Intelligent Bio Solutions Announces Positive Results of PK Study, a Key Milestone on Path to FDA 510(k) Submission
Intelligent Bio Solutions (INBS) announced positive results from its Pharmacokinetic (PK) study, a important step towards FDA 510(k) submission. The study demonstrated that fingerprint sweat effectively mirrors codeine levels in blood and saliva, validating it as a reliable sample matrix for drug detection. The study involved 39 diverse subjects and utilized LC-MS/MS analysis. Statistical comparisons at 95% confidence level showed quantitative PK data closely aligned with blood samples. Upon FDA 510(k) clearance, INBS plans to launch its non-invasive drug screening technology in the US market in 2025, targeting safety-critical industries, law enforcement, and rehabilitation sectors.
Intelligent Bio Solutions (INBS) ha annunciato risultati positivi dal suo studio di farmacocinetica (PK), un passo importante verso la presentazione della domanda FDA 510(k). Lo studio ha dimostrato che il sudore digitale riflette in modo efficace i livelli di codeina nel sangue e nella saliva, validandolo come un matrice campionaria affidabile per la rilevazione di droghe. Lo studio ha coinvolto 39 soggetti diversi e ha utilizzato l'analisi LC-MS/MS. I confronti statistici a un livello di confidenza del 95% hanno mostrato dati PK quantitativi strettamente allineati con i campioni di sangue. Dopo il nulla osta FDA 510(k), INBS prevede di lanciare la sua tecnologia di screening non invasivo per droghe nel mercato statunitense nel 2025, mirando a settori critici per la sicurezza, all'applicazione della legge e ai settori della riabilitazione.
Intelligent Bio Solutions (INBS) anunció resultados positivos de su estudio de farmacocinética (PK), un paso importante hacia la presentación de la solicitud FDA 510(k). El estudio demostró que el sudor digital refleja de manera efectiva los niveles de codeína en sangre y saliva, validándolo como una matriz de muestra confiable para la detección de drogas. El estudio involucró a 39 sujetos diversos y utilizó análisis LC-MS/MS. Las comparaciones estadísticas a un nivel de confianza del 95% mostraron que los datos PK cuantitativos estaban estrechamente alineados con las muestras de sangre. Tras la autorización FDA 510(k), INBS planea lanzar su tecnología de detección no invasiva de drogas en el mercado estadounidense en 2025, enfocándose en industrias críticas para la seguridad, la aplicación de la ley y los sectores de rehabilitación.
인텔리전트 바이오 솔루션즈 (INBS)는 약리학적 연구(PK)에서 긍정적인 결과를 발표하며 FDA 510(k) 제출을 향한 중요한 단계를 밟았습니다. 연구는 지문땀이 혈액 및 타액 내의 코데인 수치를 효과적으로 반영함을 입증하여 약물 탐지를 위한 신뢰할 수 있는 샘플 매트릭스로 검증되었습니다. 이 연구는 39명의 다양한 피험자를 포함했으며 LC-MS/MS 분석을 활용하였습니다. 95% 신뢰 수준에서의 통계 비교는 정량적 PK 데이터가 혈액 샘플과 밀접하게 일치함을 보여주었습니다. FDA 510(k) 승인 후 INBS는 2025년 미국 시장에 비침습적 약물 검사 기술을 출시할 계획이며, 안전이 중요한 산업, 법 집행 및 재활 분야를 목표로 하고 있습니다.
Intelligent Bio Solutions (INBS) a annoncé des résultats positifs de son étude pharmacocinétique (PK), une étape importante vers la soumission FDA 510(k). L'étude a démontré que la sueur de doigts reflète efficacement les niveaux de codéine dans le sang et la salive, la validant en tant que matrice d'échantillon fiable pour la détection de drogues. L'étude a impliqué 39 sujets divers et a utilisé l'analyse LC-MS/MS. Les comparaisons statistiques à un niveau de confiance de 95 % ont montré que les données PK quantitatives étaient étroitement alignées avec les échantillons de sang. Suite à la libération FDA 510(k), INBS prévoit de lancer sa technologie de dépistage de drogue non invasive sur le marché américain en 2025, ciblant les industries critiques pour la sécurité, l'application de la loi et les secteurs de réhabilitation.
Intelligent Bio Solutions (INBS) hat positive Ergebnisse aus seiner pharmakokinetischen (PK) Studie angekündigt, ein wichtiger Schritt in Richtung FDA 510(k) Einreichung. Die Studie hat gezeigt, dass Fingerabdruckschweiß effektiv die Codeinwerte im Blut und Speichel widerspiegelt, wodurch er als zuverlässige Probenmatrix für die Drogenanalyse validiert wird. Die Studie umfasste 39 verschiedene Probanden und verwendete die LC-MS/MS-Analyse. Statistische Vergleiche auf einem Vertrauensniveau von 95% zeigten, dass die quantitativen PK-Daten eng mit den Blutproben übereinstimmten. Nach der FDA 510(k) Genehmigung plant INBS, seine nicht-invasive Drogen-Testtechnologie im Jahr 2025 auf dem US-Markt einzuführen, mit dem Ziel, sich auf sicherheitskritische Branchen, Strafverfolgung und Rehabilitationssektoren zu konzentrieren.
- PK study successfully validated fingerprint sweat as reliable drug detection method
- Study results show strong correlation between fingerprint sweat and blood samples at 95% confidence level
- Potential market entry in 2025 pending FDA 510(k) clearance
- Study exceeded minimum requirement with 39 subjects vs. required 36
- FDA 510(k) clearance still pending
- Market entry delayed until 2025
Insights
The successful PK study results represent a significant milestone for INBS' drug screening technology. The data demonstrates that fingerprint sweat correlates strongly with blood and saliva samples for drug detection, validated at a
The study's robust design, including 39 diverse subjects (exceeding the minimum requirement of 36) and the use of gold-standard LC-MS/MS analysis methodology strengthens the validity of these findings. The technology's potential FDA 510(k) clearance pathway appears promising, with submission planned for Q4 2023 and possible market entry in 2025.
The fingerprint-based testing platform could capture significant market share in safety-critical industries, offering advantages over traditional invasive testing methods. However, successful commercialization will depend on pricing strategy, adoption rates and competition from established testing methods.
For a micro-cap company with a market cap of just
The planned 2025 market entry timing aligns with increasing workplace drug testing demands and stricter safety regulations. However, investors should note that successful FDA clearance and market penetration will require significant resources for commercialization, suggesting potential future capital needs. The company's ability to scale production and establish distribution channels will be important for market success.
PK Study Successfully Demonstrates that Fingerprint Sweat Provides Reliable Sample for Drug Detection
FDA 510(k) Clearance Would Enable the Introduction of INBS’ Technology to the US in 2025
NEW YORK, Nov. 13, 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 strong initial results from its Pharmacokinetic (PK) study required for an FDA 510(k) submission. The data from the PK study shows that fingerprint sweat mimics the rate and extent of codeine in blood and saliva. The study successfully demonstrated that fingerprint sweat provides a reliable sample matrix for drug detection, showing quantitative PK data closely aligned to blood, based on statistical comparisons made at the
"The close correlation of PK parameters in fingerprint sweat and blood highlights its robustness as a sampling approach. While independent data has consistently supported this, our clinical study further reinforces these findings,” said Harry Simeonidis, President and CEO of Intelligent Bio Solutions. “We are very pleased with the PK study results. This data highlights the potential for our technology to achieve widespread adoption in safety-critical industries and beyond, marking a significant achievement as we advance toward FDA clearance in the United States."
FDA 510(k) clearance would enable INBS to introduce its innovative drug screening technology to the US market in 2025. The PK study results and other clinical data from the Company's clinical study plan will be submitted as part of the Company's 510(k) submission, expected in the fourth calendar quarter of this year. INBS is well-positioned to meet the increasing demand for drug testing in the United States, particularly in safety-critical industries like construction, mining, and transportation, as well as in law enforcement, drug rehabilitation, and forensic sectors.
Results: Average Codeine Values in Whole Blood, Oral Fluid and Fingerprint Sweat1
The study results show that fingerprint sweat is a strong indicator of codeine ingestion. They further validate the ability of INBS' method to provide rapid and reliable drug screening through a simple fingerprint sweat sample without invasive procedures.
The PK study, conducted in partnership with Cliantha Research, required a minimum of 36 subjects. The Company successfully recruited 39 healthy adult subjects from diverse backgrounds, including varying genders, ages, and ethnicities. The study compared the levels of opiates detected in fingerprint sweat with those found in blood, oral fluid, and urine samples following the medically supervised administration of codeine. All fingerprint sweat specimens collected using INBS' Intelligent Fingerprinting Drug Screening System, were analyzed by a validated, traceable liquid chromatography/tandem mass spectrometry (LC-MS/MS) method, widely accepted as the gold standard for such studies.
About Intelligent Bio Solutions
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:
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INBS@kcsa.com
1 Urine results are not included in this chart. Due to the nature of urine sample collection, which depends on an individual's need to urinate, samples cannot be collected at fixed intervals. Therefore, urine specimens were collected on an ad-lib basis as frequently as possible.
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/6806ebb4-b738-4c65-b0a0-e6a4c1dc9626
FAQ
What were the results of INBS's Pharmacokinetic study for drug detection?
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