帝基生物DiaCarta猴痘检测试剂盒获美国食品药品监督管理局（FDA）紧急使用授权（EUA）

2023-01-13 09:00 · 生物探索

美国加州—精准分子诊断公司DiaCarta，帝基今日(2023-1-12)宣布美国美国食品药品监督管理局（FDA）授予其猴痘病毒检测试剂盒紧急使用授权。生物试剂食品使用授权

美国加州—精准分子诊断公司DiaCarta（帝基生物），猴痘盒获今日(2023-1-12)宣布美国美国食品药品监督管理局（FDA）授予其猴痘病毒检测试剂盒（QuantiVirusTM MPXV test kit）紧急使用授权（Emergency Use Authorization，检测监督局F紧急EUA），美国该检测试剂盒可用于Thermo Fisher（ABI）QuantStudio5、药品Thermo Fisher（ABI）7500 Fast Dx、管理Bio-Rad CFX384或Roche LightCycler 480 II Systems等qPCR设备。帝基 QuantiVirusTM MPXV是生物试剂食品使用授权一种定量PCR检测试剂盒，用于精准检测疑似猴痘感染者样本中猴痘病毒（MPXV）DNA。猴痘盒获

QuantiVirusTM MPXV检测遵循美国疾病控制与预防中心（CDC）指导，检测监督局F紧急利用公司特有的美国技术针对MPXV基因组两个不同目标区域进行检测。相比MPXV基因组的药品其他部分，这两个区域不易发生突变。管理即使其中一个目标区域发生突变，帝基这种双靶标方法也能够确保QuantiVirusTM MPXV将继续进行精准检测。

“很高兴看到我们团队能快速为市场推出猴痘病毒检测产品并得到FDA的认可，又一次把我们推到抗击疫情的前沿阵地，为阻击潜在的猴痘病毒扩散做贡献。” 帝基生物DiaCarta 总裁 张爱国博士（Adam Zhang）表示。在最初报告猴痘病毒感染病例时，帝基生物DiaCarta总部即迅速调动、分配资源，充分利用公司的专利技术开发检测试剂盒，用以解决猴痘病毒问题。为了满足测试需求，实现简单的工作流程以及提供安全可靠的测试解决方案，公司基于高通量开放qPCR系统开发出QuantiVirusTM MPXV检测试剂盒。

开放式qPCR系统的高通量解决方案可以帮助实验室轻松简便进行测试，并帮助被检人员快速获得正确结果。这对于患者尽快获得适当的治疗非常重要，似猴患者也无需接受不必要的额外检测或进行隔离。

关于猴痘 （MPXV）

猴痘的常见症状包括发烧、寒战、头痛、肌肉酸痛、疲劳、淋巴结肿胀和皮疹。皮疹的典型特征表现为皮肤上凸起肿块，并多分布在面部、四肢和生殖器等部位。随着疾病的发展，这些肿块内将充满脓液，形成脐状。最终发生溃疡，然后结痂脱落。

关于帝基生物（Diacarta）

帝基生物科技有限公司（DiaCarta）是一家精准分子诊断公司，公司开发出创新性技术，通过使用液体活检提供有效的精确诊断来改变患者护理。除了FDA/EUA批准的QuantiVirusTM SARS-CoV-2检测试剂盒外，帝基生物还提供包括QClamp qPCR、OptiSeqTM XNA-NGS Panel等其他一系列检测服务。公司新型XNA分子嵌合技术因其能够钳住野生型序列，放大突变目标序列，而具备高水平灵敏度。基于新型XNA分子嵌合技术，帝基生物开发出基于血液样本的高灵敏度ColoScapeTM结直肠癌早期检测试剂盒。帝基生物高水平信号放大技术——SuperbDNATM技术，可实现核酸高水平定量检测，无需RNA/DNA提取，也无需PCR扩增。基于SuperbDNATM技术，帝基生物开发出的RadToxTM测试，可个性化放疗或化疗、肿瘤反应并加强患者护理。公司总部位于加利福尼亚州普莱森顿，并获得ISO认证，符合GMP标准，并为客户提供CLIA认证的实验室服务。

On October 14, 2022, DiaCarta and HH&L Acquisition Co. (NYSE: HHLA), a special purpose acquisition corporation, entered into a definitive business combination agreement that would result in DiaCarta becoming a public company.

Important Additional Information Will Be Filed with the SEC

This communication relates to the proposed business combination between HH&L and DiaCarta (the “Business Combination”). HH&L has filed a preliminary, and will file a definitive, proxy statement, which will include a prospectus, which will be a part of a registration statement, and other relevant documents with the SEC. This communication does not contain all the information that should be considered concerning the proposed Business Combination and is not intended to form the basis of any investment decision or any other decision in respect of the Business Combination. HH&L’s and DiaCarta’s shareholders and other interested persons are urged to read the proxy statement/prospectus and any other relevant documents filed with the SEC when they become available, and any amendments thereto, because, among other things, they will contain updates to the financial, industry and other information herein as well as important information about HH&L, DiaCarta and the contemplated Business Combination. When available, the definitive proxy statement/prospectus and other relevant materials for the proposed Business Combination will be mailed to shareholders of HH&L as of a record date to be established for voting on the proposed Business Combination. Shareholders will be able to obtain a free copy of the proxy statement/prospectus (when filed), as well as other filings containing information about HH&L, DiaCarta and the proposed Business Combination, without charge, at the SEC’s website located at www.sec.gov or by directing a request to: HH&L Acquisition Co., Suite 2001-2002, 20/F, York House, The Landmark, 15 Queen’s Road Central, Central, Hong Kong. Investment in any securities described herein has not been approved or disapproved by the SEC or any other regulatory authority nor has any authority passed upon or endorsed the merits of the Business Combination or the accuracy or adequacy of the information contained herein. Any representation to the contrary is a criminal offense.

Forward-Looking Statements

This communication contains certain statements, estimates, targets, forecasts, and projections with respect to HH&L or DiaCarta. All statements other than statements of historical fact are forward-looking statements. Forward-looking statements include, without limitation, statements regarding the estimated future financial performance and financial position of DiaCarta. Future results are not possible to predict. Opinions and estimates offered in this communication constitute DiaCarta’s judgment and are subject to change without notice, as are statements about market trends, which are based on current market conditions. You can identify these forward looking statements through the use of words such as “may,” “will,” “can,” “anticipate,” “assume,” “should,” “indicate,” “would,” “believe,” “contemplate,” “expect,” “seek,” “estimate,” “continue,” “plan,” “point to,” “project,” “predict,” “could,” “intend,” “target,” “potential” and other similar words and expressions of the future, but the absence of these words does not necessarily mean that a statement is not forward-looking. Such forward-looking statements are based on estimates, assumptions and factors that are inherently uncertain, that are beyond DiaCarta’s control or ability to predict and that could cause actual results to differ materially from expected results. As a result, they are subject to significant risks and uncertainties and actual events or results may differ materially from these forward-looking statements. No reliance should be placed on, any forward-looking statements, including any projections, targets, estimates or forecasts contained in this communication. Any forward-looking statement speaks only as of the date on which it was made, based on information available as of the date of this communication, and such information may be inaccurate or incomplete. Products described by DiaCarta in its pipeline are under investigation and have not been proven to be safe or effective, and there is no guarantee any such product will be approved in the sought-after indication or will meet the developmental milestones set forth herein, including within the timeline set forth herein. Neither DiaCarta, nor HH&L undertakes any obligation to release any revisions to such forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Information regarding performance by, or businesses associated with, our management team or businesses associated with them is presented for informational purposes only. Past performance by DiaCarta’s management team and its affiliates is not a guarantee of future performance. Therefore, you should not rely on the historical record of the performance of DiaCarta’s management team or businesses associated with them as indicative of DiaCarta’s future performance of an investment or the returns DiaCarta will, or is likely to, generate going forward.

Participants in the Solicitation

HH&L and its directors and executive officers may be deemed to be participants in the solicitation of proxies from HH&L’s shareholders in connection with the proposed Business Combination. A list of the names of HH&L’s directors and executive officers and information regarding their interests in HH&L is contained in HH&L’s Annual Report on Form 10-K, which was filed with the SEC on March 30, 2022, and is available free of charge at the SEC’s website at www.sec.gov, or by directing a request to HH&L Acquisition Co., Suite 2001-2002, 20/F, York House, The Landmark, 15 Queen’s Road Central, Central, Hong Kong. Additional information regarding the interests of any such participants will be contained in the proxy statement/prospectus for the proposed Business Combination when available.

DiaCarta and its directors and executive officers may also be deemed to be participants in the solicitation of proxies from the shareholders of HH&L in connection with the proposed Business Combination. A list of the names of such directors and executive officers and information regarding their interests in the proposed Business Combination will be included in the proxy statement/prospectus for the proposed Business Combination when available.

The definitive proxy statement/prospectus will be mailed to shareholders as of a record date to be established for voting on the proposed Business Combination when it becomes available. Shareholders, potential investors and other interested persons should read the proxy statement/prospectus carefully when in becomes available before making any voting or investment decisions.

No Offer or Solicitation

This communication is for informational purposes only and does not constitute (i) a solicitation of a proxy, consent or authorization with respect to any securities or in respect of the Business Combination, (ii) an offer or invitation for the sale or purchase of the securities, assets or business described herein or a commitment of HH&L, DiaCarta or any of their respective subsidiaries, stockholders, affiliates, representatives, partners, directors, officers, employees, advisers or agents, with respect to any of the foregoing, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction, and this press release shall not form the basis of any contract, commitment or investment decision and does not constitute either advice or recommendation regarding any securities.

Company Contact:

Anne Vallerga PhD, MBA

VP, External Affairs

annek@diacarta.com

PR Contact:

Jennifer Sparano

VP, Public Relations

jsparano@peregrinemarketaccess.com

Investor Contact:

Cody Slach, Matthew Hausch

Gateway Investor Relations

(949) 574-3860

DiaCarta@GatewayIR.com