Healthcare Industry News: FDA
News Release - May 25, 2022
Alercell Starts to Distribute Human Papilloma Virus (HPV) DNA Test
BOZEMAN, Mont., May 25, 2022 -- (Healthcare Sales & Marketing Network) -- Alercell, announced today that it will begin distributing an HPV DNA based test kit: "Meltpro HPV genotype test" the test is based on DNA sequencing analysis.The Meltpro HPV genotype test follows some simple steps in detecting high-risk human papillomavirus. The analysis of genotypes involves a single step procedure almost similar to a real-time polymerase chain reaction. It takes two and half hours to detect and analyze the high-risk genotypes.
Alercell
Alercell
Long-lasting infections with high-risk HPVs can cause cancer in parts of the body where HPV infects cells, such as in the cervix, oropharynx, anus, penis, vagina, and vulva.
HPV infects the squamous cells that line the inner surfaces of these organs. For this reason, most HPV-related cancers are a type of cancer called squamous cell carcinoma. Some cervical cancers come from HPV infection of gland cells in the cervix and are called adenocarcinomas
Cervical carcinoma is the second in rank of the cancers occurring in females after breast cancer. The age of onset of cervical cancer is between twenty-six to thirty years and between forty to fifty years.
"A woman dies from cervical cancer every 2 minutes globally WHO is predicting that the death rate from cervical cancer will increase by nearly 50% by 2030, to me this is intolerable," declared Frederic Scheer, CEO of Alercell.
"Similar to the recent announcement we did on the Leukemia Fusion Gene Kit, the valuable aspect of the DNA test is the unique combination of accuracy and speed," said Dr. Alexandre Scheer MD Chief Medical Officer of Alercell. "The approach is not only innovative but could create a tremendous tool to fight HPV related cancers."
The traditional approach is done through blood tests and cytology analysis while the Meltpro HPV DNA test analyzed the specimen through a standard PCR machine eliminating the risk of human interpretation. Results can be obtained in less than three hours at a fraction of the costs of the traditional approach. The Meltpro HPV test reagent can realize single-tube genotyping of all 14 types. This is based on a patented MMCA technology. Until now the existing HPV DNA reagents were able only to detect HPV16 and HPV18 in a single tube.
This new technology is possible with very high melting curve function of the instrumentation used for the tests. Alercell is offering the instrumentation to go along with Meltpro HPV Tests both the SLAN 96S and the new Sanity 2.0 designed by Zeesan Biotech.
"It is important to give practitioners and patients a fast and affordable solution to all the life-threatening conditions that are ravaging the lives of so many," added Scheer
The Meltpro HPV genotype test kit will start as a "RUO" Research Use Only while waiting for the final FDA certification to expand the distribution around the country. The test is already available in Europe with a full CE certification.
ABOUT ALERCELL
Alercell, Inc is a molecular diagnostics company that provides cancer and leukemia rapid tests to diagnose life-threatening illnesses at an early stage. 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. Alercell is a Biotechnology company based in Bozeman, Montana with a satellite office in New York City.
For more information, please visit: www.alercell.com
Forward Looking Statements
Certain statements made in this release are "forward looking statements" within the meaning of the "safe harbor" provisions of the United States Private Securities Litigation Reform Act of 1995. When used in this press release, the words "estimates," "projected," "expects," "anticipates," "forecasts," "plans," "intends," "believes," "seeks," "may," "will," "should," "future," "propose" and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance, conditions or results and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside Alercell 's control, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. Important factors, among others, that may affect actual results or outcomes include the inability to complete the proposed business combination or the Extension; the inability to recognize the anticipated benefits of the proposed business combination; costs related to any business combination; Alercell's ability to manage growth; Alercell's ability to execute its business plan; the timing of revenues from existing customers, including uncertainties related to the ability of Alercell's customers to commercialize their products and the ultimate market acceptance of these products; the uncertain impact of the COVID-19 pandemic on Alercell's and its customers' businesses; uncertainties related to Alercell's estimates of the size of the markets for its products; the rate and degree of market acceptance of Alercell 's products; the success of other competing products and services that exist or may become available; Alercell's ability to identify and integrate acquisitions; rising costs adversely affecting Alercell's profitability; uncertainties related to Alercell's potential litigation involving Alercell or the validity or enforceability of Alercell's intellectual property; and general economic and market conditions impacting demand for Alercell's products and services. Other factors include the possibility that any proposed business combination does not close, including due to the failure to receive required security holder approvals, or the failure of other closing conditions. Alercell does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
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Source: Alercell
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