T2 Biosystems Receives FDA Clearance to Market the T2Candida Panel for Pediatric Patients
T2 Biosystems (NASDAQ:TTOO) has received FDA clearance to market its T2Candida® Panel for pediatric patients, expanding its market to over 200 children's hospitals in the U.S. The T2Candida Panel is the only FDA-cleared diagnostic test that can detect sepsis-causing Candida species directly from blood in 3-5 hours, without waiting for blood culture results. It detects five Candida species that account for up to 95% of all Candida bloodstream infections in the U.S.
Studies show that the T2Candida Panel detects Candida species significantly faster and with greater sensitivity than blood culture-based diagnostics. A study at Bambino Gesù hospital found that the panel provided results 121.8 hours faster than blood culture and detected additional infections missed by traditional methods. This clearance allows T2 Biosystems to improve outcomes and reduce costs for pediatric patients through faster targeted antifungal treatment.
T2 Biosystems (NASDAQ:TTOO) ha ricevuto l'autorizzazione dalla FDA per commercializzare il suo T2Candida® Panel per pazienti pediatrici, ampliando il suo mercato a oltre 200 ospedali pediatrici negli Stati Uniti. Il T2Candida Panel è il primo test diagnostico approvato dalla FDA che può rilevare le specie di Candida responsabili della sepsi direttamente dal sangue in 3-5 ore, senza dover attendere i risultati delle colture ematiche. Rileva cinque specie di Candida che rappresentano fino al 95% di tutte le infezioni da Candida nel sangue negli Stati Uniti.
Gli studi dimostrano che il T2Candida Panel rileva le specie di Candida in modo significativamente più rapido e con maggiore sensibilità rispetto ai test diagnostici basati sulle colture ematiche. Uno studio presso l'ospedale Bambino Gesù ha trovato che il panel forniva risultati 121.8 ore più rapidamente rispetto alle colture ematiche e rilevava infezioni aggiuntive trascurate dai metodi tradizionali. Questa autorizzazione consente a T2 Biosystems di migliorare gli esiti e ridurre i costi per i pazienti pediatrici attraverso un trattamento antifungino mirato più rapido.
T2 Biosystems (NASDAQ:TTOO) ha recibido la aprobación de la FDA para comercializar su Panel T2Candida® para pacientes pediátricos, ampliando su mercado a más de 200 hospitales infantiles en los Estados Unidos. El Panel T2Candida es la única prueba diagnóstica aprobada por la FDA que puede detectar especies de Candida causantes de sepsis directamente de la sangre en 3-5 horas, sin esperar los resultados de los cultivos de sangre. Detecta cinco especies de Candida que representan hasta el 95% de todas las infecciones por Candida en el torrente sanguíneo en los EE. UU.
Los estudios muestran que el Panel T2Candida detecta especies de Candida significativamente más rápido y con mayor sensibilidad que los diagnósticos basados en cultivos de sangre. Un estudio en el hospital Bambino Gesù encontró que el panel proporcionaba resultados 121.8 horas más rápido que el cultivo de sangre y detectaba infecciones adicionales que los métodos tradicionales pasaban por alto. Esta aprobación permite a T2 Biosystems mejorar los resultados y reducir los costos para los pacientes pediátricos a través de un tratamiento antifúngico dirigido más rápido.
T2 바이오시스템스(NASDAQ:TTOO)는 FDA 승인을 받았습니다 T2Candida® 패널을 소아 환자에게 판매하기 위해, 미국의 200개 이상의 어린이 병원으로 시장을 확대하고 있습니다. T2Candida 패널은 FDA에서 승인된 유일한 진단 검사로, 혈액 문화 결과를 기다리지 않고도 3-5시간 내에 혈액에서 패혈증을 유발하는 Candida 종을 직접 감지할 수 있습니다. 미국 내 모든 Candida 혈류 감염의 95%를 차지하는 5종의 Candida 종을 감지합니다.
연구에 따르면 T2Candida 패널은 혈액 배양 검사를 기반으로 한 진단보다 상당히 더 빠르고 높은 민감도로 Candida 종을 발견합니다. 방비노 제수 병원에서 실시된 연구에서는 이 패널이 혈액 배양보다 121.8시간 더 빠른 결과를 제공하며 전통적인 방법으로 간과된 추가 감염을 감지했습니다. 이 승인은 T2 바이오시스템스에게 소아 환자들에게 더욱 빠른 표적 항진균 치료를 통해 결과를 개선하고 비용을 절감할 수 있게 합니다.
T2 Biosystems (NASDAQ:TTOO) a reçu l'autorisation de la FDA pour commercialiser son T2Candida® Panel pour les patients pédiatriques, élargissant ainsi son marché à plus de 200 hôpitaux pour enfants aux États-Unis. Le T2Candida Panel est le seul test diagnostique approuvé par la FDA capable de détecter les espèces de Candida responsables de la sepsie directement à partir du sang en 3-5 heures, sans attendre les résultats des cultures sanguines. Il détecte cinq espèces de Candida qui représentent jusqu'à 95 % de toutes les infections sanguines par Candida aux États-Unis.
Des études montrent que le T2Candida Panel détecte les espèces de Candida de manière significativement plus rapide et avec une sensibilité supérieure par rapport aux diagnostics basés sur des cultures sanguines. Une étude menée à l'hôpital Bambino Gesù a révélé que le panel fournissait des résultats 121,8 heures plus rapidement que les cultures sanguines et détectait des infections supplémentaires manquées par les méthodes traditionnelles. Cette autorisation permet à T2 Biosystems d'améliorer les résultats et de réduire les coûts pour les patients pédiatriques grâce à un traitement antifongique ciblé plus rapide.
T2 Biosystems (NASDAQ:TTOO) hat die Zulassung der FDA erhalten, um ihr T2Candida® Panel für pediatrische Patienten zu vermarkten, was den Markt auf über 200 Kinderkrankenhäuser in den USA ausweitet. Das T2Candida Panel ist der einzige von der FDA zugelassene diagnostische Test, der Sepsis-verursachende Candida-Arten direkt aus Blut innerhalb von 3-5 Stunden erkennen kann, ohne auf die Ergebnisse von Blutkulturen warten zu müssen. Es erkennt fünf Candida-Arten, die bis zu 95 % aller Candida-Blutstrominfektionen in den USA ausmachen.
Studien zeigen, dass das T2Candida Panel Candida-Arten deutlich schneller und mit größerer Sensitivität erkennt als diagnostische Tests, die auf Blutkulturen basieren. Eine Studie im Bambino Gesù Krankenhaus stellte fest, dass das Panel Ergebnisse 121,8 Stunden schneller lieferte als Blutkulturen und zusätzliche Infektionen entdeckte, die von herkömmlichen Methoden übersehen wurden. Diese Zulassung ermöglicht es T2 Biosystems, die Ergebnisse zu verbessern und die Kosten für pädiatrische Patienten durch schnellere gezielte antifungale Behandlung zu senken.
- FDA clearance for pediatric use of T2Candida Panel, expanding market to 200+ children's hospitals
- Only FDA-cleared test to detect Candida species directly from blood in 3-5 hours
- Detects 5 Candida species accounting for up to 95% of Candida bloodstream infections in the U.S.
- Significantly faster and more sensitive than blood culture-based diagnostics
- Study showed results 121.8 hours faster than blood culture
- Higher detection rate, identifying additional infections missed by blood culture
- Potential to improve patient outcomes and reduce healthcare costs
- None.
The FDA clearance for pediatric use of T2 Biosystems' T2Candida Panel is a significant advancement in rapid sepsis detection for children. This expansion allows for faster diagnosis and targeted treatment of Candida bloodstream infections, potentially reducing hospital stays and costs.
The panel's ability to detect five Candida species responsible for 95% of infections in just 3-5 hours, compared to days with traditional methods, is a game-changer. Studies showing 121.8 hours faster species identification and higher detection rates underscore its clinical value.
This clearance opens up a new market of over 200 children's hospitals in the U.S., potentially boosting T2 Biosystems' revenue. However, the company will need to effectively market and integrate the technology into pediatric care protocols to realize its full potential.
This FDA clearance is a positive catalyst for T2 Biosystems (NASDAQ:TTOO). It expands their addressable market to include over 200 children's hospitals in the U.S., potentially driving revenue growth. The
However, investors should note that market penetration and adoption rates will be crucial. The company's ability to convert this regulatory win into sales will be key. Watch for updates on pediatric market traction in upcoming quarterly reports. While this news is promising, T2 Biosystems' overall financial health and market position should be considered when evaluating its investment potential.
The T2Candida Panel's FDA clearance for pediatric use is a breakthrough in managing fungal sepsis in children. Its high sensitivity and specificity, as shown in the Clinical Infectious Diseases study, make it a valuable diagnostic tool. The panel's ability to detect infections missed by blood cultures could significantly improve patient outcomes.
Rapid detection in 3-5 hours allows for earlier targeted antifungal therapy, potentially reducing the 21-day average increased hospital stay. This speed is important in pediatric cases where timely intervention can be life-saving. However, clinicians will need to integrate this new tool into existing protocols and consider its cost-effectiveness in various clinical scenarios. Overall, this advancement has the potential to transform the management of invasive candidiasis in pediatric patients.
Expands available market to include over 200 children’s hospitals in the United States
LEXINGTON, Mass., Sept. 16, 2024 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO) (the “Company”), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its FDA-cleared T2Candida® Panel for pediatric patients. The Company expects to immediately begin marketing and selling the T2Candida Panel under the expanded pediatric claim.
The T2Candida Panel is the only FDA-cleared diagnostic test able to detect sepsis-causing Candida species directly-from-blood, in just 3-5 hours, without the need to wait days for a positive blood culture. The T2Candida Panel runs on the FDA-cleared T2Dx® Instrument and simultaneously detects five Candida species including, Candida albicans, Candida tropicalis, Candida parapsilosis, Candida krusei, and Candida glabrata. According to the U.S. Centers for Disease Control and Prevention (CDC), the five species detected by the T2Candida Panel account for up to
"This FDA clearance marks another important milestone in our commitment to expand the clinical utility of our sepsis test panels and allows our commercial team to immediately begin marketing and selling our test to over 200 children’s hospitals in the U.S.,” stated John Sperzel, Chairman and CEO of T2 Biosystems. “Studies show that the T2Candida Panel detects Candida species significantly faster, and with greater sensitivity, when compared to blood culture-based diagnostics, and we believe the new pediatric testing claim will allow clinicians to improve outcomes and reduce cost by achieving faster targeted antifungal treatment for their pediatric patients.”
According to the Journal of Fungi, a peer-reviewed scientific journal that provides an advanced forum for studies related to pathogenic fungi, Candida species are a major contributor to morbidity and mortality in hospitalized children. Moreover, children with invasive candidiasis present a significant burden to the U.S. healthcare system, with a mean increased hospital length of stay of 21 days and approximately
A Journal of Clinical Microbiology (2022) study conducted at the Bambino Gesù hospital in Rome, Italy found that pediatric patients suspected of fungal bloodstream infections that were tested with the T2Candida Panel received species identification results 121.8 hours faster compared to blood culture. The study also found a higher detection rate with the T2Candida Panel, as six additional probable or possible fungal bloodstream infections in pediatric patients were detected by the T2Candida Panel that were missed by blood culture. In addition, a prospective observational study published in Clinical Infectious Diseases (2022) evaluated the performance of four pre-blood culture tests for detecting the presence of invasive candidiasis in pediatric patients and found that the T2Candida Panel had the highest sensitivity and specificity of all four assays among five hundred patients enrolled. The T2Candida Panel was the only test recommended for individual use as a tool for the diagnosis of invasive candidiasis in at-risk children and adolescents.
About T2 Biosystems
T2 Biosystems, a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, is dedicated to improving patient care and reducing the cost of care by helping clinicians effectively treat patients faster than ever before. T2 Biosystems’ products are powered by the proprietary T2 Magnetic Resonance (T2MR®) technology and include the T2Dx® Instrument, the T2Bacteria® Panel, the T2Candida® Panel, the T2Resistance® Panel, and the T2Biothreat™ Panel. T2 Biosystems has an active pipeline of future products, including the U.S. T2Resistance Panel, the T2Lyme™ Panel, and the expended T2Candida Panel to add the detection of Candida auris. For more information, please visit www.t2biosystems.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the ability of the T2Candida Panel to detect Candida species in pediatric patients; the ability of the T2Candida Panel to detect Candida species in pediatric patients significantly faster and with greater sensitivity than blood culture; and the likelihood that the expansion of the T2Candida pediatric testing claim will allow clinicians to improve outcomes and reduce cost by achieving faster targeted antifungal treatment for their pediatric patients, as well as statements that include the words “expect,” “may,” “should,” “anticipate,” and similar statements of a future or forward-looking nature. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, (i) any inability to (a) realize anticipated benefits from commitments, contracts or products; (b) successfully execute strategic priorities; (c) bring products to market; (d) expand product usage or adoption; (e) obtain customer testimonials; (f) accurately predict growth assumptions; (g) realize anticipated revenues; (h) incur expected levels of operating expenses; or (i) increase the number of high-risk patients at customer facilities; (ii) failure of early data to predict eventual outcomes; (iii) failure to make or obtain anticipated FDA filings or clearances within expected time frames or at all; or (iv) the factors discussed under Item 1A. “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the U.S. Securities and Exchange Commission, or SEC, on April 1, 2024, and other filings the Company makes with the SEC from time to time, including our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, unless required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. Thus, no one should assume that the Company’s silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release.
Investor Contact:
Philip Trip Taylor, Gilmartin Group
ir@T2Biosystems.com
415-937-5406
FAQ
What is the significance of FDA clearance for T2 Biosystems' T2Candida Panel for pediatric use?
How does the T2Candida Panel compare to traditional blood culture methods for detecting Candida species?
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