据Magigen IVD行业新闻消息,分子诊断公司Anavasi Diagnostics周二宣布,它已收到美国国立卫生研究院NIH快速加速诊断计划RADx(Rapid Acceleration of Diagnostics initiative)的1490万美元,用于将其IVD体外诊断产品-快速分子新冠病毒检测产品商业化。
AnavasiDiagnosticszhōu周èr二xuān宣bù布,tā它yǐ已shōu收dào到měi美guó国guó国lì立wèi卫shēng生yán研jiū究yuàn院kuài快sù速jiā加sù速zhěn诊duàn断jì计huà划(RapidAccelerationofDiagnosticsinitiative)de的1490wàn万měi美yuán元,yòng用yú于jiāng将qí其kuài快sù速fèn分zǐ子xīn新guàn冠bìng病dú毒-19jiǎn检cè测shāng商yè业huà化。
The RADx funding will be used to accelerate the launch and market availability of the AscencioDx test, Anavasi said in a statement. Namely, it will be used to hire additional production staff, acquire improved manufacturing automation equipment, and further develop the company's portal for healthcare reporting. The portal is sponsored by the US Department of Health and Human Services, Anavasi said.
Anavasi在一份声明中表示,RADx资金将用于加速AscencioDx IVD检测产品的推出和市场化推广。它将用于雇佣更多的生产人员,购买改进的制造自动化设备,并进一步开发公司的医疗报告门户网站。该公司的门户网站由美国卫生和公共服务部赞助,具备云功能。
Anavasizài在yī一fèn份shēng声míng明zhōng中biǎo表shì示,RADxzī资jīn金jiāng将yòng用yú于jiā加sù速AscencioDxcè测shì试de的tuī推chū出hé和shì市chǎng场kě可yòng用xìng性。yě也jiù就shì是shuō说,tā它jiāng将yòng用yú于gù雇yōng佣gèng更duō多de的shēng生chǎn产rén人yuán员,gòu购mǎi买gǎi改jìn进de的zhì制zào造zì自dòng动huà化shè设bèi备,bìng并jìn进yī一bù步kāi开fā发gōng公sī司de的yī医liáo疗bào报gào告mén门hù户。Anavasishuì说,gāi该mén门hù户wǎng网zhàn站yóu由měi美guó国wèi卫shēng生hé和gōng公gòng共fú服wù务bù部zàn赞zhù助。
The test uses loop-mediated isothermal amplification to detect SARS-CoV-2 from nasal swabs in approximately 30 minutes. The assay's detector can be used for at least 3,000 single-use tests and the price will be comparable to antigen tests, the Woodinville, Washington-based company said.
该公司的IVD体外诊断检测产品使用环介导等温扩增技术-LAMP扩增技术,可以在大约30分钟内,从鼻拭子中检测新冠病毒COVID19。该检测方法的检测器可用于至少3000次一次性检测,价格将与抗原检测相当。
gāi该shì试yàn验shǐ使yòng用huán环jiè介dǎo导děng等wēn温kuò扩zēng增jì技shù术,zài在dà大yuē约30fēn分zhōng钟nèi内cóng从bí鼻shì拭zǐ子zhōng中jiǎn检cè测SARS-CoV-2。zǒng总bù部wèi位yú于huá华shèng盛dùn顿de的Woodinvillegōng公sī司biǎo表shì示,gāi该jiǎn检cè测fāng方fǎ法de的jiǎn检cè测qì器kě可yòng用yú于zhì至shǎo少3000cì次yī一cì次xìng性jiǎn检cè测,jià价gé格jiāng将yǔ与kàng抗yuán原jiǎn检cè测xiāng相dāng当。
The AscencioDx test is currently in clinical trials and Anavasi plans to submit the test to the US Food and Drug Administration for Emergency Use Authorization "in the near future," the company said.
AscencioDx检测产品目前正在临床试验中,Anavasi计划很快可以将该试验提交给美国食品和药物管理局FDA,以获得紧急使用授权EUA,争取市场优势。
AscencioDxshì试yàn验mù目qián前zhèng正zài在lín临chuáng床shì试yàn验zhōng中,Anavasijì计huà划“zài在bù不jiǔ久de的jiāng将lái来”jiāng将gāi该shì试yàn验tí提jiāo交gěi给měi美guó国shí食pǐn品hé和yào药wù物guǎn管lǐ理jú局,yǐ以huò获dé得jǐn紧jí急shǐ使yòng用shòu授quán权。
The initial submission will be for use by a medical professional at the point of care, including at physicians' offices, emergency rooms, urgent care centers, mobile testing sites, universities, and workplaces. However, the company said the test has potential for at-home use.
该公司最初提交的申请是针对专业应用,供医疗专业人员在医疗点使用,包括医生诊所、急诊室、紧急护理中心、移动检测点、大学和工作场所。该公司表示,下一步该检测产品将推广至有在家使用。

AscencioDx产品
zuì最chū初tí提jiāo交de的bào报gào告jiāng将gōng供yī医liáo疗zhuān专yè业rén人yuán员zài在yī医liáo疗diǎn点shǐ使yòng用,bāo包kuò括yī医shēng生bàn办gōng公shì室、jí急zhěn诊shì室、jǐn紧jí急hù护lǐ理zhōng中xīn心、yí移dòng动jiǎn检cè测diǎn点、dà大xué学hé和gōng工zuò作chǎng场suǒ所。rán然ér而,gāi该gōng公sī司biǎo表shì示,gāi该cè测shì试jù具yǒu有zài在jiā家shǐ使yòng用de的qián潜lì力。
Anavasi previously received $250,000 in NIH funding last year to pivot its business from HIV to COVID-19 detection. It has raised $2.6 million in funding to date, and recently closed a $6 million convertible promissary note round, a spokesperson for the company said.
Anavasi去年曾获得美国国家卫生研究院25万美元的资助,将其业务从HIV转为新冠病毒检测。迄今为止,该公司已筹集260万美元资金,最近完成了一轮600万美元的可转换交易。
Anavasiqù去nián年céng曾huò获dé得měi美guó国guó国jiā家wèi卫shēng生yán研jiū究yuàn院25wàn万měi美yuán元de的zī资zhù助,jiāng将qí其yè业wù务cóng从HIVzhuǎn转wéi为xīn新guàn冠bìng病dú毒jiǎn检cè测。gāi该gōng公sī司yī一wèi位fā发yán言rén人biǎo表shì示,qì迄jīn今wéi为zhǐ止,gāi该gōng公sī司yǐ已chóu筹jí集260wàn万měi美yuán元zī资jīn金,zuì最jìn近wán完chéng成le了yī一lún轮600wàn万měi美yuán元de的kě可zhuǎn转huàn换běn本piào票jiāo交yì易。
The platform, developed at the University of Washington, could also be used for other viruses. "Its origins detecting HIV variants make it ideal for the additional detection of other viruses such as influenza A and/or B, as well as respiratory syncytial virus," Anavasi CEO Nelson Patterson said in a statement.
该检测技术平台由华盛顿大学开发,也可以用于其他病毒。Anavasi首席执行官帕特森在一份声明中说:“它的起源是检测HIV变异,这使得它非常适合于检测其他病毒,如甲型流感和/或乙型流感,以及呼吸道合胞病毒。未来的产品将包括多重呼吸道疾病测试。“
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