Caris Life Sciences Demonstrates Scientific Rigor with Clinical Validation of FDA-Approved MI Cancer Seek庐
Caris Life Sciences (NASDAQ: CAI) has published a validation study in Oncotarget for its FDA-approved MI Cancer Seek庐 companion diagnostic assay. The test is the first and only FDA-approved solution combining whole exome and whole transcriptome sequencing for solid tumor profiling in both adult and pediatric patients.
MI Cancer Seek demonstrates exceptional performance with 97-100% positive and negative agreement compared to other FDA-approved assays. The test analyzes 228 genes for various mutations, microsatellite instability, tumor mutational burden, and copy number amplification in breast cancer patients. Notably, it enables simultaneous RNA and DNA extraction from minimal tissue input, streamlining the testing process and potentially reducing delays in treatment decisions.
Caris Life Sciences (NASDAQ: CAI) ha pubblicato su Oncotarget uno studio di validazione per il suo saggio diagnostico companion approvato dalla FDA, MI Cancer Seek庐. Il test 猫 la prima e unica soluzione approvata dalla FDA che combina il sequenziamento dell'esoma completo e del trascrittoma completo per il profilo dei tumori solidi in pazienti adulti e pediatrici.
MI Cancer Seek mostra prestazioni eccellenti con un accordo positivo e negativo del 97-100% rispetto ad altri test approvati dalla FDA. L'analisi copre 228 geni per rilevare varie mutazioni, l'instabilit脿 dei microsatelliti, il burden mutazionale tumorale e le amplificazioni del numero di copie nel carcinoma mammario. In particolare, consente l'estrazione simultanea di RNA e DNA da quantit脿 minime di tessuto, semplificando il processo e potenzialmente riducendo i ritardi nelle decisioni terapeutiche.
Caris Life Sciences (NASDAQ: CAI) ha publicado en Oncotarget un estudio de validaci贸n de su ensayo diagn贸stico complementario aprobado por la FDA, MI Cancer Seek庐. La prueba es la primera y 煤nica soluci贸n aprobada por la FDA que combina secuenciaci贸n del exoma completo y del transcriptoma completo para el perfilado de tumores s贸lidos en pacientes adultos y pedi谩tricos.
MI Cancer Seek demuestra un rendimiento excepcional con una concordancia positiva y negativa del 97-100% frente a otros ensayos aprobados por la FDA. El test analiza 228 genes para detectar diversas mutaciones, inestabilidad de microsat茅lites, carga mutacional tumoral y amplificaci贸n del n煤mero de copias en pacientes con c谩ncer de mama. Cabe destacar que permite la extracci贸n simult谩nea de ARN y ADN a partir de una m铆nima cantidad de tejido, agilizando el proceso y potencialmente reduciendo demoras en las decisiones de tratamiento.
Caris Life Sciences (NASDAQ: CAI)電� 鞛愳偓鞚� FDA 鞀轨澑 霃欕皹歆勲嫧 瓴�靷� MI Cancer Seek庐鞐� 雽�頃� 瓴�歃� 鞐瓣惮毳� Oncotarget鞐� 氚滍憸頄堨姷雼堧嫟. 鞚� 瓴�靷姅 靹膘澑 氚� 靻岇晞 頇橃瀽鞚� 瓿犿槙 膦呾枒 頂勲韺岇澕毵侅潉 鞙勴暣 鞝勳泊 鞐戩啘 鞁滍��鞁标臣 鞝勳泊 鞝勳偓觳� 鞁滍��鞁膘潉 瓴绊暕頃� FDA 鞀轨澑 斓滌磮鞚挫瀽 鞙犾澕頃� 靻旊（靺�鞛呺媹雼�.
MI Cancer Seek電� 雼るジ FDA 鞀轨澑 瓴�靷檧 牍勱祼頃� 97-100%鞚� 鞏戩劚 氚� 鞚岇劚 鞚检箻鞙�搿� 鞖办垬頃� 靹彪姤鞚� 氤挫榾鞀惦媹雼�. 鞚� 瓴�靷姅 鞙犽癌鞎� 頇橃瀽鞐愳劀 雼れ枒頃� 霃岇棸氤�鞚�, 毵堨澊韥靸堩媭霛检澊韸� 攵堨晥鞝曥劚, 膦呾枒 氤�鞚� 攵�雼�(TMB), 氚� 氤奠牅靾� 歃濏彮鞚� 鞙勴暣 228臧� 鞙犾爠鞛�毳� 攵勳劃頃╇媹雼�. 韸鬼瀳 斓滌唽頃滌潣 臁办鞙茧 RNA鞕� DNA毳� 霃欖嫓鞐� 於旍稖頃� 靾� 鞛堨柎 瓴�靷� 瓿检爼鞚� 臧勳唽頇旐晿瓿� 旃橂 瓴办爼 歆�鞐办潉 欷勳澕 靾� 鞛堨姷雼堧嫟.
Caris Life Sciences (NASDAQ: CAI) a publi茅 dans Oncotarget une 茅tude de validation pour son test diagnostique compagnon approuv茅 par la FDA, MI Cancer Seek庐. Ce test est la premi猫re et unique solution approuv茅e par la FDA combinant le s茅quen莽age de l'exome complet et du transcriptome complet pour le profilage des tumeurs solides chez les patients adultes et p茅diatriques.
MI Cancer Seek affiche des performances remarquables avec une concordance positive et n茅gative de 97 脿 100 % par rapport 脿 d'autres tests approuv茅s par la FDA. Le test analyse 228 g猫nes pour d茅tecter diverses mutations, l'instabilit茅 des microsatellites, la charge mutationnelle tumorale et les amplifications du nombre de copies chez les patientes atteintes de cancer du sein. Il permet notamment l'extraction simultan茅e d'ARN et d'ADN 脿 partir d'un apport tissulaire minime, simplifiant le processus et r茅duisant potentiellement les d茅lais de d茅cision th茅rapeutique.
Caris Life Sciences (NASDAQ: CAI) hat in Oncotarget eine Validierungsstudie f眉r seinen von der FDA zugelassenen Companion-Diagnostiktest MI Cancer Seek庐 ver枚ffentlicht. Der Test ist die erste und einzige von der FDA zugelassene L枚sung, die Whole-Exome- und Whole-Transcriptome-Sequenzierung zur Profilierung solider Tumoren bei Erwachsenen und Kindern kombiniert.
MI Cancer Seek zeigt eine herausragende Leistung mit einer positiven und negativen 脺bereinstimmung von 97鈥�100% im Vergleich zu anderen FDA-zugelassenen Tests. Der Test analysiert 228 Gene auf verschiedene Mutationen, Mikrosatelliteninstabilit盲t, Tumormutationslast und Kopienzahlamplifikationen bei Brustkrebspatientinnen. Bemerkenswert ist, dass er die gleichzeitige Extraktion von RNA und DNA aus minimalem Gewebe erm枚glicht, den Testablauf vereinfacht und potenziell Verz枚gerungen bei Therapieentscheidungen reduziert.
- First FDA-approved test combining whole exome and whole transcriptome sequencing for solid tumor profiling
- Exceptional clinical performance with 97-100% agreement compared to other FDA-approved assays
- Enables simultaneous RNA and DNA extraction from minimal tissue samples, improving efficiency
- Supports eight companion diagnostic claims for targeted therapies
- None.
Insights
Caris validates MI Cancer Seek庐 CDx test with exceptional accuracy (97-100%), strengthening its position in precision oncology market.
Caris Life Sciences' publication in Oncotarget represents a significant advancement in precision oncology. Their MI Cancer Seek庐 test has achieved 97-100% positive and negative percent agreement compared to other FDA-approved assays, establishing its reliability for clinical use. This is the first and only FDA-approved companion diagnostic combining whole exome and whole transcriptome sequencing for solid tumors in both adult and pediatric patients.
The key technical differentiation is MI Cancer Seek's ability to perform simultaneous RNA and DNA extraction from minimal tissue input. This creates a substantial competitive advantage over conventional assays that require separate testing processes for DNA and RNA, which typically demand more tissue and introduce potential delays in treatment decisions.
The test's comprehensive capabilities are impressive - detecting single nucleotide variants and insertions/deletions across 228 genes, plus microsatellite instability, tumor mutational burden, and copy number amplification in breast cancer patients. With eight companion diagnostic claims targeting high clinical burden areas, this positions Caris strongly in the precision medicine market.
For oncologists, this validation provides confidence in using a single comprehensive test rather than ordering multiple separate assays, potentially reducing diagnostic time and preserving precious tumor samples. This aligns with the growing clinical need for tissue conservation while maximizing molecular information to guide targeted therapy selection - a critical balance in modern oncology practice.
The study demonstrates that MI Cancer Seek works reliably for detecting multiple variant types of high clinical significance, and that its approved medical uses follow strict laboratory standards. The assay supports eight companion diagnostic (CDx) claims, each addressing high clinical burden areas and demonstrating strong performance when compared to other FDA-approved assays, with positive and negative percent agreement ranging from
"MI Cancer Seek provides a comprehensive molecular blueprint that saves tissue without compromising results. The study results underscore our commitment to ongoing scientific integrity and validation," said ,听President of Caris. "Patients and physicians deserve this level of diligence and scientific rigor when selecting a molecular profiling assay to inform cancer treatment."
"Broad-based biomarker panels are key to improving outcomes in precision medicine, yet many patients still miss out on comprehensive molecular profiling,"听said , Caris EVP and Chief Medical Officer.听"By integrating companion diagnostic tests into multi-gene panels that make the most of tissue samples, we can reduce inefficiencies and potentially help more patients access personalized therapies."
MI Cancer Seek is a next-generation sequencing (NGS) based in vitro diagnostic (IVD) device using total nucleic acid (TNA) isolated from formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens for the detection of single nucleotide variants (SNVs) and insertions and deletions (indels) in 228 genes, microsatellite instability (MSI), tumor mutational burden (TMB) in patients with previously diagnosed solid tumors, and copy number amplification (CNA) in one gene in patients with breast cancer. MI Cancer Seek is intended as a companion diagnostic to identify patients who may benefit from treatment with the targeted therapies, in accordance with the approved therapeutic product labeling. Additionally, MI Cancer Seek is intended to provide tumor mutational profiling to be used by qualified healthcare professionals in accordance with professional oncology guidelines for cancer patients with previously diagnosed solid malignant neoplasms.
The publication can be viewed in its entirety on the .
About Caris Life Sciences听
Caris Life Sciences庐鈥�(Caris) is a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer that is actively developing and commercializing innovative solutions to transform healthcare. Through comprehensive molecular profiling (Whole Exome and Whole Transcriptome Sequencing) and the application of advanced AI and machine learning algorithms at scale, Caris has created the large-scale, multimodal clinico-genomic database and computing capability needed to analyze and further unravel the molecular complexity of disease. This convergence of next-generation sequencing, AI and machine learning technologies, and high-performance computing provides a differentiated platform to develop the latest generation of advanced precision medicine diagnostic solutions for early detection, diagnosis, monitoring, therapy selection and drug development.听
Caris was founded with the belief and vision that combining a vast set of consistently generated molecular information with robust data-driven insights could realize the potential of precision medicine for patients. Headquartered in
Forward Looking Statements
This press release contains forward-looking statements, within the meaning of the federal securities laws, about Caris Life Sciences and its business. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases forward-looking statements can be identified by words such as "may," "will," "should," "would," "expect," "plan," "anticipate," "could," "intend," "target," "project," "potential," "contemplate," "believe," "estimate," "predict," "potential," "supports" or "continue" or similar expressions.听听听
You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in these forward-looking statements are reasonable based on information currently available to us, we cannot guarantee that the future results, discoveries, levels of activity, performance or events and circumstances reflected in forward-looking statements will be achieved or occur. Forward-looking statements involve known and unknown risks and uncertainties, some of which are beyond our control. Risks and uncertainties that could cause our actual results to differ materially from those indicated or implied by the forward-looking statements in this press release include, among other things: developments in the precision oncology industry; future financial performance, results of operations or other operational results or metrics; development, validation and timing of future solutions; the rapidly evolving competitive environment in which we operate; third-party payer reimbursement and coverage decisions; our ability to protect and enhance our intellectual property; regulatory requirements, decisions or approvals (including the timing and conditions thereof) related to our solutions; our compliance with laws and regulations; and our ability to hire and retain key personnel as well as risks, uncertainties, and other factors described in the section titled "Risk Factors" and elsewhere in the prospectus for our initial public offering filed with the Securities and Exchange Commission on June 20, 2025, and in our other filings we make with the SEC from time to time. We undertake no obligation to update any forward-looking statements to reflect changes in events, circumstances or our beliefs after the date of this press release, except as required by law.听
Caris Life Sciences Media:
Corporate Communications
[email protected]
214.294.5606
View original content to download multimedia:
SOURCE Caris Life Sciences
FAQ
What is Caris Life Sciences' MI Cancer Seek and what makes it unique?
How accurate is MI Cancer Seek compared to other FDA-approved assays?
What types of mutations can MI Cancer Seek detect?
How does MI Cancer Seek benefit cancer patients and physicians?
What is the intended use of Caris Life Sciences' MI Cancer Seek?
