LexaGene Completes Analytical Studies for FDA EUA of COVID-19 Testing
LexaGene Completes Analytical Studies for FDA EUA of COVID-19 Testing
BEVERLY, Mass., Oct. 25, 2021 (GLOBE NEWSWIRE) -- LexaGene Holdings, Inc., (OTCQB: LXXGF; TSX-V: LXG) ("LexaGene" or the "Company"), a molecular diagnostics company that has commercialized an instrument for automated multiplex PCR testing for veterinary diagnostics and biopharmaceutical manufacturing, today announced it has completed its analytical studies required by the FDA for an Emergency Use Authorization (EUA) application for COVID-19 diagnostics.
馬薩諸塞州貝弗利，2021年10月25日(Global Newswire)--分子診斷公司LexaGene Holdings，Inc.(OTCQB：LXXGF；TSX-V：LXG)(“LexaGene”或“公司”)今天宣佈，它已經完成了FDA要求的分析研究，以申請緊急使用授權(EUA)。該公司已經將一種用於獸醫診斷和生物製藥製造的自動多重PCR檢測儀器商業化。
LexaGene is in the process of completing the necessary work to have the FDA rule on authorizing the MiQLab™ for COVID-19 testing. The FDA is expected to classify the MiQLab as a class II medical device. As such, the process of preparing its point-of-care (POC) fully-automated PCR system, which is comprised of hardware, firmware, software, and chemistry, for evaluation by the FDA, is considerably more complex than if it were simply submitting only a COVID-19 PCR test chemistry for FDA authorization.
利華基因正在完成必要的工作，以使美國食品和藥物管理局制定規則，授權米高梅實驗室的™進行新冠肺炎測試。預計FDA將把MiQLab歸類為II類醫療設備。因此，準備其由硬件、固件、軟件和化學物質組成的護理點全自動聚合酶鏈式反應系統(由硬件、固件、軟件和化學物質組成)供美國食品和藥物管理局進行評估的過程比簡單地將新冠肺炎聚合酶鏈反應檢測化學物質提交美國食品和藥物管理局授權的過程要複雜得多。
Dr. Jack Regan, LexaGene's CEO and Founder stated, "Successfully completing these studies is a big step for LexaGene, as these data could only be collected after we have sufficiently met a number of requirements for system/software verification, electrical safety testing, manufacturing process qualification, quality control, and the associated documentation. It is our belief that the quality of our data will meet FDA expectations. Our next step is to have a third party conduct a COVID-19 clinical evaluation using the MiQLab System at both a POC testing facility and a clinical laboratory, and then the analytical and clinical data will be compiled and submitted to the FDA for authorization."
利盟基因首席執行官兼創始人傑克·里根博士表示：“成功完成這些研究對利盟基因來説是一大進步，因為只有在我們充分滿足了系統/軟件驗證、電氣安全測試、製造過程資格、質量控制和相關文件等方面的一系列要求之後，才能收集這些數據。我們相信，我們的數據質量將達到食品和藥物管理局的預期。我們的下一步是讓第三方在POC檢測機構和臨牀實驗室使用MiQLab系統進行一次新冠肺炎臨牀評估，然後進行分析。我們的下一步是讓第三方在POC檢測機構和臨牀實驗室使用MiQLab系統進行LexaGene臨牀評估，然後進行分析
The following analytical studies were completed using multiple MiQLab Systems:
使用多個MiQLab系統完成了以下分析研究：
- External Quality Control Validation
- Analytical Sensitivity: Limit of Detection (LoD)
- Analytical Specificity: Cross-Reactivity
- Endogenous Interference Substances Studies
- Carry-over/Cross-Contamination Study
- Sample Stability
- 外部質量控制驗證
- 分析靈敏度：檢出限(LOD)
- 分析特異性：交叉反應性
- 內源性干擾物質研究進展
- 結轉/交叉污染研究
- 樣品穩定性
Dr. Regan continued, "This milestone should be viewed as having much broader implications than COVID-19 testing only. Our goal is to get our technology through the FDA so that we can leverage the system's high-quality sample preparation followed by broad-multiplex PCR analysis, which is a combination of features that many currently authorized COVID-19 only testing devices do not have. These features make the MiQLab ideally suited for syndromic testing of complex diseases that can be caused by 10 or more pathogens, such as respiratory diseases (e.g., COVID-19, influenza A & B, RSV, adenovirus, metapneumovirus, etc.), gastro-intestinal diseases, urinary tract diseases, and skin and soft tissue diseases. Preparing our technology to be able to successfully collect the analytical COVID-19 data is arguably the hardest step in the EUA process. If we are successful in being authorized for COVID-19 testing, we will follow this work with studies to support 510(k) applications for complex diseases in human clinical medicine."
里根博士繼續説：“這一里程碑應該被視為具有比僅僅新冠肺炎檢測更廣泛的意義。我們的目標是讓我們的技術通過食品和藥物管理局，這樣我們就可以利用系統的高質量樣品準備和寬複用聚合酶鏈反應分析，這是許多目前授權的新冠肺炎專用檢測設備所不具備的功能的組合。這些特點使得MiQLab非常適合由10種或10種以上病原體引起的複雜疾病的症狀測試，例如呼吸系統疾病(例如新冠肺炎、甲型和乙型流感、呼吸道合胞病毒、腺病毒、偏肺病毒等)、胃腸道疾病、泌尿系疾病以及皮膚和軟組織疾病。準備我們的技術以便能夠成功收集新冠肺炎分析數據可以説是歐盟評估過程中最困難的一步。如果我們成功獲得新冠肺炎測試的授權，我們將緊隨這項工作進行研究，以支持人類臨牀醫學中複雜疾病的510(K)應用。“
LexaGene's MiQLab system is unique in that it is a flow-through PCR system. To LexaGene's knowledge, the FDA has never received an application for a flow-through PCR system for use in human clinical diagnostics. It is possible the FDA will require additional studies prior to passing final judgement. Once the required studies are complete, there is no guarantee the FDA will deem the data to be satisfactory for authorization of the system for human clinical diagnostics. Prior to the FDA's ruling, all data and communications with the FDA are deemed private. Until the FDA grants LexaGene's system EUA for COVID-19 testing, all work using LexaGene instruments is classified as Research Use Only and cannot be used for human clinical diagnostics.
LexaGene的MiQLab系統的獨特之處在於它是一個流通式PCR系統。據LexaGene所知，FDA從未收到用於人類臨牀診斷的直通式PCR系統的申請。在做出最終判斷之前，FDA可能會要求進行更多的研究。一旦完成了所需的研究，不能保證FDA會認為這些數據是令人滿意的，可以授權該系統用於人類臨牀診斷。在FDA做出裁決之前，與FDA的所有數據和通信都被認為是私人的。在食品和藥物管理局批准利華基因公司的系統用於新冠肺炎測試之前，所有使用利華基因儀器的工作都被歸類為僅用於研究，不能用於人類臨牀診斷。
An interview with Dr. Regan can be viewed HERE.
在這裏可以看到對里根博士的採訪。
To learn more about LexaGene and the MiQLab System or subscribe to company updates, visit www.lexagene.com, or follow us on Twitter or LinkedIn.
要了解有關LexaGene和MiQLab系統的更多信息或訂閲公司更新，請訪問www.lexagene.com，或在Twitter或LinkedIn上關注我們。
On Behalf of the Board of Directors
Dr. Jack Regan
Chief Executive Officer & Chairman
我謹代表董事會傑克·里根博士首席執行官兼董事長
About LexaGene Holdings Inc.
LexaGene is a molecular diagnostics company that develops molecular diagnostic systems for pathogen detection and genetic testing for other molecular markers for on-site rapid testing in veterinary diagnostics, food safety and for use in open-access markets such as clinical research, agricultural testing, and biodefense. End-users simply need to collect a sample, load it onto the instrument with a sample preparation cartridge, enter sample ID and press 'go'. The MiQLab™ system delivers excellent sensitivity, specificity, and breadth of detection and can return results in approximately two hours. The unique open-access feature is designed for custom testing so that end-users can load their own real-time PCR assays onto the instrument to target any genetic target of interest.
關於LexaGene控股公司LexaGene是一家分子診斷公司，為病原體檢測和其他分子標記的基因檢測開發分子診斷系統，用於獸醫診斷、食品安全的現場快速測試，並用於臨牀研究、農業檢測和生物防禦等開放市場。最終用户只需採集樣本，用樣本製備盒將其裝載到儀器上，輸入樣本ID，然後按“GO”。MiQLab™系統具有出色的靈敏度、特異度和檢測廣度，可在大約兩小時內返回結果。獨特的開放存取功能是為定製測試而設計的，這樣終端用户就可以將他們自己的實時PCR分析加載到儀器上，以瞄準任何感興趣的基因目標。
The TSX Venture Exchange Inc. has in no way passed upon the merits of the proposed transaction and has neither approved nor disapproved the contents of this press release. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
多倫多證券交易所創業板交易所公司沒有以任何方式忽略擬議交易的優點，也沒有批准或不批准本新聞稿的內容。多倫多證券交易所創業板交易所及其監管服務提供商(該術語在多倫多證券交易所創業板政策中定義)均不對本新聞稿的充分性或準確性承擔責任。
This news release contains forward-looking information, which involves known and unknown risks, uncertainties and other factors that may cause actual events to differ materially from current expectation. Important factors -- including the availability of funds, the results of financing efforts, the success of technology development efforts, the cost to procure critical parts, performance of the instrument, market acceptance of the technology, regulatory acceptance, and licensing issues -- that could cause actual results to differ materially from the Company's expectations as disclosed in the Company's documents filed from time to time on SEDAR (see www.sedar.com). Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The company disclaims any intention or obligation, except to the extent required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
本新聞稿包含前瞻性信息，涉及已知和未知的風險、不確定性和其他可能導致實際事件與當前預期大不相同的因素。重要因素--包括資金的可獲得性、融資努力的結果、技術開發努力的成功、採購關鍵部件的成本、儀器的性能、市場對技術的接受程度、監管接受程度以及許可問題--可能導致實際結果與公司不時提交給SEDAR的文件中披露的預期大不相同(參見Www.sedar.com)。告誡讀者不要過度依賴這些前瞻性陳述，這些陳述僅在本新聞稿發佈之日發表。除法律要求的範圍外，該公司沒有任何意圖或義務來更新或修改任何前瞻性陳述，無論是由於新信息、未來事件或其他原因。
CONTACT: Corporate & Media Contact: Gail Winslow Director of Marketing gwinslow@lexagene.com 978.482.6237 ir@lexagene.com 800.215.1824 Investors: Sharon Choe Vice President LaVoieHealthScience schoe@lavoiehealthscience.com (857) 241-7393
聯繫人：公司和媒體聯繫人：營銷總監蓋爾·温斯洛gwinlow@lexagene.com 978.482.6237 ir@lexagene.com 800.215.1824投資者：Sharon Choe副總裁LaVoieHealthScience Schoe@lavoieHealth cience.com電話：(857)241-7393
譯文內容由第三人軟體翻譯。