BOZEMAN July 12, 2020 – Alercell® announced today that it has entered into a master distribution agreement with Amoy Diagnostics Co., Ltd (AmoyDx), a China based innovative molecular diagnostics company with shares traded on the Shenzhen Stock Exchange (SZSE: 300685), 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. These tests target gene mutations/fusions and serve as cancer biomarker in several fields, part of the process includes a service giving access to AmoyDx NGS Data Analysis System (ANDAS).
ANDAS allows a fast DNA sequencing analysis and comparison with an existing database. The AmoyDx® BRCA Pro Panel is a next-generation sequencing (NGS) based in vitro diagnostic assay intended for qualitative detection and classification of single nucleotide variants (SNVs), insertions and deletions (InDels), and large rearrangements (LRs) in protein coding regions, intron/exon boundaries, some introns and UTR regions of the BRCA1 and BRCA2 genes, using DNA isolated from peripheral whole blood or formalin-fixed paraffin embedded (FFPE) tumor tissue specimens.
The sequencing data can be analyzed by ANDAS to detect the genomic variants in the target region. It is efficient and allow access to large amount of data which benefit and speed up the diagnostic process.
“Amoy Diagnostics is a real innovator in the field of cancer biomarker detection, and we are proud to open the US market to these advanced tests. It is just the start of a long collaboration, and we are excited as some universities are already testing the products” said Frederic Scheer, Alercell® CEO. AmoyDx is a well-known biotech company that has several existing agreements with well-known players such as Astra Zeneca, Merck and other large biotech companies.
The tests are available now for distribution at Alercell corporate office in Montana.
About Amoy Diagnostics Co., Ltd.
Amoy Diagnostics Co., Ltd. (SZSE: 300685) is a leading biotech company which pioneered the development and commercialization of cancer diagnostics in China. It is the largest provider of molecular diagnostics products for personalized healthcare in China, as well as a service center for oncology biomarker analysis. AmoyDx has a market-leading portfolio of molecular tests and is the therapy diagnostics partner for several major multinational pharmaceutical companies offering precision therapies for cancer.
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.
This release shall neither constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which the offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.
Mr. Frederic Scheer, CEO
Dr. Alexandre Scheer, Chief Medical Officer
Tel: (406) 233-6434