NEW YORK – Following de novo clearance this month of its combination influenza and COVID-19 lateral flow test for over-the-counter use, Houston-based Healgen Scientific expects to scale up manufacturing in both the US and China to meet global demands during the current respiratory virus season.

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Healgen's Rapid Check COVID-19/Flu A&B Antigen Test detects influenza A, influenza B, and COVID-19 from anterior nasal swabs in approximately 15 minutes. Authorized for self-testing by people ages 14 years and older, the test can also be used on children as young as 2 years old.

Healgen的快速检查COVID-19/流感A＆B抗原测试在大约15分钟内从前鼻拭子中检测到甲型流感，乙型流感和COVID-19。该测试授权14岁及以上的人进行自我测试，也可用于2岁以下的儿童。

In announcing that the test received de novo clearance, the US Food and Drug Administration noted that Healgen's test was evaluated by the Independent Test Assessment Program (ITAP) of the National Institutes of Health's Rapid Acceleration of Diagnostics (RADx) Tech division. In the evaluation, the test correctly identified 99 percent of negative and 92 percent of positive SARS-CoV-2 samples, 99.9 percent of negative flu A and flu B samples, and 92.5 percent and 90.5 percent of positive flu A and flu B samples, respectively, according to the FDA.

美国食品和药物管理局宣布该测试获得了从头批准，并指出Healgen的测试是由美国国立卫生研究院快速加速诊断（RADx）技术部门的独立测试评估计划（ITAP）评估的。在评估中，根据FDA的数据，该测试正确识别了99%的阴性和92%的阳性SARS-CoV-2样本，99.9%的阴性甲型和乙型流感样本，以及92.5%和90.5%的阳性甲型和乙型流感样本。

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Because of 'the specificity and sensitivity that we were able to achieve, it is only recommended that an individual do a single test,' with Healgen's assay, Albert Berger, the company's VP of marketing, said in an interview, adding that this is a key differentiator of Healgen's OTC offering compared to most COVID antigen tests in the growing at-home testing space which require two serially administered tests taken a day or two apart for conclusive results.

该公司营销副总裁阿尔伯特·伯杰（AlbertBerger）在接受采访时表示，由于“我们能够实现的特异性和敏感性，因此只建议个人进行一次检测”，该公司的营销副总裁阿尔伯特·伯杰（AlbertBerger）在接受采访时表示，与不断增长的家庭检测领域中的大多数新型冠状病毒抗原检测相比，这是Healgen OTC产品的一个关键区别，因为大多数新型冠状病毒抗原检测需要间隔一两天进行两次连续检测才能得出结论性结果。

The high accuracy of Healgen's test is due to proprietary chemistry and manufacturing techniques, he noted. .

他指出，Healgen测试的高精度归功于专有的化学和制造技术。

As a de novo-cleared test, Healgen's combo assay will now serve as the predicate device for future 510(k) submissions from competing offerings. For more than a year, the FDA has been winding down the Emergency Use Authorization of COVID-19 tests, though that process has yet to completely wrap up, as the agency intends for all COVID tests to complete a full regulatory review process.

作为一项从头批准的测试，Healgen的组合分析现在将作为未来510（k）来自竞争产品提交的谓词设备。一年多来，美国食品和药物管理局一直在逐步取消新型冠状病毒检测的紧急使用授权，尽管该过程尚未完全结束，因为该机构打算让所有新型冠状病毒检测完成一个完整的监管审查过程。

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Competing offerings for future 510(k) flu/COVID combo tests could include any of 20 multi-analyte lateral flow tests for home use that have been granted EUA since 2021, or approximately 10 rapid combo tests that have been evaluated by RADx's ITAP.

未来510（k）流感/新型冠状病毒组合测试的竞争产品可能包括自2021年以来获得EUA批准的20种家用多分析物横向流动测试中的任何一种，或者由RADx的ITAP评估的大约10种快速组合测试。

The ITAP evaluation was coordinated by VentureWell under a contract awarded by the National Institute of Biomedical Imaging and Bioengineering. Tests are submitted by manufacturers responding to a solicitation whose primary place of business is in the US and who have technologies that can quickly scale production..

ITAP评估由VentureWell根据National Institute of Biomedical Imaging and Bioengineering授予的合同进行协调。测试由制造商提交，以响应主要营业地在美国且拥有可快速规模生产技术的招标。。

While Healgen's test isn't first to market — EUA OTC tests are still on the shelves — it does have the advantage of being fully cleared and rigorously evaluated by a reputable source. It may also have advantages in terms of manufacturing volumes and in having a US manufacturing facility.

虽然Healgen的测试并不是第一个上市的测试-EUA OTC测试仍在货架上-但它确实具有被信誉良好的来源完全清除和严格评估的优势。它在制造量和拥有美国制造工厂方面也可能具有优势。

Founded in Houston by Bingliang Fang and his brother Bryan in 2007, Healgen is a wholly owned subsidiary of Anju, China-based Zhejiang Orient Gene Biotech, a publicly traded company that develops, manufactures, and sells in vitro diagnostic products. According to the firm, its main products are point-of-care diagnostic reagents, mainly for drug screening.

2007年，方炳良（Bingliang Fang）和他的兄弟布莱恩（Bryan）在休斯顿成立了希尔根（Healgen），是总部位于中国安居（Anju）的浙江东方基因生物技术（Zhejiang Orient Gene Biotech）的全资子公司，该公司是一家开发、制造和销售体外诊断产品的上市公司。据该公司称，其主要产品是即时诊断试剂，主要用于药物筛查。

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Healgen obtained EUA for a COVID test in June 2020, which was initially distributed by Confirm BioSciences and Menarini Silicon Biosystems. Healgen also worked with Siemens Healthcare Diagnostics to develop a rapid antigen self-test under the Clinitest brand.

。Healgen还与西门子医疗诊断公司合作，开发了Clinitest品牌下的快速抗原自检。

Healgen has distributed more than 400 million of its Rapid COVID-19 Antigen Self-Test Kits in the US to date, Berger said, and more than 2 billion test kits in 80 countries globally.

伯杰说，迄今为止，Healgen已在美国分发了4亿多份快速新型冠状病毒19抗原自检试剂盒，并在全球80个国家分发了20多亿份检测试剂盒。

Still, 'the lion's share of our revenues come out of China,' Berger said, adding, 'we have excellent relationships in the country, being based there, that allow us to get the raw materials that we need and want.'

伯杰说，尽管如此，“我们收入的大部分来自中国”，他补充说，“我们在中国有着良好的关系，总部设在那里，这使我们能够获得我们需要和想要的原材料。”

In May, Healgen obtained 510(k) for a COVID-19 test, followed by EUA for the combo test with a serial testing indication in June. When the firm cut the ribbon on a combined headquarters and manufacturing facility in Houston in August, it was already aiming to manufacture the OTC combo flu/COVID tests there..

5月，Healgen获得了510（k）的COVID-19测试，随后在6月获得了EUA的组合测试和一系列测试指示。当该公司于8月在休斯顿的总部和生产设施合并时，它已经打算在那里生产OTC流感/新型冠状病毒联合检测。。

'Some of the larger US tenders that we're pursuing require a 'Made in the USA' product in order to qualify,' Berger explained, adding that some US customers are also willing to absorb a price differential for such a seal.

伯杰解释说，我们正在进行的一些较大的美国招标要求“美国制造”产品才能获得资格，并补充说，一些美国客户也愿意接受这种印章的差价。

Healgen can also pivot test manufacturing to other lines of its parent company; Orient Gene has 325 global automated production lines with a daily production capacity of more than 22 million tests. During the pandemic, it also moved 15 production lines to the US and invested more than $100 million in large-scale manufacturing and warehouse facilities in New York, New Jersey, and Texas.

Healgen还可以将测试制造转向其母公司的其他生产线；Orient Gene拥有325条全球自动化生产线，日生产能力超过2200万次测试。。

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The Houston facility is expected to provide approximately 200 new jobs over the next three years, Healgen said in August, and it can produce roughly 500,000 tests per day. It is also slated to produce RSV tests in the near future, the firm added recently, and Berger suggested that RSV is a logical step for a future wave of OTC tests..

希尔根在8月份表示，休斯顿工厂预计在未来三年内将提供大约200个新工作岗位，每天可以生产大约500000个测试。该公司最近补充说，它还计划在不久的将来进行RSV测试，伯杰建议RSV是未来一波OTC测试的合理步骤。。

Meanwhile, Healgen has a menu of tests for infectious disease diagnosis — including a strep A test that was cleared in 2022 — as well as extant relationships with major US retailers that sell its drug testing kits, Berger said.

与此同时，伯杰说，Healgen拥有一系列传染病诊断测试菜单，包括2022年通过的链球菌a测试，以及与销售其药物测试套件的美国主要零售商的现有关系。

'We have hundreds of other tests currently in development,' both in Houston and in China, he noted, adding that Healgen and Orient Gene can quickly adapt these to meet changing global needs.

他指出，无论是在休斯顿还是在中国，我们目前都在开发数百种其他测试，他补充说，Healgen和Orient Gene可以快速调整这些测试以满足不断变化的全球需求。

The cost of the OTC combo test will be determined by retailers — Berger said Healgen does not provide a manufacturer's suggested retail price to its partners but rather lets them set their own price — and the company is now working diligently to secure combo test contracts with major retailers and with the US government.

OTC联合测试的成本将由零售商决定-伯杰说，Healgen不会向其合作伙伴提供制造商建议的零售价格，而是让他们自己定价-该公司目前正在努力与主要零售商和美国政府签订联合测试合同。

Healgen is also gauging demand and planning its manufacturing scale-up using end user algorithms and logistics..

Healgen还利用最终用户算法和物流来衡量需求并规划其制造规模。。

'We don't see any difficulties being able to keep up with demand,' Berger said, given dual manufacturing in the US and China.

伯杰说，考虑到美国和中国的双重制造，我们认为在满足需求方面没有任何困难。