Intelligent Bio Solutions Concludes In-Clinic Testing for Clinical Study Plan, Advancing Toward FDA 510(k) Submission
Intelligent Bio Solutions Inc. (Nasdaq: INBS) has successfully completed in-clinic testing for its clinical study plan, a important step towards FDA 510(k) submission. The studies, including a pharmacokinetic (PK) study and a method comparison and usability study, aim to validate the accuracy and reliability of INBS's sweat-based drug testing method.
The PK study's clinical phase concluded in June 2024, with data under review. The method comparison study involved 135 subjects across three sites. These studies are designed to demonstrate that INBS's fingerprint sweat testing is comparable or superior to traditional methods like blood, saliva, and urine tests.
INBS expects to complete clinical data analysis and submit the 510(k) package in the fourth quarter of 2024. FDA clearance would allow INBS to market its product as a clinically validated tool, potentially transforming drug screening in various sectors.
Intelligent Bio Solutions Inc. (Nasdaq: INBS) ha completato con successo i test in clinica per il suo piano di studio clinico, un passo importante verso la presentazione della 510(k) all'FDA. Gli studi, che includono uno studio farmacocinetico (PK) e uno studio di confronto dei metodi e di usabilità, mirano a convalidare l'accuratezza e l'affidabilità del metodo di test dei farmaci basato sul sudore di INBS.
La fase clinica dello studio PK si è conclusa a giugno 2024, con i dati attualmente in fase di revisione. Lo studio di confronto dei metodi ha coinvolto 135 soggetti in tre sedi. Questi studi sono progettati per dimostrare che il test del sudore tramite impronte digitali di INBS è comparabile o superiore ai metodi tradizionali come test del sangue, saliva e urine.
INBS prevede di completare l'analisi dei dati clinici e di presentare il pacchetto 510(k) nel quarto trimestre del 2024. L'approvazione dell'FDA consentirebbe a INBS di commercializzare il suo prodotto come uno strumento validato clinicamente, potenzialmente trasformando lo screening dei farmaci in vari settori.
Intelligent Bio Solutions Inc. (Nasdaq: INBS) ha completado con éxito las pruebas clínicas para su plan de estudio clínico, un paso importante hacia la presentación de la 510(k) a la FDA. Los estudios, que incluyen un estudio farmacocinético (PK) y un estudio de comparación de métodos y usabilidad, tienen como objetivo validar la precisión y fiabilidad del método de prueba de drogas basado en sudor de INBS.
La fase clínica del estudio PK concluyó en junio de 2024, con datos que están en revisión. El estudio de comparación de métodos involucró a 135 sujetos en tres sitios. Estos estudios están diseñados para demostrar que la prueba de sudor a través de huellas dactilares de INBS es comparable o superior a los métodos tradicionales como las pruebas de sangre, saliva y orina.
INBS espera completar el análisis de datos clínicos y presentar el paquete 510(k) en el cuarto trimestre de 2024. La aprobación de la FDA permitiría a INBS comercializar su producto como una herramienta clínicamente validada, transformando potencialmente el screening de drogas en varios sectores.
Intelligent Bio Solutions Inc. (Nasdaq: INBS)는 임상 시험을 성공적으로 완료했습니다. 이는 FDA 510(k) 제출을 위한 중요한 단계입니다. 이 연구에는 약리학적 연구(PK 연구)와 방법 비교 및 사용성 연구가 포함되어 있으며, INBS의 땀 기반 약물 검사 방법의 정확성과 신뢰성을 검증하는 것을 목표로 하고 있습니다.
PK 연구의 임상 단계는 2024년 6월에 종료되었으며, 현재 데이터가 검토 중입니다. 방법 비교 연구는 세 곳에서 135명의 피험자가 참여했습니다. 이 연구들은 INBS의 지문 땀 검사가 혈액, 침 및 소변 검사와 같은 전통적인 방법과 비교 가능하거나 우수하다는 것을 증명하기 위해 설계되었습니다.
INBS는 임상 데이터 분석을 완료하고 2024년 4분기에 510(k) 패키지를 제출할 것으로 예상하고 있습니다. FDA 승인은 INBS가 제품을 임상적으로 검증된 도구로 시장에 출시할 수 있게 하여 다양한 분야의 약물 스크리닝을 혁신할 수 있습니다.
Intelligent Bio Solutions Inc. (Nasdaq: INBS) a réussi à compléter les tests cliniques pour son plan d'étude clinique, une étape importante vers la soumission de 510(k) à la FDA. Les études, incluant une étude pharmacocinétique (PK) et une étude de comparaison des méthodes et d'utilisabilité, visent à valider l'exactitude et la fiabilité de la méthode de test de drogue basée sur la sueur d'INBS.
La phase clinique de l'étude PK s'est conclue en juin 2024, avec des données actuellement en révision. L'étude de comparaison des méthodes a impliqué 135 sujets répartis sur trois sites. Ces études sont conçues pour démontrer que le test de sueur par empreinte digitale d'INBS est comparable ou supérieur aux méthodes traditionnelles telles que les tests sanguins, salivaires et urinaires.
INBS s'attend à terminer l'analyse des données cliniques et à soumettre le paquet 510(k) au quatrième trimestre de 2024. L'approbation de la FDA permettrait à INBS de commercialiser son produit comme un outil cliniquement validé, transformant potentiellement le dépistage de drogues dans divers secteurs.
Intelligent Bio Solutions Inc. (Nasdaq: INBS) hat die klinischen Tests erfolgreich abgeschlossen, was einen wichtigen Schritt in Richtung FDA 510(k) Einreichung darstellt. Die Studien, darunter eine pharmakokinetische (PK) Studie und eine Methodenvergleichs- und Gebrauchstauglichkeitsstudie, zielen darauf ab, die Genauigkeit und Zuverlässigkeit der schweißbasierten Drogenprüfmethode von INBS zu validieren.
Die klinische Phase der PK-Studie wurde im Juni 2024 abgeschlossen, und die Daten werden derzeit überprüft. Die Methodenvergleichsstudie umfasste 135 Probanden an drei Standorten. Diese Studien sind darauf ausgelegt, zu zeigen, dass INBS' Fingerabdruck-Schweißuntersuchung mit herkömmlichen Methoden wie Blut-, Speichel- und Urinuntersuchungen vergleichbar oder überlegen ist.
INBS erwartet, die klinische Datenanalyse abzuschließen und das 510(k)-Paket im vierten Quartal 2024 einzureichen. Die FDA-Zulassung würde es INBS ermöglichen, sein Produkt als klinisch validiertes Werkzeug auf dem Markt anzubieten, was das Drogen-Screening in verschiedenen Sektoren potenziell transformieren könnte.
- Successful completion of in-clinic testing for FDA 510(k) submission
- Pharmacokinetic (PK) study and method comparison study completed
- 135 subjects participated in the method comparison and usability study
- Clinical data analysis and 510(k) package submission expected in Q4 2024
- None.
Insights
The completion of in-clinic testing for Intelligent Bio Solutions' (INBS) clinical study plan marks a significant milestone in their journey towards FDA 510(k) submission. This development is important for several reasons:
- The pharmacokinetic (PK) study aims to demonstrate the superiority or comparability of fingerprint sweat testing to traditional matrices like blood, saliva and urine.
- The method comparison and usability study, involving 135 subjects across three sites, will validate the accuracy of their fingerprint sweat drug screening method.
- Successful completion of these studies brings INBS closer to obtaining FDA 510(k) Notification clearance, a critical step for market entry.
The potential impact on the drug testing industry is substantial. If approved, this non-invasive, sweat-based method could disrupt traditional drug testing approaches, offering a more convenient and potentially more accurate alternative. For investors, this progress signals that INBS is advancing towards commercialization, which could significantly impact the company's
NEW YORK, Sept. 27, 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 the successful completion of in-clinic testing proposed to the FDA earlier this year in the Company’s clinical study plan. The clinical studies are a key element of the Company's 510(k) submission, designed to demonstrate the accuracy and reliability of its sweat-based testing method.
The studies included a pharmacokinetic (PK) study, which aimed to demonstrate that the measurement of drugs in fingerprint sweat delivers results comparable or superior to other specimen matrices, such as blood, saliva and urine. In addition to the PK study, a method comparison and usability study was conducted to validate the accuracy of the Company's fingerprint sweat drug screening method in the hands of intended users.
The clinical phase of the PK study concluded in June 2024, with all laboratory analyses completed and data currently under review. The method comparison and usability studies, carried out across three sites, involved 135 subjects who were randomly dosed with codeine and then tested using the Company's drug screening system. The accuracy of the screening system results will be assessed relative to a traceable, laboratory-based reference method. “Executing these clinical studies required diligence and collaboration across multiple functions within Intelligent Bio Solutions and our CRO partners, CenExel and Cliantha,” said Daniel Brown, Head of Clinical Affairs at INBS.
“Completion of these in-clinic studies marks a significant achievement for our team and brings us closer to our goal of obtaining FDA 510(k) Notification clearance,” said Harry Simeonidis, President and CEO at INBS. “The early feedback on results from these studies demonstrates the potential of our fingerprint-based testing method to provide a non-invasive, reliable alternative to traditional drug testing methods and address the needs of diverse sectors, including workplaces and government agencies.”
With the in-clinic testing phase now complete, INBS is preparing for the next steps in its FDA submission process. Achieving FDA clearance will enable the Company to market its product as a clinically validated tool, paving the way for adoption in the US and potentially transforming the landscape of drug screening. The Company expects clinical data analysis to be completed in the fourth calendar quarter of 2024 and to submit the 510(k) package during the same quarter.
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 the 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. The Company’s current customer segments outside the US 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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