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Precipio Expands Bloodhound™ MPN Panel by Adding CALR Mutation Subtyping

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Precipio, Inc. (NASDAQ: PRPO) has launched an enhanced version of its Bloodhound MPN (Myeloproliferative Neoplasm) panel that can now differentiate between CALR type 1 and type 2 mutations. This advancement aligns with the latest National Comprehensive Cancer Network (NCCN) guidelines released in August 2024. The new panel is the only quantitative PCR-based panel on the market that distinguishes between CALR types alongside other relevant genes for MPN evaluation.

The inclusion of CALR mutation subtyping is significant for MPN patient care, as it can influence treatment strategies and outcomes. CALR gene mutations are prevalent in various myeloproliferative neoplasms and play a critical role in disease prognosis and therapeutic decision-making. The distinction between CALR types can indicate disease progression severity and inform physicians on specific treatment needs.

Precipio, Inc. (NASDAQ: PRPO) ha lanciato una versione avanzata del suo pannello Bloodhound MPN (Neoplasie Mieloproliferative) che ora è in grado di differenziare tra mutazioni di tipo 1 e tipo 2 di CALR. Questo progresso è in linea con le ultime linee guida del National Comprehensive Cancer Network (NCCN) pubblicate nell'agosto 2024. Il nuovo pannello è il primo pannello quantitativo basato su PCR disponibile sul mercato che distingue tra i tipi di CALR insieme ad altri geni rilevanti per la valutazione delle MPN.

L'inclusione della sottotipizzazione delle mutazioni CALR è significativa per la cura dei pazienti con MPN, poiché può influenzare le strategie di trattamento e gli esiti. Le mutazioni del gene CALR sono diffuse in varie neoplasie mieloproliferative e giocano un ruolo critico nella prognosi della malattia e nel processo decisionale terapeutico. La distinzione tra i tipi di CALR può indicare la gravità della progressione della malattia e fornire ai medici indicazioni su specifiche necessità di trattamento.

Precipio, Inc. (NASDAQ: PRPO) ha lanzado una versión mejorada de su panel Bloodhound MPN (Neoplasia Mieloproliferativa) que ahora puede diferenciar entre mutaciones de tipo 1 y tipo 2 de CALR. Este avance se alinea con las últimas guías del National Comprehensive Cancer Network (NCCN) publicadas en agosto de 2024. El nuevo panel es el único panel cuantitativo basado en PCR en el mercado que distingue entre los tipos de CALR junto con otros genes relevantes para la evaluación de MPN.

La inclusión de la subtipificación de mutaciones de CALR es significativa para el cuidado de los pacientes de MPN, ya que puede influir en las estrategias de tratamiento y en los resultados. Las mutaciones del gen CALR son prevalentes en varias neoplasias mieloproliferativas y desempeñan un papel fundamental en el pronóstico de la enfermedad y en la toma de decisiones terapéuticas. La distinción entre los tipos de CALR puede indicar la gravedad de la progresión de la enfermedad e informar a los médicos sobre necesidades de tratamiento específicas.

Precipio, Inc. (NASDAQ: PRPO)는 이제 CALR 종류 1 및 2 변이를 구분할 수 있는 향상된 버전의 Bloodhound MPN(골수증식성신생물) 패널을 출시했습니다. 이 발전은 2024년 8월에 발표된 최신 국가종합암망(NCCN) 가이드라인과 일치합니다. 새로운 패널은 MPN 평가를 위해 다른 관련 유전자와 함께 CALR 유형을 구분하는 유일한 정량적 PCR 기반 패널입니다.

CALR 변이 하위 유형의 포함은 MPN 환자 치료에 있어 중요하며, 이는 치료 전략 및 결과에 영향을 미칠 수 있습니다. CALR 유전자 변이는 다양한 골수증식성신생물에서 흔히 발견되며, 질병의 예후와 치료 결정에 중요한 역할을 합니다. CALR 유형 간의 구분은 질병 진행의 심각성을 나타내고 의사에게 특정 치료 필요성에 대한 정보를 제공할 수 있습니다.

Precipio, Inc. (NASDAQ: PRPO) a lancé une version améliorée de son panneau Bloodhound MPN (Néoplasie myéloproliférative) qui peut désormais différencier entre les mutations de type 1 et de type 2 de CALR. Cette avancée est conforme aux dernières directives du National Comprehensive Cancer Network (NCCN) publiées en août 2024. Le nouveau panneau est le seul panneau basé sur PCR quantitative sur le marché qui distingue entre les types de CALR ainsi que d'autres gènes pertinents pour l'évaluation des MPN.

L'inclusion de la sous-classification des mutations CALR est significative pour les soins aux patients MPN, car cela peut influencer les stratégies de traitement et les résultats. Les mutations du gène CALR sont courantes dans divers néoplasies myéloprolifératives et jouent un rôle crucial dans le pronostic de la maladie et la prise de décision thérapeutique. La distinction entre les types de CALR peut indiquer la gravité de la progression de la maladie et informer les médecins sur des besoins spécifiques de traitement.

Precipio, Inc. (NASDAQ: PRPO) hat eine verbesserte Version seines Bloodhound MPN (Myeloproliferative Neoplasie) Panels auf den Markt gebracht, das jetzt CALR Typ 1 und Typ 2 Mutationen unterscheiden kann. Dieser Fortschritt entspricht den neuesten Richtlinien des National Comprehensive Cancer Network (NCCN), die im August 2024 veröffentlicht wurden. Das neue Panel ist das einzige quantitative PCR-basierte Panel auf dem Markt, das zwischen CALR Typen sowie anderen relevanten Genen zur Bewertung von MPN unterscheidet.

Die Einbeziehung der CALR-Mutationsuntertypisierung ist für die Versorgung von MPN-Patienten von Bedeutung, da sie die Behandlungsstrategien und Ergebnisse beeinflussen kann. CALR-Gene-Mutationen sind in verschiedenen myeloproliferativen Neoplasien verbreitet und spielen eine entscheidende Rolle bei der Prognose der Krankheit und der therapeutischen Entscheidungsfindung. Der Unterschied zwischen den CALR-Typen kann die Schwere des Krankheitsfortschritts anzeigen und Ärzten spezifische Behandlungsbedürfnisse mitteilen.

Positive
  • Launch of enhanced Bloodhound MPN panel with CALR type 1 and 2 mutation differentiation
  • Alignment with latest NCCN guidelines (August 2024)
  • Only quantitative PCR-based panel on the market with CALR subtyping capability
  • Potential for improved treatment strategies and patient outcomes in MPN care
Negative
  • None.

Insights

The expansion of Precipio's Bloodhound™ MPN Panel to include CALR mutation subtyping is a significant development in the field of cancer diagnostics. This advancement aligns with the latest NCCN guidelines and addresses a critical need in MPN patient care. The ability to distinguish between CALR type 1 and type 2 mutations provides clinicians with more precise information for prognosis and treatment decisions.

Key points to consider:

  • Precipio is now offering the only quantitative PCR-based panel that differentiates CALR subtypes alongside other relevant MPN genes.
  • This enhancement can potentially improve patient outcomes by enabling more targeted therapies, especially for patients with dual mutations.
  • The update demonstrates Precipio's commitment to staying at the forefront of diagnostic technology, which could strengthen its market position.

While this advancement is promising, investors should note that the impact on Precipio's financials may take time to materialize as adoption of the new panel grows. The company's ability to market this unique offering effectively will be important for translating this innovation into revenue growth.

The unique assay enables laboratories to provide clinicians with more informed treatment decisions for their patients

NEW HAVEN, Conn., Oct. 08, 2024 (GLOBE NEWSWIRE) -- Specialty cancer diagnostics company Precipio, Inc. (NASDAQ: PRPO) announces the launch of a new version of its Bloodhound MPN (Myeloproliferative Neoplasm) panel that is now able to distinguish between CALR type 1 and type 2 mutations. The CALR mutation data plays a critical role in disease prognosis and therapeutic decision-making. This differentiation aligns with the latest National Comprehensive Cancer Network (NCCN) guidelines released in August of this year (Version 2.2024—August 8, 2024).

This is the only quantitative PCR-based panel of its kind on the market that distinguishes between CALR Type 1 and Type 2 alongside the other genes relevant to the molecular evaluation of MPN.

“As science and discovery constantly evolve the diagnostic world, Precipio is committed to maintaining its competitive advantage and being at the forefront of our industry,” said Ilan Danieli, Precipio CEO. “Our customers and their patients will continue to benefit from access to cutting-edge technologies combined with the highest clinical value, enhancing patient care.”

Clinical Significance of CALR Subtyping in MPN Management
The inclusion of CALR mutation subtyping is a direct response to the evolving landscape of MPN patient care where understanding the specific type of CALR mutation can influence treatment strategies and outcomes.

The CALR gene mutation is prevalent in various myeloproliferative neoplasms and plays a critical role in disease prognosis and therapeutic decision-making. The distinction between CALR type 1 and type 2 can indicate the severity of disease progression (prognosis) and inform the physician on the specific treatment needed to suit the patient’s situation. Furthermore, for patients with dual mutations (e.g. JAK2 & CALR), the identification of the subtype CALR mutation present can impact the selection of targeted therapies.

With the recent updates from the NCCN, healthcare providers are looking for more detailed information regarding CALR mutations, allowing them to better manage MPN patient care. Precipio’s new Bloodhound MPN assay provides them with exactly what they need to help specify an MPN subtype and to determine which CALR-positive patients may respond to CALR-targeted therapies.

Please click here for more information about Precipio’s Bloodhound MPN panel and the new CALR subtyping capabilities or contact us at contact@precipiodx.com.

About Precipio

Precipio is a healthcare biotechnology company focused on cancer diagnostics. Our mission is to address the pervasive problem of cancer misdiagnoses by developing solutions in the form of diagnostic products and services. Our products and services deliver higher accuracy, improved laboratory workflow, and ultimately better patient outcomes, which reduce healthcare expenses. Precipio develops innovative technologies in our laboratory where we design, test, validate, and use these products clinically, improving diagnostic outcomes. Precipio then commercializes these technologies as proprietary products that serve the global laboratory community and further scales Precipio’s reach to eradicate misdiagnosis. For more information, please visit www.precipiodx.com.

Please follow us on LinkedIn, Twitter @PrecipioDx and on Facebook.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. 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 targets set herein and related timing.

Except for historical information, statements about future volumes, sales, growth, costs, cost savings, margins, earnings, earnings per share, diluted earnings per share, cash flows, plans, objectives, expectations, growth or profitability are forward-looking statements based on management’s estimates, beliefs, assumptions and projections. Words such as “could,” “may,” “expects,” “anticipates,” “will,” “targets,” “goals,” “projects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “predicts,” and variations on such words, and similar expressions that reflect our current views with respect to future events and operational, economic and financial performance, are intended to identify such forward-looking statements. These forward-looking statements are only predictions 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 our 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, the important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and our other reports filed with the U.S. Securities and Exchange Commission. Any such forward-looking statements represent management’s estimates as of the date of this press release only. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.


FAQ

What new feature has Precipio (PRPO) added to its Bloodhound MPN panel?

Precipio has added the ability to distinguish between CALR type 1 and type 2 mutations in its Bloodhound MPN panel.

How does the new CALR subtyping in Precipio's (PRPO) panel align with industry standards?

The new CALR subtyping aligns with the latest National Comprehensive Cancer Network (NCCN) guidelines released in August 2024.

What is the clinical significance of CALR subtyping in Precipio's (PRPO) MPN panel?

CALR subtyping can influence treatment strategies, indicate disease progression severity, and inform specific treatment needs for MPN patients.

How does Precipio's (PRPO) new Bloodhound MPN panel compare to other products on the market?

It is the only quantitative PCR-based panel on the market that distinguishes between CALR Type 1 and Type 2 alongside other genes relevant to MPN evaluation.

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