NG & Atomo's 5-Minute Blood hCG Test

In the United States and Europe alone, there are about 20 million hCG tests performed each year, mostly in the emergency department in women with abdominal pain or bleeding symptoms. For many years, healthcare providers had to make a difficult decision between the two imperfect options: laboratory testing, which takes 1-2 hours to produce a blood test result and urine rapid testing, which has a 20-40 minute turnaround for a urine test result.

 

Although urine tests are simple and easily available, they do have a number of problems in the clinic. Collecting samples can be challenging and time consuming, especially in a busy ED. More importantly, urine is not as sensitive as blood for hCG detection and too low or weak a sample often causes false negative results. This has led to the demand for a more accurate and faster testing solution that retains the accuracy of laboratory testing, but provides the convenience of point-of-care testing.

The NG-Test Blood Precision hCG test is designed to overcome these problems in an elegant way, but technologically sophisticated. It takes only 10µL of blood drawn from a finger tip to give results similar to laboratory tests within 5 minutes. The truly unique thing about this innovation is that it is a whole package design, meaning all necessary components are built into this one easy to use device.

 

Atomo Diagnostics' platform expertise has played a key role in this. They have an integrated blood collection and delivery mechanism, a built-in safety lancet, and a unique buffer delivery mechanism. This complete integration will minimise sample collection, blood transfer and buffer application errors, which are typical with conventional rapid diagnostic tests.

The NG-Test platform has been a great success in the market since its inception. Recent financial reports indicate that NG Biotech's blood pregnancy tests have "well over 5, close to 10% of the pregnancy market" in key European territories, such as Spain, Portugal and Italy. This entry into the market confirms that consumers are interested in more accurate and reliable detection methods for early pregnancy.

 

The partnership between NG Biotech and Atomo Diagnostics keeps on growing, with both companies looking into new avenues of expansion. In a recent conference call, Atomo Diagnostics' CEO John Kelly said they are anticipating to be able to “announce to the market in the coming months a number of partnering opportunities for that product to be launched through Atomo into markets in which NG isn't active”. This includes the potential expansion into the United Kingdom and eventually the United States with a platform they've already proven to be effective and efficient on in the United States (CLIA waiver).

The first launch of NG-Test platform was supposed to be rolled out across Europe in 2017, but it has since become several product iterations. Today's NG PRECISION+® is the newest generation of this technology and is now available to consumers through the pharmacy retail pharmacies. The product is now CE certified in the EU/UK, and is Australian TGA certified, and is awaiting FDA approval for the United States market.

 

A professional and consumer version are now available. The NG-Test® hCG Blood Precision preserves the original integrated design for clinical use, while the NG PRECISION+® offers laboratory quality testing to the home user. The two versions have the same fundamental technology but different packaging and distribution networks to accommodate user needs.

The global fertility and pregnancy rapid test kits market is an important and expanding industry, and it is estimated that the market size will be around $779.44 million in 2026 and will reach at $1.14 billion by 2035 with a CAGR of 4.28%. Of this market, pregnancy detection makes up around 60% of sales and fertility testing makes up another 40% .

 

The hCG rapid test market is expected to grow by 7.35% CAGR from 2026 to 2035, reaching $5.32 billion by the end of the forecasted period. This growth is fuelled by global rising fertility awareness, higher incidence of conditions that necessitate early pregnancy diagnosis (including ectopic pregnancies) and greater availability of over-the-counter diagnostic products in emerging economies.

A significant and promising area in this market is blood-based pregnancy tests. The global HCG blood test pregnancy test market is anticipated to increase at 4.59% CAGR from 2025 and is expected to grow to $1.13 billion by 2033. North America accounts for 35-40% of the market with Europe at around 30%, with Asia-Pacific region being the fastest-growing region.

NG Biotech and Atomo Diagnostics are both continuing to innovate beyond pregnancy testing. In its growing diagnostic pipeline, NG Biotech recently received Breakthrough Device Designation from the FDA for two quick tests for the world's most dangerous drug-resistant pathogens. The company continues to actively participate at the major medical conferences, like ESCMID, Munich and MEDICA, Düsseldorf.

 

Atomo Diagnostics is also diversifying: Active syphilis tests are under development as are ALT biomarker tests for liver function assessment. Meanwhile, their platform, which serves as the backbone for their NG-Test, is poised to be the "gold standard for at-home testing and CLIA-waived in-clinic testing globally" according to the company.

 

The cooperation between these two innovative companies is an example of how collaboration in medical technology can yield great results. NG Biotech adds to assay development skills and Atomo adds device design skills. They have developed a product that fulfills the real clinical needs and that consumers are looking for, accurate, convenient, and reliable.

NG-Test Blood Precision hCG test is not just another pregnancy test, it's a new way of doing pregnancy testing. This innovation meets essential needs in women's health by merging the precision of lab blood tests with the speed of point-of-care diagnostics. The product has continued to expand its reach to new markets and applications, and it is a testament to the power of innovation and collaboration in solving real-world healthcare challenges.

 

The NG-Test platform is an excellent solution for women who want to know early if they are pregnant, providers who need accurate point-of-care testing, and health system professionals looking to increase efficiency and improve patient care and outcomes. The market for rapid diagnostics is rapidly growing worldwide and products such as the NG-Test will become even more important in providing access to advanced healthcare for everyone.