Applied BioCode's U.S. operations chief, Chris Bernard, said that the U.S. government may make significant changes to the cap on the number of tests that can be performed at high targets. The goal is to increase shipments by 60% to 70%.
In addition, the company plans to launch two new RUO tests for Fungal and STI in the second half of next year, and will apply for 510K clearance from the US Food and Drug Administration (FDA) in 2024 when the STI is combined with the AMR.
According to Chris Bernard, demand for new coronary pneumonia tests in the U.S. market continues to decline and the U.S. government is considering a reduction in the coverage limit for high-target tests, a red flag for companies that lack the flexibility to apply for insurance coverage, which is an opportunity for Applied BioCode to grow rapidly. At this time, the company is adjusting its strategy to expand direct sales of in vitro diagnostic reagents (IVDs) on the one hand, and to expand its marketing and sales efforts more than in the past.
Idexx has completed the installation of 149 instruments in September this year and will continue to set up new laboratories in Australia next year. The company's sales will grow from RMB 4.77 million last year to RMB 20 million this year, with the potential to double to RMB 40 million next year.
The company is already in discussions with six major global test manufacturers to develop joint marketing programs. Through ongoing communication, the company will identify at least one partner in the US and one outside of the US as its primary partner, creating a more favourable marketing environment for the company's sales team through complementary product features and the high visibility of the other party. This will create a more favourable marketing environment for the company's sales team through complementary product features and the high profile of the other party.
In terms of new product development, we will focus on niche products with market differentiation and enter the market with the RUO version first and then proceed with the US FDA 510k application based on market feedback. In the coming year, we aim to launch two new RUO products, a fungal assay and a sexually transmitted disease assay.
The RUO version is capable of detecting up to 28 fungal targets at once, depending on patient symptoms. Magnetics has appointed the John Hopkins University Hospital team to develop the RUO version for application and marketing, and expects to enter the market in the second half of 2023.
STI for STIs is expected to be launched in the second half of 2023, followed by STI+AMR for STIs combined with drug resistance genes in the first half of 2024, both in the RUO format to be the first to market. The STI+AMR will be the first in the market to use a US FDA-approved platform for simultaneous testing of STIs and drug resistance genes to provide the right treatment.
In addition, the MDx3000 automated test system will be revised to enhance the competitiveness of the next generation of testing products. The MDx3000 is currently scheduled to be completed in the second half of 2024, targeting the two fast-growing molecular testing markets of urinary tract infection (UTI) and vaginitis.
In the first ten months of the year, the company's consolidated revenue reached a record high of $301 million, up 24.5% year-on-year, thanks to growth in sales of conventional IVD testing products and a steady flow of BMB orders from licensees. However, due to higher marketing and promotion expenses, accelerated development of new testing products and rising prices in the US, we still reported a cumulative loss of $1.83 per share in the first three quarters.
Looking ahead, the platform licensing business will see good order visibility following the expansion of commercial application development by Idexx, a major customer, and the completion of a new US$12 million contract with Applied BioCode. Both core businesses are developing positively and the Company is cautiously optimistic about its operations this year and next.
