en bonne santé dans trois sites pour comparer les tests de dépistage d'opiacés par empreinte digitale avec les résultats LC-MS/MS. Cela marque la phase finale du plan d'étude clinique d'INBS, après l'achèvement d'une étude pharmacocinétique sur les opiacés dans la sueur des empreintes digitales humaines.
Le PDG Harry Simeonidis a déclaré que l'entreprise reste sur la bonne voie pour soumettre son dossier à la FDA au quatrième trimestre 2024. L'étude vise à démontrer la précision du Système de Dépistage des Drogues Intelligent Fingerprinting dans la détection des opiacés. L'essai clinique devrait débuter en août 2024, rapprochant INBS de son objectif de fournir des solutions de test rapides et non invasives.
Intelligent Bio Solutions Inc. (Nasdaq: INBS) hat sich mit CenExel zusammengeschlossen, um eine klinische Studie zum Vergleich von Methoden im Rahmen des FDA 510(k)-Verfahrens durchzuführen. In der Studie werden 135 gesunde Erwachsene an drei Standorten rekrutiert, um Schweißproben von Fingerabdrücken auf Opiate mit den Ergebnissen von LC-MS/MS zu vergleichen. Dies stellt die letzte Phase des klinischen Studienplans von INBS dar, nach dem Abschluss einer pharmakokinetischen Studie zu Opiaten im menschlichen Fingerabdruckschweiß.
CEO Harry Simeonidis erklärte, dass das Unternehmen auf Kurs ist, um seinen geplanten Antrag bei der FDA im vierten Quartal 2024 einzureichen. Ziel der Studie ist es, die Genauigkeit des Intelligent Fingerprinting Drug Screening Systems bei der Erkennung von Opiaten nachzuweisen. Die klinische Studie soll im August 2024 beginnen und bringt INBS näher an sein Ziel, schnelle, nicht-invasive Testlösungen anzubieten.
- Partnership with CenExel, a nationwide clinical research site network, for the method comparison study
- Completion of the in-clinic portion of a pharmacokinetic study on opiates in human fingerprint sweat
- On track for planned FDA 510(k) submission in Q4 2024
- Progress towards demonstrating accuracy of the Intelligent Fingerprinting Drug Screening System
- None.
Insights
Intelligent Bio Solutions' partnership with CenExel for a method comparison clinical study marks a significant milestone in their FDA 510(k) pathway for the Intelligent Fingerprinting Drug Screening System. This study, involving 135 healthy adult subjects across three sites, aims to validate the system's accuracy in detecting opiates in fingerprint sweat compared to the gold standard LC-MS/MS method.
The study's design is robust and well-planned, adhering to FDA requirements for 510(k) submissions. The use of an IRB-approved protocol and comparison to a validated LC-MS/MS method enhances the study's credibility. The
However, investors should note that while the company is progressing towards its Q4 2024 FDA submission target, the 510(k) process can be unpredictable. The FDA's review time and potential requests for additional data could affect the timeline. Moreover, even with FDA clearance, market adoption of this novel technology may face challenges, including competition from established drug testing methods and potential resistance from current industry practices.
The completion of the pharmacokinetic study and the imminent start of the method comparison study in August 2024 indicate positive momentum. However, the true value of this technology will depend on its performance in real-world settings and its ability to address current limitations in drug screening processes.
The announcement of Intelligent Bio Solutions' partnership with CenExel for their FDA 510(k) clinical study is a positive development for the company's progress towards regulatory approval. This milestone could potentially impact the company's market position and financial outlook.
Key financial considerations include:
- R&D Expenses: The clinical study likely represents a significant portion of the company's R&D budget. Investors should monitor the burn rate and cash position to ensure sufficient funding through the FDA submission process.
- Market Opportunity: The global drug testing market is projected to reach
$11.7 billion by 2030, growing at a CAGR of5.2% . INBS's innovative fingerprint-based technology could capture a substantial share if approved and widely adopted. - Revenue Potential: While the company hasn't provided revenue projections, successful FDA clearance could lead to partnerships with healthcare providers, law enforcement agencies and employers, potentially driving significant revenue growth.
- Competitive Advantage: The non-invasive nature of the test could provide a competitive edge in the market, potentially commanding premium pricing.
However, investors should remain cautious. The company's Nasdaq listing is important for maintaining investor interest and access to capital markets. INBS will need to carefully manage its finances to maintain compliance with Nasdaq's listing requirements while pursuing FDA approval.
Overall, while the news is promising, the company's financial success will ultimately depend on FDA approval, successful commercialization and market adoption of its technology.
NEW YORK, Aug. 01, 2024 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) ("INBS" or the "Company"), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced its partnership with CenExel, a nationwide clinical research site network, to perform a method comparison clinical study as part of the Company’s FDA 510(k) clinical study plan.
The Company’s method comparison study will recruit 135 healthy adult subjects across three sites under an IRB-approved protocol and compare the results of fingerprint sweat opiate screening tests to the results from a validated, traceable liquid chromatography mass spectrometry (LC-MS/MS) method, widely accepted as the gold standard for such studies.
Harry Simeonidis, President and CEO of Intelligent Bio Solutions, commented, “We are pleased to announce our partnership with CenExel and the initiation of the method comparison study, marking the final phase in our clinical study plan. Over the past two months, we have made substantial progress and are steadily getting closer to filing our 510(k) submission with the FDA. We remain on track for our planned submission to the FDA in the fourth quarter of this calendar year. I commend our dedicated team and clinical study partners for their immense effort and commitment to ensuring the smooth execution of our clinical study plan.” Stuart Goldblatt, Chief Executive Officer at CenExel, stated, “CenExel is excited to commence this clinical trial to test this innovative device with the potential to provide rapid and non-invasive testing for opiates.”
The Company recently completed the in-clinic portion of a pharmacokinetic (PK) study on opiates in human fingerprint sweat. Through the method comparison study, the Company intends to demonstrate that the Intelligent Fingerprinting Drug Screening System, which comprises the Intelligent Fingerprinting Drug Screening Cartridge and DSR-Plus fluorescence reader, performs accurately in the hands of intended users to detect the presence of opiates. The Company plans to commence the method comparison study in August 2024.
About CenExel
CenExel provides unparalleled medical and scientific support in the design and execution of clinical trials. CenExel’s therapeutic area focus, attention to detail, and auxiliary services assure quality, reliable results and help it to consistently achieve and exceed patient recruitment goals. CenExel Centers of Excellence have conducted thousands of studies, the variety and complexity of which have resulted in a vast depth of experience and insight for the Principal Investigators and research staff in each facility. The CenExel Centers of Excellence deliver the engagement, expertise, and results to ensure clients achieve their clinical research goals.
About Intelligent Bio Solutions Inc.
Intelligent Bio Solutions Inc. (NASDAQ: INBS) is a medical technology company delivering innovative, rapid, non-invasive testing solutions. The Company believes that its Intelligent Fingerprinting Drug Screening System will revolutionize portable testing through fingerprint sweat analysis, which has the potential for broader applications in additional fields. Designed as a hygienic and cost-effective system, the test screens for recent use of drugs commonly found in the workplace, including opiates, cocaine, methamphetamine, and cannabis. With sample collection in seconds and results in under ten minutes, this technology would be a valuable tool for employers in safety-critical industries. Additionally, the Company's biosensor platform has the potential to test for various indications, ranging from immunological conditions to communicable diseases. The Company's current customer segments include construction, manufacturing and engineering, transport and logistics firms, drug treatment organizations, and coroners.
For more information, visit: http://www.ibs.inc/
Forward-Looking Statements:
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, Intelligent Bio Solutions Inc.'s ability to successfully develop and commercialize its drug and diagnostic tests, realize commercial benefit from its partnerships and collaborations, and secure regulatory approvals, among others. Although Intelligent Bio Solutions Inc. believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Intelligent Bio Solutions Inc. has attempted to identify forward-looking statements by terminology, including "believes," "estimates," "anticipates," "expects," "plans," "projects," "intends," "potential," "may," "could," "might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, included in Intelligent Bio Solutions' public filings filed with the Securities and Exchange Commission. Any forward-looking statements contained in this release speak only as of its date. Intelligent Bio Solutions undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Company Contact:
Intelligent Bio Solutions Inc.
info@ibs.inc
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Investor & Media Contact:
Valter Pinto, Managing Director
KCSA Strategic Communications
PH: (212) 896-1254
INBS@kcsa.com
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