ALERCELL ANNOUNCES THE LAUNCH OF LENA PAN-MPN qPCR PANEL

Alercell increase its Leukemia Testing Platform

BOZEMAN, MONTANA, USA, February 1, 2024 /EINPresswire.com/ — Alercell, Inc., an innovative leader in molecular diagnostics, has recently unveiled its latest advancement, the RUO “LENA PAN-MPN – qPCR panel”. This cutting-edge diagnostic tool represents a significant leap in the detection of gene mutations associated with Myeloproliferative Neoplasms (MPN). Utilizing the sophisticated ARMS-PCR technique in tandem with a fluorescent probe, the LENA PAN-MPN qPCR Panel is designed for the in vitro qualitative detection of critical mutations in the JAK2, CALR, and MPL genes within genomic DNA.

What sets this diagnostic kit apart is its method of application – a minimally invasive liquid biopsy that requires just a simple blood draw. This approach not only enhances patient comfort but also expedites the testing process. The LENA PAN-MPN qPCR Panel is specifically engineered to detect and differentiate mutations including CALR TYPE1/TYPE2, MPL W515/S505N, and JAK2 V617F/K539L/exon 12 del, thereby aiding in the accurate clinical diagnosis of MPN.

The process is straightforward and efficient: following DNA extraction, the sample is analyzed using a PCR machine, with results being available in approximately three hours. Alercell, Inc.’s introduction of this product underscores their commitment to advancing medical diagnostics and improving patient care through innovative technology.

Clinical Utility and Patient Care

The clinical utility of the LENA PAN-MPN (Myeloproliferative Neoplasms) qPCR (quantitative Polymerase Chain Reaction) Panel test lies in its ability to accurately diagnose and differentiate among various types of myeloproliferative disorders. Myeloproliferative neoplasms are a group of diseases in which the bone marrow makes too many red blood cells, white blood cells, or platelets. These disorders include polycythemia vera (PV), essential thrombocythemia (ET), and primary myelofibrosis (PMF), among others. Here are some key aspects of the clinical utility of LENA PAN-MPN qPCR Panel test:

1. Early and Accurate Diagnosis: The test can detect genetic mutations associated with MPNs, such as JAK2 V617F, CALR, and MPL mutations. Identifying these mutations is crucial for an accurate diagnosis, allowing for early and appropriate treatment.

2. Differentiation of MPN Subtypes: By identifying specific mutations, the LENA PAN-MPN qPCR Panel helps in differentiating between various MPN subtypes. This is important for determining the prognosis and choosing the most effective treatment strategy.

3. Quantitative Analysis: The qPCR method provides quantitative data on the burden of disease-associated mutations. This information can be used to monitor disease progression or response to therapy over time.

4. Minimal Residual Disease (MRD) Monitoring: The sensitivity of qPCR enables the detection of minimal residual disease in patients who are in remission or undergoing treatment. Tracking MRD can help in making informed decisions about treatment adjustments.

5. Risk Stratification: Certain mutations detected by LENA PAN-MPN qPCR Panel are associated with different risks of disease progression. Identifying these mutations can aid in risk stratification and prognostication, guiding treatment choices.

6. Personalized Medicine: The test supports the principles of personalized medicine by providing mutation-specific information that can be used to tailor treatment to the individual patient. For instance, patients with certain CALR mutations may respond differently to treatment than those with JAK2 mutations.

7. Efficiency and Speed: qPCR is a fast and efficient technique, providing results more quickly than some other methods. This timely information can be critical in initiating treatment for patients with MPNs.

In summary, the LENA PAN-MPN qPCR Panel test is a powerful tool in the diagnosis and management of myeloproliferative neoplasms, offering benefits in accuracy, disease monitoring, and personalized treatment planning. Its ability to provide detailed genetic information helps clinicians make informed decisions, ultimately improving patient outcomes.

Frederic Scheer, chairman & CEO of Alercell, stated, “Alercell’s introduction of the RUO LENA PAN-MPC qPCR panel marks a significant advancement in the field of leukemia treatment. Our primary aim with this innovative tool is to revolutionize patient care by facilitating early detection and precise therapeutic selection. We understand that early diagnosis is critical in significantly improving survival rates for leukemia patients. At Alercell, we are committed to ensuring that every patient receives the highest chances of survival through cutting-edge technology and personalized care.”

Initial clinical verifications will start soon, we are pleased to introduce the test for commercial sale for Research Use Only to hospitals and various cancer centers for control purposes and for pharmaceutical surveillance studies.”

ABOUT ALERCELL

Alercell, Inc., a Montana company is a molecular diagnostics company pioneering novel therapeutics to discover, develop, and commercialize solutions for clinical unmet needs, with a primary focus in Oncology Diagnostic Testing .Alercell is a true innovator, disruptor, and leader in the field of preventative oncology. The company was founded with the aim of providing more accurate and timely diagnostic tools for cancer patients worldwide. Alercell’s mission is to make a difference in the fight against cancer by providing innovative and accurate diagnostic solutions that improve patient outcomes.

The Alercell^® mission is built on the foundation of “stopping it before it starts”. Our genetics-based testing is the first line of assault against cancer & leukemia and infectious diseases.

For more information, please visit: www.alercell.com and www.Lenadx.com

Forward-Looking Statements

This press release includes statements relating to Alercell RUO LENA PAN-MPN qPCR Panel and its launch for Research Use Only. These statements and other statements regarding ALERCELL future plans and goals constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control, and which may cause results to differ materially from expectations. Factors that could cause our results to differ materially from those described include, but are not limited to, our ability to successfully, timely and cost-effectively develop, seek and obtain regulatory clearance for and commercialize our product and services offerings, the rate of adoption of our products and services by hospitals, other healthcare providers and pharmaceutical companies, the success of our commercialization efforts for the Research Use Only product offering,

Frederic Scheer
ALERCELL INC
+1 406 920 8787
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