Applied DNA Positions TR8 PGx Testing Service as Pre-Emptive Testing for Safety of Fluoropyrimidine-Based Cancer Therapeutics Following Publication of Food and Drug Administration Safety Announcement
Applied DNA Sciences (NASDAQ:APDN) is repositioning its TR8™ PGx pharmacogenomics testing service to focus on specific use cases, starting with pre-emptive testing for DPYD gene variants. This initiative follows an FDA safety announcement regarding patients with DPYD genetic variants who may experience severe toxicities when taking fluoropyrimidine-based cancer drugs.
The company's TR8 PGx test, approved by the New York State Department of Health, can identify individuals with DPYD genotypes affecting DPD enzyme activity, important for metabolizing drugs like capecitabine and fluorouracil (5-FU). These medications, with approximately 924,000 prescriptions in 2022, are commonly used in treating various cancers including colorectal, breast, and cervical.
Statistics show that about 1 in 1,000 patients carry two DPYD gene variants causing DPD enzyme absence, while 3-8% of the population has one variant resulting in lower enzyme levels, with higher frequency in African Americans.
Applied DNA Sciences (NASDAQ:APDN) sta riposizionando il suo servizio di test farmacogenomici TR8™ PGx per concentrarsi su casi d'uso specifici, partendo dal test preventivo per le varianti genetiche del gene DPYD. Questa iniziativa segue un annuncio di sicurezza della FDA riguardante i pazienti con varianti genetiche DPYD che possono sperimentare tossicità severe quando assumono farmaci antitumorali a base di fluoropirimidina.
Il test TR8 PGx dell'azienda, approvato dal Dipartimento della Salute dello Stato di New York, può identificare gli individui con genotipi DPYD che influenzano l'attività dell'enzima DPD, importante per il metabolismo di farmaci come la capecitabina e il fluorouracile (5-FU). Questi farmaci, con circa 924.000 prescrizioni nel 2022, sono comunemente utilizzati nel trattamento di vari tumori, tra cui quelli del colon-retto, della mammella e della cervice.
Statistiche mostrano che circa 1 paziente su 1.000 porta due varianti del gene DPYD che causano l'assenza dell'enzima DPD, mentre il 3-8% della popolazione ha una variante che porta a livelli inferiori dell'enzima, con una frequenza maggiore tra gli afroamericani.
Applied DNA Sciences (NASDAQ:APDN) está reposicionando su servicio de pruebas farmacogenómicas TR8™ PGx para centrarse en casos de uso específicos, comenzando con pruebas preventivas para variantes genéticas del gen DPYD. Esta iniciativa sigue un anuncio de seguridad de la FDA sobre pacientes con variantes genéticas DPYD que pueden experimentar toxicidades severas al tomar medicamentos contra el cáncer basados en fluoropirimidina.
La prueba TR8 PGx de la compañía, aprobada por el Departamento de Salud del Estado de Nueva York, puede identificar a individuos con genotipos DPYD que afectan la actividad de la enzima DPD, importante para metabolizar medicamentos como la capecitabina y el fluorouracilo (5-FU). Estos medicamentos, con aproximadamente 924,000 recetas en 2022, se utilizan comúnmente en el tratamiento de varios tipos de cáncer, incluyendo el colorrectal, de mama y cervical.
Las estadísticas muestran que aproximadamente 1 de cada 1,000 pacientes lleva dos variantes del gen DPYD que causan la ausencia de la enzima DPD, mientras que el 3-8% de la población tiene una variante que resulta en niveles más bajos de la enzima, con una frecuencia mayor en afroamericanos.
Applied DNA Sciences (NASDAQ:APDN)는 TR8™ PGx 약물유전체 검사 서비스를 특정 사용 사례에 맞춰 재편성하고 있으며, DPYD 유전자 변이에 대한 예방적 검사를 시작합니다. 이 이니셔티브는 DPYD 유전자 변이를 가진 환자들이 플루오로피리미딘 기반의 항암제를 복용할 때 심각한 독성을 경험할 수 있다는 FDA의 안전 공지에 따른 것입니다.
회사의 TR8 PGx 검사는 뉴욕주 보건부의 승인을 받아 DPD 효소 활성을 영향을 미치는 DPYD 유전자형을 가진 개인을 식별할 수 있습니다. 이는 카페시타빈과 플루오로우라실(5-FU)과 같은 약물을 대사하는 데 중요합니다. 이러한 약물은 2022년에 약 924,000건의 처방이 이루어졌으며, 대장암, 유방암 및 자궁경부암을 포함한 다양한 암 치료에 일반적으로 사용됩니다.
통계에 따르면 약 1,000명의 환자 중 1명은 DPD 효소가 결여된 두 개의 DPYD 유전자 변이를 보유하고 있으며, 인구의 3-8%는 효소 수치가 낮은 하나의 변이를 가지고 있으며, 이는 아프리카계 미국인에서 더 높은 빈도로 나타납니다.
Applied DNA Sciences (NASDAQ:APDN) repositionne son service de test pharmacogénomique TR8™ PGx pour se concentrer sur des cas d'utilisation spécifiques, en commençant par le test préventif pour les variantes génétiques du gène DPYD. Cette initiative fait suite à une annonce de sécurité de la FDA concernant les patients avec des variantes génétiques DPYD qui peuvent éprouver des toxicités sévères lors de la prise de médicaments anticancéreux à base de fluoropyrimidine.
Le test TR8 PGx de l'entreprise, approuvé par le Département de la Santé de l'État de New York, peut identifier les individus ayant des génotypes DPYD affectant l'activité de l'enzyme DPD, importante pour le métabolisme de médicaments comme la capécitabine et le fluorouracile (5-FU). Ces médicaments, avec environ 924 000 prescriptions en 2022, sont couramment utilisés pour traiter divers cancers, y compris colorectal, mammaire et cervical.
Les statistiques montrent qu'environ 1 patient sur 1 000 porte deux variantes du gène DPYD causant l'absence de l'enzyme DPD, tandis que 3 à 8 % de la population a une variante entraînant des niveaux d'enzyme plus bas, avec une fréquence plus élevée chez les Afro-Américains.
Applied DNA Sciences (NASDAQ:APDN) positioniert seinen TR8™ PGx Pharmakogenomik-Testdienst neu, um sich auf spezifische Anwendungsfälle zu konzentrieren, beginnend mit präventiven Tests auf DPYD-Genvarianten. Diese Initiative folgt einer Sicherheitsankündigung der FDA bezüglich Patienten mit DPYD-Genvarianten, die bei der Einnahme von fluoropyrimidinhaltigen Krebsmedikamenten schwerwiegende Toxizitäten erfahren können.
Der TR8 PGx-Test des Unternehmens, der vom Gesundheitsministerium des Bundesstaates New York genehmigt wurde, kann Personen mit DPYD-Genotypen identifizieren, die die Aktivität des DPD-Enzyms beeinflussen, das wichtig für den Metabolismus von Medikamenten wie Capecitabin und Fluorouracil (5-FU) ist. Diese Medikamente, mit etwa 924.000 Verschreibungen im Jahr 2022, werden häufig zur Behandlung verschiedener Krebsarten, einschließlich Kolorektalkrebs, Brustkrebs und Gebärmutterhalskrebs, eingesetzt.
Statistiken zeigen, dass etwa 1 von 1.000 Patienten zwei DPYD-Genvarianten trägt, die zur Abwesenheit des DPD-Enzyms führen, während 3-8% der Bevölkerung eine Variante aufweisen, die zu niedrigeren Enzymspiegeln führt, wobei die Häufigkeit bei Afroamerikanern höher ist.
- NY State Department of Health approved TR8 PGx test as a laboratory-developed test
- Large market potential with 924,000 prescriptions for target medications in 2022
- Strategic expansion into indication-specific testing subpanels for oncology, cardiology, and psychiatry
- Requires complete business strategy revamp for pharmacogenomics testing
- Faces potential competition in an established medical testing market
Insights
The FDA safety announcement regarding fluoropyrimidine metabolism creates a timely opportunity for Applied DNA's TR8 PGx test. The clinical significance is substantial: DPYD variants directly impact enzyme activity essential for metabolizing widely-used chemotherapeutics capecitabine and 5-FU. With complete DPD enzyme deficiency occurring in approximately 1 in 1,000 individuals and reduced activity affecting 3-8% of the population, pre-emptive genetic testing addresses a critical patient safety concern.
The strategic shift to indication-specific subpanels is clinically sound. By focusing on specific gene-drug interactions with clear actionability, Applied DNA addresses a key barrier to pharmacogenomic testing adoption. Their NYSDOH-approved 120-target panel covering 33+ drug metabolism genes provides comprehensive capability for this targeted approach.
The market is substantial - nearly
This repositioning aligns with growing recognition that pharmacogenomic testing delivers highest utility when focused on specific, high-risk scenarios rather than broad screening. The planned expansion into oncology, cardiology, and psychiatry targets areas where pharmacogenomic testing has demonstrated clear clinical value in improving patient outcomes.
Applied DNA's strategic pivot toward indication-specific testing represents a potential inflection point in their commercialization strategy. By segmenting their comprehensive 120-target panel into targeted subpanels, the company addresses a common challenge in diagnostic commercialization: demonstrating clear clinical utility and economic value to drive adoption.
The fluoropyrimidine metabolism testing market represents a defined opportunity with approximately 924,000 annual prescriptions. With
This repositioning potentially improves go-to-market efficiency. Rather than marketing a broad panel with variable relevance across specialties, targeted subpanels allow for focused messaging to specific physician groups (oncologists initially, with cardiology and psychiatry to follow). This approach may reduce sales cycle complexity and improve conversion rates.
From a revenue perspective, while subpanel testing might generate lower per-test revenue than comprehensive panels, higher volumes and improved adoption rates could drive overall revenue growth. The strategic shift suggests Applied DNA is prioritizing market penetration over maximizing per-test economics - a reasonable approach for building testing volume and clinical validation.
The pharmacogenomics market has seen mixed commercial success, but targeted applications with clear safety implications and regulatory backing have demonstrated better adoption. This strategic refocus positions the company to capitalize on growing precision medicine initiatives while addressing specific clinical needs.
- Company Revamps Pharmacogenomics Go-To-Market Strategy, Targets Validated PGx Assay Towards Specific Use Cases -
STONY BROOK, NY / ACCESS Newswire / April 1, 2025 / Applied DNA Sciences, Inc. (NASDAQ:APDN) (Applied DNA or the "Company"), a leader in PCR-based DNA technologies, today announced that Applied DNA Clinical Labs (ADCL), its wholly-owned clinical laboratory subsidiary, is repositioning its TR8™ PGx pharmacogenomics testing service to offer tailored subpanels for indication-specific use cases in addition to full panel testing. The first subpanel under ADCL's new go-to-market strategy is for the pre-emptive testing of patients with genetic variants of the DPYD gene that correlate to potentially reduced or absent DPD enzyme activity necessary to metabolize fluoropyrimidines, specifically capecitabine (branded Xeloda) and fluorouracil (5-FU), two chemotherapy drugs that are widely used as part of the standard of care treatment for patients with certain cancers. The decision by ADCL follows a recent safety announcement by the Food and Drug Administration (FDA) in which the agency highlighted that patients with certain DPYD genetic variants are potentially poor or intermediate metabolizers of these two medications due to DPD enzyme deficiencies and risk drug overexposure and the potential to experience severe, and at times fatal, toxicities when taking them. ADCL's TR8 PGx test, a 120-target pharmacogenomics panel approved by the New York State Department of Health as a laboratory-developed test comprising more than 33 drug metabolism-related genes, can identify individuals with DPYD genotypes that result in potentially reduced or absent DPD enzyme activity.
Capecitabine and 5-FU are used for the treatment of colorectal, esophageal, stomach, pancreatic, breast, and cervical cancers. Approximately 924,000 prescriptions were written for fluorouracil and capecitabine in 2022, according to the most recent drug usage data available.1 Approximately 1 in 1,000 patients carry two copies of a variant in the DPYD gene, resulting in the absence of the DPD enzyme. Between 3 percent and 8 percent of the general population has one copy of a variant associated with lower levels of the DPD enzyme, showing up more frequently in African Americans.2 These genotypes are at higher risk of adverse side effects from fluorouracil and capecitabine.
"The FDA's safety announcement underscores the value of genetic testing to guide treatment decisions and improve patient outcomes, and highlights the breadth of our TR8 PGx test and its potential to influence clinical decision-making across multiple therapeutic areas. To this end, we plan to introduce additional TR8 PGx subpanels that target indication-specific use cases where genetic testing has a high correlation with drug efficacy and safety, such as in oncology, cardiology, and psychiatry. We believe this revised go-to-market strategy can lower the barrier to adoption of our PGx testing services and provides enhanced utility to institutions, clinicians, and their patients," stated Dr. James A. Hayward, CEO of Applied DNA.
About TR8™ PGx - Pharmacogenomic Testing
The TR8 PGx test analyzes 120 genetic targets across more than 33 genes to inform healthcare providers about how a patient may respond to a wide range of drug therapies used to treat a variety of conditions, such as cardiovascular, oncology, psychiatric, and pain management. Equipped with information about a patient's genome-based response to medications, healthcare providers can make more informed decisions when selecting prescription medications, thereby optimizing healthcare quality and efficacy.
The test is administered via a simple cheek swab. The TR8 PGx testing service offered by ADCL was approved as a laboratory-developed test by the New York State Department of Health (NYSDOH) in June 2024.
Learn more about TR8 PGx here.
Citations:
1 Bcps, S. P. K. P. (n.d.). Fluorouracil - Drug usage Statistics, ClinCalc DrugStats Database. https://clincalc.com/DrugStats/Drugs/Fluorouracil
2 "Mass General Brigham Becomes Latest US Health System to Adopt Pretreatment DPYD Testing." Precision Medicine Online, January 16, 2025. https://www.precisionmedicineonline.com/precision-oncology/mass-general-brigham-becomes-latest-us-health-system-adopt-pretreatment-dpyd
About Applied DNA Sciences
Applied DNA Sciences is a biotechnology company developing technologies to produce and detect deoxyribonucleic acid ("DNA"). Using the polymerase chain reaction ("PCR") to enable both the production and detection of DNA. The Company operates in two business markets: (i) the enzymatic manufacture of synthetic DNA for use in the production of nucleic acid-based therapeutics and the development and sale of a proprietary RNA polymerase ("RNAP") for use in the production of mRNA therapeutics; and (ii) the detection of DNA and RNA in molecular diagnostics and genetic testing services.
Visit adnas.com for more information. Follow us on X and LinkedIn.
Forward-Looking Statements
The statements made by Applied DNA in this press release may be "forward-looking" in nature 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. Forward-looking statements describe Applied DNA's future plans, projections, strategies, and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to the Company's history of net losses, limited financial resources, unknown future demand for its TR8TM PGx testing service, the unknown amount of revenues and profits that will result from its TR8 PGx testing service, the unknown status of FDA's continued enforcement discretion with respect to laboratory developed tests including laboratory developed PGx tests, as well as various other factors detailed from time to time in Applied DNA's SEC reports and filings, including its Annual Report on Form 10-K filed on December 17, 2024, its Quarterly Report on Form 10-Q filed on February 13, 2025, and other reports it files with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.
Applied DNA Sciences Contact:
Investor Relations contact: Sanjay M. Hurry, 917-733-5573, sanjay.hurry@adnas.com
Web: adnas.com
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SOURCE: Applied DNA Sciences, Inc.
View the original press release on ACCESS Newswire
FAQ
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