COMPANY:

Alercell

"ALERCELL, INC. is proud to announce the introduction of the LENA S1® diagnostic test, a cutting-edge tool for the early detection of small-cell lung cancer, available at this time solely for research purposes. Recognizing the challenge of diagnosing lung cancer at its nascent stage, due to the absence of symptoms until the disease has significantly progressed, LENA S1® emerges as a pivotal advancement."

"Alercell, Inc...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."

"Alercell, Inc...proudly announces an exclusive patent license agreement with Columbia University...Under the license agreement, Alercell will spearhead the development of a novel diagnostic test for Leukemia which uses terminal erythroid differentiation (TED) as a clinically significant indicator for prognostic classification in patients with myeloid malignancies."

"ALERCELL, INC. announced...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."

"ALERCELL, INC. announced...that it has introduced a new Research Use Only (RUO) LENA Q51® Leukemia diagnostic test for commercial sale. Lena Q51® was developed to detect up to 51 genes mutations associated with Leukemia...The RUO LENA Q51® will be available while the company completes clinical trials and regulatory submissions to support U.S. Food and Drug Administration (FDA) approval for broader clinical use."

"Alercell is all set to launch LENA Q51® in January 2023. A leukemia diagnostic test based on sequencing DNA will detect up to 51 Genes mutations in Leukemia patients...LENA Q51® will be introduced as a RUO not for diagnostic purpose to selected cancer institutes and universities to start with."

"Alercell® announced...that it has started the distribution of AmoyDx ROS1 Gene Fusion Detection Kit. Part of the master AmoyDx distribution agreement signed last month...The AmoyDx® ROS1 Gene Fusions Detection Kit is a real-time PCR assay for qualitative detection of 14 ROS1 gene fusions in human total RNA extracted from formalin-fixed paraffin-embedded (FFPE) tumor tissues in NSCLC patients."

"Alercell® announced today that it has entered into a master distribution agreement with Amoy Diagnostics Co., Ltd (AmoyDx)...The master distribution agreement enables Alercell® to introduce to the United States market several innovative DNA sequencing cancer tests...The first tests to be introduced under the Agreement include: Pan Lung Cancer PCR Panel, EML4-ALK Fusion Gene Detection Kit, BRCA Pro Panel, and the Human Papillomavirus (HPV) Genotyping Detection Kit. These molecular diagnostic tests are all introduced as RUOs (Research Use Only) and are the most advanced next generation DNA sequencing tests in various fields to tackle, Lung Cancer, Breast Cancer , Ovarian Cancer and Cervical Cancer screening."

"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, announced...that it will begin distributing a Leukemia Fusion Gene Screening and Genotyping Kit created and manufactured by Zeesan, a longtime partner of Alercell...The Leukemia Fusion Gene Screening and Genotyping Kit will start as a 'RUO' Research Use Only while waiting for the final FDA certification to expand the distribution around the country."