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After Gaining CE-IVD for SARS-CoV-2 Test, Egoo Health Plans New Assays for POC Platform


NEW YORK – Egoo Health, a Danish diagnostics company, is moving ahead with plans to add two new CE-IVD marked tests to its menu in 2022, after obtaining regulatory compliance for its debut assay, a 30-minute, molecular point-of-care assay for SARS-CoV-2, earlier this year.

Jakob Broberg Lind, sales director at the firm, said the company has tests in its pipeline focused on C-reactive protein, a biomarker commonly used to measure inflammation, as well as phenylalanine, a marker linked to a rare inherited disorder. While he could not provide an exact date for achieving regulatory clearance, given the transition underway to a new regulatory framework in Europe covering in vitro diagnostics, he said Egoo expects it to happen in 2022.

Egoo Health has had a rather speedy debut on the European diagnostics market. The company was founded in 2019, and its corporate parent, called QLife Holding, went public last year and currently trades on the Nasdaq First North market in Stockholm. Most of Egoo's activities are based out of its office in Ballerup, a suburb of Copenhagen, Denmark, but QLife maintains its headquarters across the water in Helsingborg, Sweden.

Lind said that the company chose to officially incorporate in Sweden to have better access to Sweden's active private investment community, which is less risk averse compared to Denmark's conservative market. "In Denmark, you often have to be more advanced and fund your investment for many years with private investors before you [do an] IPO," commented Lind. "It's not easy to get started."

In contrast, QLife Holding was able to incorporate and launch Egoo Health, achieve ISO 13485 certification, obtain a CE-IVD mark for its first test, and raise SEK 55 million (about $6.3 million) via its IPO in a span of about two years. Earlier this year it also raised an additional SEK 15 million in loans to fund its activities and later carried out a directed share issue of approximately SEK 90 million during April. The company currently has 50 employees.

While it looks like a meteoric rise for a Scandinavian startup, the company's founders actually spent decades gathering experience in the IVD business and product development. CEO Thomas Warthoe, for instance, founded and successfully exited Display System Biotech, a Copenhagen-based company that offered tools for genomics research.

The Egoo Health System is currently the company's sole platform. It consists of its portable instrument, which weighs about 470 grams, as well as a clinical application and assay capsule. According to the developers, the system can detect biomarkers in blood, saliva, and urine, as well as from oropharyngeal swabs. Each assay capsule is single use and is designed to test one biomarker. Depending on the assay, the turnaround time can range from two to 30 minutes.

The different capsules will vary in price but Egoo's strategy is to be competitive with other conventional biomarker and PCR tests, while the instrument costs about as much as a new smartphone.

"This is very cheap," noted Lind. "For a company that manufactures devices in an ISO 13485-certified facility, selling clinical quality measurement devices at this price level is unheard of," Lind said. The Egoo system, which requires users to insert an assay capsule and close it for processing and analysis, resembles a single-serve coffee pod machine. Egoo's capsule-based test concept is "often compared with Nespresso's coffee concept," Lind said.

Once the system's plunger seals off an inserted capsule, the reaction begins, according to the firm. The Egoo Health System is capable of measuring fluorescence to measure DNA and RNA markers, enzymatic absorbance to measure lipids and creatinine, and to gauge immunoturbidimetric absorbance, for measuring levels of proteins of biological drugs.

Its extraction-free SARS-CoV-2 assay relies on isothermal reverse transcription strand invasion-based amplification, or RT-SIBA. In RT-SIBA, the RNA is transcribed to cDNA by a reverse transcriptase and then amplified and detected under isothermal reaction conditions, relying on a recombinase-coated single-stranded invasion oligonucleotide for the separation of a target duplex and leading to an exponential amplification. Egoo's capsules are processed using a specialized SIBA lysis-reaction buffer containing mild detergents, according to the company. Each test has a turnaround time of half an hour.

The company submitted a paper describing the assay to Nature Scientific Reports in July. In the preprint version, the authors reported an analytical sensitivity of 25 viral RNA copies per reaction, clinical sensitivity of between 87 and 98 percent, and clinical specificity of between 97 and 98 percent when compared to standard PCR assays.

According to Lind, the test has performed well since it was CE-IVD marked in January, with "very good traction in Sweden," Egoo's biggest market, where it has been adopted by companies that do rapid COVID-19 testing to provide travel certificates, for example. He noted that while such tests are free in Denmark, in Sweden individuals need to present with symptoms to obtain a free test, and that companies are using Egoo to process certificates quickly for travelers and others.

Lind said customers often have to choose between antigen tests, the utility of which he questioned, and PCR tests, which can take a day to produce a result. Having access to a platform that can offer "PCR-grade precision, and provide an answer within an hour" is attractive to them, said Lind. "People are willing to pay to avoid waiting 24 hours to get an answer."

In addition to uptake in Sweden, Egoo also secured some high profile customers this year. The company's platform was used to test people participating in the European Football Championship in Copenhagen, where the test was offered at a price of DKK 295 ($46) per person. The company similarly provided tests for the European Women's Handball Championship. Egoo is also engaging clinicians at nearby Hvidovre Hospital, who have been comparing its SARS-CoV-2 kit with a large panel of COVID-19 antigen tests on the market, as well as with PCR. Lind said the results of that comparison study are expected later this month. 

Two new tests

The two new tests in Egoo's pipeline are for C-reactive protein, or CRP, a biomarker that is used to detect the presence of inflammation or disease in the body. Elevated CRP can indicate cardiovascular diseases, infections, chronic inflammation, and some cancers. Lind acknowledged that CRP is a common test in the market used by general practitioners and hospitals everywhere, but that it is necessary for the firm to have a CRP assay available and that it, in a way, helps to introduce users to its technology. According to Lind, the CRP assay was actually first in line in the company's pipeline before the pandemic, and now work has continued on delivering it to market sometime in 2022.

Its other new assay, the capsule for phenylalanine, or PHE, is used to monitor people with phenylketonuria, a rare inherited disorder affecting about 450,000 people worldwide, according to one recent study in the American Journal of Human Genetics. Those with the disorder have a lack of enzymes for breaking down the amino acid phenylalanine, which can build up after eating protein or aspartame, and can lead to health problems. The treatment for the disorder is a lifelong change in diet. Having an at-home test available for PHE would allow patients with the disorder to monitor their PHE levels on a daily basis.

Lind said that Egoo has developed a method to test for the PHE marker in very small amounts of whole blood, which will make the technology underlying its PHE assay an avenue for developing and launching subsequent tests.

"Not only is there a big need within this specific group of people," noted Lind, "but by developing this test, we also make our platform more versatile," he said. "That is another reason we are doing this." Lind reiterated that both tests will be available sometime next year, perhaps as soon as the first quarter.

Egoo is also exploring other markets beyond Europe. He said that the Egoo system is currently being tested and validated on a noncommercial basis in the US, Japan, and some other countries. With regards to the US, he acknowledged its importance in the consumer market and said that Egoo has "initiated first steps getting there, but it will take some time getting approved and registered."