XPhyto Therapeutics (XPHY.C) has delivered 2,000 of its rapid, 25-minute polymerase chain reaction (PCR) tests, COVID-ID Lab, to an established medical distributor in Israel for clinical evaluation for the purpose of commercial regulatory approval and potential distribution.
“We are excited by the opportunity to expand potential distribution beyond Germany. We are building strong partnerships around the world, and Israel is a leading nation for COVID-19 management and research…We expect that rapid and accurate diagnostic testing will remain a primary tool for pandemic management and monitoring for many years to come,” said Hugh Rogers, chief executive officer and director of Xphyto.
COVID-ID Lab is XPhyto’s multiplex viral ribonucleic acid (RNA) probe kit based on the reverse transcriptase-polymerase chain reaction (RT-PCR) method. Translated into slightly more palatable terms, the Company’s COVID-ID Lab required a single 20-minute PCR thermal cycle without RNA extraction as part of the sample preparation. Once the PCR cycle is completed, a 5-minute detection process occurs, totaling 25 minutes to complete the test. The exclusion of RNA extraction for sample preparation reduces the risk of cross-contamination and minimizes the need for lab equipment and trained personnel. A combination of rapid results, minimal material and ease of use could result in reduced operations costs and portability.
So, COVID-ID Lab is essentially a highly convenient, streamlined and accessible COVID-19 testing kit? Bingo. Additionally, the test itself is highly sensitive, reaching a 95% confidence interval. XPhyto recently received approval of COVID-ID Lab based on the European in vitro diagnostic (CE IVD) ON March 18, 2021. The Company’s COVID-ID Lab tests will now to evaluated by the Israeli Ministry of Health (AMAR) with the intent of securing Israeli regulatory approval. As previously mentioned, this could potentially open the doors for distribution of COVID-ID Lab is Israel. As such, XPhyto is already in contact with potential customers, partners and licensees.
However, according to Rachel Schraer, BBC’s health reporter, Israel may be close to achieving herd immunity. Herd immunity occurs when a certain percentage of a population has protection against an infection, preventing it from spreading further. This indirectly protects the remaining percentage of the population that does not have protection via vaccines or other preventative measures. More than 50% of Israel’s residents have been vaccinated and an additional 830,000 have already tested positive for the virus in the past, potentially providing natural immunity. In total, an estimated 68% of Israel’s population are likely to have antibodies capable of fighting the virus. With this in mind, how useful will XPhyto’s COVID-ID Lab tests be in Israel? Despite reduced restrictions, cases of COVID-19 in Israel continue to fall.
The clinical evaluation process is expected to be completed in less than 90 days and will serve as the basis for commercial approval of COVID-ID Labs in the country. How COVID-ID Lab will perform in the Israeli market will likely come down to the details of its commercialization and the various agreements XPhyto can establish. Leading up to the approval of COVID-ID Lab in Israel, XPhyto may be worth keeping an eye on.
XPhyto’s share price opened at $2.58, up from a previous close of $2.41. The Company’s shares are currently trading at $2.46 indicating that there has been some change following the news.
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