BOZEMAN, Mont., April 24, 2023 /PRNewswire/ — ALERCELL, INC. announced today that it has introduced a molecular Leukemia diagnostic platform. LENA Molecular Dx Leukemia Platform is a core group of 12 molecular diagnostic tests specialized in Leukemia early diagnostic, treatment guidance and MRD (Minimal residual disease) monitoring. All the tests are next generation DNA sequencing tests but can be processed on a standard qPCR machine bringing easy access to a lot of data efficiently and quickly to bring a better outcome to patients.
Several of the tests are Research Use Only (RUO) such as the RUO LENA Q51® introduced by Alercell in January 2023. LENA Q51® is the most comprehensive test and covers all the other tests but Alercell wanted to give access to all tests thru the creation of the Platform. Alercell R&D team is constantly working to add new tests to cover all the aspects of Leukemia testing to provide practitioners with every single test available in one place.
Alercell is making sure that all the tests are offered at very competitive pricing. Alercell strong belief is that giving access to many patients, hospitals and cancer centers to quality testing at a limited price will increase the quantity of patients tested, thus will permit early detection and fast treatment of Leukemia. Practitioners should take treatment decisions based on medical data not on costs or insurance consideration.
The tests have an easy-to-use protocol and can be run on standard qPCR equipment and are designed to handle the workflow in a clinical microbiology lab environment. The tests employ industry standard PCR and DNA purification technology.
Frederic Scheer, chairman & CEO of Alercell, stated, “This new platform was designed to create a one-stop-shop for Leukemia, where practitioners do not need to look for many different manufacturers. Our goal at Alercell is to become the reference for Leukemia and offer a complete solution. Our R&D team is working on additional tests to add to the platform in the months and years to come. I believe that several of the tests designed to improve patient outcomes will assist practitioners in selecting the appropriate therapeutics for Leukemia patients. Early detection drastically enhances the survival rates of patients and Alercell is focusing on making sure that we give every patient the best chances of survival.
“Several of the Tests are Research Use only (RUO) but Initial clinical verifications will start soon, we are pleased to introduce the tests for commercial sale for Research Use Only to hospitals and various cancer centers for control purposes and for pharmaceutical surveillance studies.”
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 in-vitro Diagnostic Testing and Neuroscience. 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.
This press release includes statements relating to Alercell RUO LENA Q51 ® 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, the effect on our business of existing and new regulatory requirements, and other economic and competitive factors. You are cautioned not to place undue reliance on these forward-looking statements, which are based on our expectations as of the date of this press release and speak only as of the date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
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SOURCE Alercell, Inc.