T2 Biosystems Affirms Plans to Add Candida Auris Detection to the FDA-Cleared T2Candida Panel

Rhea-AI Summary

T2 Biosystems (NASDAQ:TTOO) announced plans to enhance its FDA-cleared T2Candida Panel by adding the detection of the multidrug-resistant fungal pathogen Candida auris. This pathogen poses a significant threat, with a mortality rate of up to 60%, especially among vulnerable populations. The CDC highlights the challenge of identifying Candida auris using conventional lab methods, which can hinder effective treatment. T2's innovative test aims to provide faster detection directly from blood samples, potentially improving patient outcomes. The company is also pursuing partnerships to expedite commercialization of this test.

Positive

• Plans to integrate Candida auris detection into the T2Candida Panel, expanding its diagnostic capabilities.
• The T2Candida Panel is already FDA-cleared, enhancing credibility and market trust.
• Potential for faster patient treatment through direct-from-blood testing, improving clinical outcomes.

Negative

• Dependence on successful FDA filings and clearances for new product features.
• Market risks associated with delays in securing partnerships for commercialization.

LEXINGTON, Mass., March 23, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today affirmed plans to add detection of the fungal pathogen Candida auris to the Company’s FDA-cleared and CE marked T2Candida^® Panel.

According to a March 21, 2023 Wall Street Journal report, Candida auris is a multidrug-resistant pathogen labeled by the Centers for Disease Control and Prevention (CDC) and World Health Organization as a growing threat to public health. The report described Candida auris as a “deadly fungus spreading across the U.S., mostly in healthcare facilities,” and stated that Candida auris has a mortality rate of up to 60%, and that older people or those with compromised immune systems are at greater risk.

According to the CDC, Candida auris is difficult to identify with standard laboratory methods, which can lead to inappropriate treatment, and that some strains are resistant to all three available classes of antifungal therapies. The CDC estimates the costs associated with fungal diseases in general in the U.S. are as high as $48 billion annually, and has called on public health professionals to help lower the burden of fungal disease by continuing to raise awareness of the life-saving benefits of early diagnosis and proper treatment.

"With prior support from the CDC, we have completed feasibility and early development of a diagnostic test to detect the Candida auris pathogen directly-from-blood and we plan to add this test to our FDA-cleared T2Candida Panel,” stated John Sperzel, Chairman and CEO of T2 Biosystems. “We believe adding Candida auris detection to our existing T2Candida Panel can accelerate time to detection and targeted treatment, compared to blood culture-based diagnostic methods, and we are exploring partnerships to accelerate our path toward commercialization.”

The T2Candida Panel is the only FDA-cleared diagnostic test able to detect sepsis-causing fungal pathogens directly from whole blood, without the need to wait days for a positive blood culture. The T2Candida Panel runs on the fully-automated T2Dx^® Instrument and simultaneously detects five Candida species, including Candida albicans, Candida tropicalis, Candida parapsilosis, Candida krusei, and Candida glabrata. Rapid detection of these pathogens, as well as Candida auris, is essential to getting infected patients on appropriate antimicrobial therapy and improving clinical outcomes.

About T2 Biosystems
T2 Biosystems, a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, is dedicated to improving patient care and reducing the cost of care by helping clinicians effectively treat patients faster than ever before. T2 Biosystems’ products include the T2Dx^® Instrument, the T2Bacteria^® Panel, the T2Candida^® Panel, the T2Resistance^® Panel, and the T2SARS-CoV-2™ Panel and are powered by the proprietary T2 Magnetic Resonance (T2MR^®) technology. T2 Biosystems has an active pipeline of future products, including the T2Biothreat™ Panel, the T2Cauris™ Panel, and T2Lyme™ Panel, as well as next-generation products for the detection of bacterial and fungal pathogens and associated antimicrobial resistance markers. For more information, please visit www.t2biosystems.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the ability of the Company to add detection of Candida auris to the T2Candida Panel, the ability of the Company’s test panels to detect the Candida auris pathogen, timing of filing of an FDA submission, and the ability of the Company to secure partnerships to accelerate commercialization of the Candida auris test, as well as statements that include the words “expect,” “may,” “should,” “anticipate,” and similar statements of a future or forward-looking nature. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, (i) any inability to (a) realize anticipated benefits from commitments, contracts or products; (b) successfully execute strategic priorities; (c) bring products to market; (d) expand product usage or adoption; (e) obtain customer testimonials; (f) accurately predict growth assumptions; (g) realize anticipated revenues; (h) incur expected levels of operating expenses; or (i) increase the number of high-risk patients at customer facilities; (ii) failure of early data to predict eventual outcomes; (iii) failure to make or obtain anticipated FDA filings or clearances within expected time frames or at all; or (iv) the factors discussed under Item 1A. “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, filed with the U.S. Securities and Exchange Commission, or SEC, on March 23, 2022, and other filings the Company makes with the SEC from time to time, including our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, unless required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. Thus, no one should assume that the Company’s silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release.

Investor Contact:
Philip Trip Taylor, Gilmartin Group
ir@T2Biosystems.com
415-937-5406

FAQ

What is T2 Biosystems planning to add to its T2Candida Panel?

T2 Biosystems plans to add detection of the fungal pathogen Candida auris to its T2Candida Panel.

Why is <b>Candida auris</b> a concern for public health?

Candida auris is a multidrug-resistant pathogen with a mortality rate of up to 60%, making it a growing health threat.

What are the potential benefits of the new <b>Candida auris</b> detection test?

The test can accelerate detection and targeted treatment, leading to improved patient care.

What is the current FDA status of the T2Candida Panel?

The T2Candida Panel is currently FDA-cleared and ready for the addition of Candida auris detection.

How does T2 Biosystems plan to commercialize the new test for <b>Candida auris</b>?

T2 Biosystems is exploring partnerships to accelerate the commercialization of the new Candida auris detection test.