Thanks to those who joined our EYE ON IVD State of the IVD Industry Webinar 2024 last week – with participation from Broad Branch Advisors, CAP Today and IVD Logix.
US IVD FACES OVERSEAS COMPETITORS: At the 2024 ALDLM conference, analyst Frank Criscione of BroadBranch Advisors highlighted the growing presence of offshore competitors in the in vitro diagnostics (IVD) industry. “One [observation at ALDLM 2024] was that there was a very large presence of offshore competitors,” Criscione said. He noted that while these competitors currently lack FDA clearance, and therefore pose no immediate threat to the market in North America, they could present a substantial challenge in the long term. As these companies move toward FDA approval, their entry into the U.S. market may intensify competition for larger IVD players. “So in the near term, that’s not really an area of concern because most of these competitors don’t have FDA clearance. However, in the long term, as they do begin to apply for FDA clearance, they might be an actual substantial threat to some of the larger players in North America.”
“in the long term, as they do begin to apply for FDA clearance, [overseas IVD companies] might be an actual substantial threat”
CREDO GEARING TO ENTER PANEL US MARKET: There could well be an example in recent news – we note that Credo Diagnostics, an international IVD firm with CE marks in Europe, is planning to enter the U.S. market with its FLU/RSV/COVID molecular multiplex respiratory test. This according to a report in 360Dx. (www.360dx.com) Clinical trials are set to begin in November 2024, the firm says. Credo has been a presence at US meetings of AACC/ADLM for years, their m-poc VitaPCR product has CE Mark for COVID and Flu, and they produce other tests.
CHINA AND IVD: While we discuss entry into the US market of competitors, maybe it’s worth a look into IVD companies in the Chinese market? IVD firms continue to prosper in China in 2024, but growth is not in the percentages (double-digits in 2012-14) that was seen. Firms that enter now must be able to commit resources, stay a while, find partners and probably set up shop.
Top IVD is doing just that. For instance China Daily reports that Roche has made a large investment in Suzhou: https://www.chinadaily.com.cn/a/202408/22/WS66c68e37a31060630b924529.html that “Roche Diagnostics Products (Suzhou) Co Ltd signs an agreement with the Suzhou Industrial Park Administrative Committee to invest 3 billion yuan ($420 million) in the expansion of Roche Diagnostics Asia Manufacturing and R&D Site in Suzhou, Jiangsu province, on Aug 21, 2024.” China Daily says it is Roche’s largest investment in China.
“We have been active in China since the 1990s. China represents a sizable amount of total bioMérieux sales, being the 2nd biggest entity behind the US. bioMérieux is one of the leading players in China in the field of microbiology and a niche player in the Chinese immunoassays market.” – Vincent Chan, GM, Greater China, Mérieux China Ltd
Not to be outdone- bioMérieux has a “long-term commitment” in China, according to GM Vincent Chan, with a local distribution entity based in Shanghai, one manufacturing plant in Suzhou for BacT/Alert bottles, the holding company of a local Chinese immunoassay company, Hybiome, located in Suzhou, Jiangsu, and a minority stake in a local molecular Chinese company, Accunome, located in Jiaxing, Zhejiang. Chan said he expected growth because of government investment.
The canal-rich and long-time industrially-developed Suzhou is 40 miles (this US fellow eyeing a map) approx. from Shanghai and in position for trade internationally. The cities “Gate to the East” is a 74-story skyscraper in Suzhou’s central business district, built in 2015 at a cost of 700 million USD and is currently the tallest building in Suzhou.
INFECTION TESTING NEWS: Abbott recently received FDA clearance for its Alinity I Toxo IgM immunoassay, which aids in diagnosing acute or recent Toxoplasma gondii infections. The test detects IgM antibodies and is designed to be used in conjunction with a T. gondii IgG assay. The company says the product strengthens Abbott’s already robust portfolio of diagnostic solutions. In addition, Inflammatix, a molecular diagnostics firm, raised $57 million to fund the commercialization of its TriVerity Acute Infection and Sepsis Test, which differentiates bacterial, viral, and noninfectious diseases in, the firm claims, only 30 minutes. The test utilizes a machine-learning algorithm to analyze 29 mRNA markers and predict disease progression. The company is aiming sales to the ER.
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TRIPLE E THREAT IN THE NEWS: There is growing concern over Eastern Equine Encephalitis (EEE), a mosquito-borne virus that is rare but extremely severe. A recent case in Ulster County, New York, resulted in the death of a human, the first such case in the state since 2015. In response, New York state has implemented a series of preventive measures, including mosquito spraying and public awareness campaigns. EEE poses a serious health threat as there are currently no vaccines or treatments available for humans. The virus tends to surface in late summer and early fall and has a high fatality rate, particularly in horses, where the death rate can reach 90%. While preventive efforts have been ramped up, EEE remains a significant public health concern.
HEPATITIS B RECLASSIFICATION: The FDA has announced plans to reclassify several types of hepatitis B virus (HBV) tests from Class III (high risk) to Class II (moderate risk), easing the regulatory burden for these devices. This change will apply to HBV antigen, antibody, and nucleic acid assays, making it easier for companies to bring these tests to market through the 510(k) or de novo regulatory pathways, rather than requiring full premarket approval. This shift reflects the tests’ established safety records and low incidence of adverse events. A reclassification can improve the time to market and thus be market-expansive.
A reclassification in Hepatitis B tests can improve the time to market and thus be market-expansive.
Hepatitis B is a viral infection that primarily affects the liver, and it is considered one of the most serious forms of hepatitis due to its potential to become chronic. Hepatitis B differs from hepatitis A and C in several key ways. Hepatitis A is typically transmitted through contaminated food and water and usually results in an acute infection from which most people fully recover without long-term complications. Hepatitis C, while also a viral liver infection, is most commonly spread through blood-to-blood contact and often leads to chronic liver disease, but it can now be effectively treated with antiviral medications.
Hepatitis B is unique in that it is transmitted through blood, semen, and other bodily fluids, making it a major risk factor for healthcare workers, individuals with multiple sexual partners, and those in close contact with infected persons. A significant portion of those infected with HBV may not show symptoms, but the virus can still lead to severe liver complications, including cirrhosis and liver cancer, particularly for those with chronic infections. It is estimated that between 580,000 and 1.2 million people in the U.S. have chronic hepatitis B, with many unaware of their condition. For this reason, reliable HBV tests are crucial for diagnosing acute or chronic infections and connecting patients with the appropriate antiviral treatments. These tests play a vital role in public health efforts to reduce transmission and prevent the long-term complications associated with hepatitis B.
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