GeneCentric Therapeutics Announces American Medical Association Has Granted a PLA Code for PurIST Pancreatic Cancer Test
GeneCentric Therapeutics has announced that the American Medical Association (AMA) has granted a Proprietary Laboratory Analysis (PLA) code for their PurIST pancreatic cancer test. This RNA expression-based test, licensed to Tempus AI (NASDAQ: TEM), is designed to inform and personalize treatment for pancreatic cancer patients.
The PurIST PLA code is the first Common Procedural Terminology (CPT) code created for algorithm-based analysis of previously sequenced RNA data from a laboratory developed test (LDT). This represents a significant step towards reimbursement for AI-enabled algorithms and supports the commercialization of PurIST.
The test classifies tumors of patients with unresectable stage III or stage IV pancreatic ductal adenocarcinoma (PDAC) as either basal or classical subtype, helping to guide first-line therapy in a cancer type with diagnostic options and high mortality rates.
GeneCentric Therapeutics ha annunciato che l'American Medical Association (AMA) ha concesso un codice Proprietary Laboratory Analysis (PLA) per il loro test per il cancro pancreatico PurIST. Questo test basato sull'espressione dell'RNA, concesso in licenza a Tempus AI (NASDAQ: TEM), è progettato per informare e personalizzare il trattamento per i pazienti affetti da cancro pancreatico.
Il codice PLA di PurIST è il primo codice Common Procedural Terminology (CPT) creato per l'analisi basata su algoritmi dei dati RNA sequenziati in precedenza da un test sviluppato in laboratorio (LDT). Questo rappresenta un passo significativo verso il rimborso per algoritmi abilitati all'AI e supporta la commercializzazione di PurIST.
Il test classifica i tumori dei pazienti con adenocarcinoma duttale pancreatico (PDAC) in stadio III o IV non resezionabile come di sottotipo basale o classico, aiutando a guidare la terapia di prima linea in un tipo di cancro con opzioni diagnostiche limitate e tassi di mortalità elevati.
GeneCentric Therapeutics ha anunciado que la American Medical Association (AMA) ha otorgado un código de Análisis de Laboratorio Proprietario (PLA) para su prueba de cáncer pancreático PurIST. Esta prueba basada en la expresión de RNA, licenciada a Tempus AI (NASDAQ: TEM), está diseñada para informar y personalizar el tratamiento de los pacientes con cáncer pancreático.
El código PLA de PurIST es el primer código de Terminología de Procedimiento Común (CPT) creado para el análisis basado en algoritmos de datos de RNA secuenciados previamente a partir de una prueba desarrollada en laboratorio (LDT). Esto representa un paso significativo hacia el reembolso para algoritmos habilitados por AI y apoya la comercialización de PurIST.
La prueba clasifica los tumores de pacientes con adenocarcinoma ductal pancreático (PDAC) en etapas III o IV no resecables como subtipo basal o clásico, ayudando a guiar la terapia de primera línea en un tipo de cáncer con opciones diagnósticas limitadas y altas tasas de mortalidad.
GeneCentric Therapeutics는 미국 의사 협회(American Medical Association, AMA)가 그들의 PurIST 췌장암 검사에 대해 독점 실험실 분석(PLA) 코드를 부여했다고 발표했습니다. 이 RNA 발현 기반 검사는 Tempus AI (NASDAQ: TEM)에게 라이센스가 부여되어 있으며, 췌장암 환자에 대한 치료를 알리고 개인화하는 데 설계되었습니다.
PurIST PLA 코드는 알고리즘 기반 분석을 위한 첫 번째 공통 절차 용어(CPT) 코드로, 실험실 개발 검사(LDT)에서 이전에 시퀀싱된 RNA 데이터의 분석을 위한 것입니다. 이는 AI 지원 알고리즘에 대한 환급에 있어 중요한 단계이며, PurIST의 상용화를 지원합니다.
이 검사는 절제할 수 없는 3기 또는 4기 췌장관 선암(PDAC) 환자의 종양을 기저(basal) 또는 고전(classical) 하위유형으로 분류하여, 진단 옵션이 제한적이고 치사율이 높은 암 유형에서 1차 치료를 안내하는 데 도움을 줍니다.
GeneCentric Therapeutics a annoncé que l'American Medical Association (AMA) a accordé un code d'Analyse de Laboratoire Propriétaire (PLA) pour leur test de cancer du pancréas PurIST. Ce test basé sur l'expression de l'ARN, licencié à Tempus AI (NASDAQ: TEM), est conçu pour informer et personnaliser le traitement des patients atteints de cancer du pancréas.
Le code PLA de PurIST est le premier code de Terminologie des Procédures Communes (CPT) créé pour l'analyse basée sur des algorithmes de données d'ARN précédemment séquencées d'un test développé en laboratoire (LDT). Cela représente une étape importante vers le remboursement pour les algorithmes activés par l'IA et soutient la commercialisation de PurIST.
Le test classe les tumeurs des patients atteints d'adénocarcinome canalaire pancréatique (PDAC) non résécable de stade III ou IV en sous-types basal ou classique, aidant à guider la thérapie de première ligne dans un type de cancer avec des options de diagnostic limitées et des taux de mortalité élevés.
GeneCentric Therapeutics hat bekannt gegeben, dass die American Medical Association (AMA) einen Proprietary Laboratory Analysis (PLA) Code für ihren PurIST-Pankreaskrebs-Test vergeben hat. Dieser auf RNA-Expression basierende Test, der an Tempus AI (NASDAQ: TEM) lizenziert ist, soll die Behandlung von Pankreaskrebs-Patienten informieren und personalisieren.
Der PurIST-PLA-Code ist der erste Common Procedural Terminology (CPT) Code, der für die algorithmusbasierte Analyse von zuvor sequenzierten RNA-Daten aus einem in einem Labor entwickelten Test (LDT) erstellt wurde. Dies stellt einen bedeutenden Schritt in Richtung Erstattung für KI-unterstützte Algorithmen dar und unterstützt die Kommerzialisierung von PurIST.
Der Test klassifiziert Tumoren von Patienten mit inoperablem Stadium III oder IV des duktalen Adenokarzinoms des Pankreas (PDAC) als entweder basal oder klassisch, was hilft, die Erstlinientherapie in einer Krebsart zu leiten, für die es eingeschränkte Diagnoseoptionen und hohe Sterblichkeitsraten gibt.
- Received PLA code from AMA for PurIST pancreatic cancer test
- First CPT code for algorithm-only analysis of previously sequenced LDT RNA data
- Significant step towards reimbursement for AI-enabled algorithms
- Collaboration with Tempus AI (NASDAQ: TEM) for commercial availability
- None.
Insights
The American Medical Association (AMA) granting a PLA code to GeneCentric’s PurIST Pancreatic Cancer Test is highly significant in the medical diagnostics industry. The PLA code facilitates reimbursement pathways, making it financially viable for broader clinical adoption. This code represents formal recognition of the test's validity and potential impact on clinical practice, enhancing its credibility among healthcare providers.
GeneCentric’s collaboration with Tempus AI emphasizes the importance of integrating advanced technological platforms for precision diagnostics. By leveraging RNA sequencing and AI-driven algorithms, the PurIST test can more accurately classify pancreatic tumors, aiding in the customization of treatment plans. This is critical given the high mortality rate of pancreatic cancer and the limited availability of effective first-line treatment options.
Ultimately, this development positions GeneCentric as a front-runner in the precision medicine space, potentially improving patient outcomes through more personalized treatment approaches.
From a financial perspective, the AMA’s approval of the PLA code for the PurIST test is a positive development for GeneCentric Therapeutics. This milestone paves the way for reimbursement, which is important for the test's commercial success. Coverage by insurance providers would significantly boost the adoption and utilization of the PurIST test across medical institutions.
The collaboration with Tempus AI, a publicly traded company, also adds a layer of financial credibility and market reach. Investors can view this as a strategic alignment that leverages the strengths of both companies—GeneCentric’s innovative diagnostic capabilities and Tempus AI’s robust data analytics platform. This synergy could translate into increased revenue streams and market penetration for both entities.
This news could positively influence investor sentiment and potentially lead to a higher valuation for GeneCentric and Tempus AI stocks in the short to mid-term.
The granting of a PLA code by the AMA to GeneCentric’s PurIST test is a critical advancement in the diagnostic test market. It signifies a shift towards more personalized and AI-driven diagnostic solutions, which is a growing trend in the healthcare industry. This move not only validates the clinical utility of the PurIST test but also accelerates its pathway to market adoption.
The test's ability to differentiate between basal and classical subtypes of pancreatic tumors means it can better guide treatment decisions, addressing a significant unmet need in the oncology market. Given the high mortality rate associated with pancreatic cancer, the PurIST test’s potential to improve treatment outcomes represents a valuable proposition for both clinicians and patients.
From a market perspective, this development could increase demand for RNA expression-based diagnostics. Companies operating in this space may see this as a benchmark, driving further innovation and competitive advancements.
PurISTSM is an RNA expression-based test licensed to Tempus AI to help inform and personalize treatment for patients with pancreatic cancer
The PurIST proprietary laboratory analysis (PLA) code is the first common procedural terminology (CPT) code created for algorithm-based analysis of previously sequenced RNA data from a laboratory developed test (LDT)
“Receipt of a PurIST-specific PLA test code further supports the significance of GeneCentric’s pipeline of next-generation AI-derived tests,” said Michael Milburn, PhD, President and CEO of GeneCentric Therapeutics. “This is a key step toward reimbursement and successful commercialization for PurIST, and we’re excited about the importance of this test in guiding first-line treatments for pancreatic cancer patients.”
Pancreatic cancer has one of the highest mortality rates among all major cancers, and there has been limited availability of validated diagnostic tests or biomarkers to guide first-line treatment selection. The PurIST test classifies the tumors of patients with unresectable stage III or stage IV pancreatic ductal adenocarcinoma (PDAC) as either a basal or classical subtype and can help guide first-line therapy.
About the PurIST Test
PurIST identifies the molecular subtype of patients with unresectable stage III or stage IV PDAC and classifies patients with PDAC into either a basal or classical subtype and may help inform first-line therapy management. Tempus and GeneCentric recently completed a new clinical validation study demonstrating that PurIST can be used to help predict overall survival of classical patients between standard-of-care first-line therapies, FOLFIRINOX and gemcitabine nab-paclitaxel. The PurIST test is available for ordering as part of the on-line Tempus HUB or via paper requisition forms for orders in
About Pancreatic Cancer
Pancreatic cancer is the 10th most commonly diagnosed cancer in the
About GeneCentric
GeneCentric Therapeutics, Inc., a leader in RNA-based genomic biomarker and next-generation companion diagnostics development, is based in
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Robin Fastenau
Robin.Fastenau@GeneCentric.com
Source: GeneCentric Therapeutics
FAQ
What is the PurIST pancreatic cancer test developed by GeneCentric Therapeutics?
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What problem does the PurIST test address in pancreatic cancer treatment?
