Bacterial Infections: Page 2

Inflammatix secures $7.4M in BARDA funding

The funding will allow the company to further develop its point-of-care test for diagnosing infection and is part of a larger BARDA contract worth up to $72 million if milestones are met, the company said.

October 28, 2020

Tangen wins contract for Candida auris point-of-care test

The C. auris test will run on the company's TangenDx platform, which includes an assay kit and the company's GeneSpark analyzer. Tangen currently markets rapid tests for bloodstream Candida infections, bacterial infections, and antimicrobial resistance. It plans to file an emergency use authorization for a point-of-care COVID-19 test with the U.S. Food and Drug Administration this summer.

June 28, 2020

Procalcitonin test signals infection in heart attack patients

As an important marker for inflammation in the body, a blood test for PCT is useful for systemic bacterial infections and sepsis. But its value for detecting infection in patients with acute ST-elevation myocardial infarction (STEMI) -- an area of unmet need -- has been unclear. One key question is whether it is specific enough for infection, or whether levels would increase due to cardiac injury -- a limitation of other inflammatory biomarkers such as C-reactive protein (CRP) and white blood cell counts.

June 15, 2020

Lumos gets cash to expand reach of respiratory test

Lumos is a Planet Innovation spin-off that merged with RPS Diagnostics in May 2019. The company plans to use the funding to support international market expansion of its FebriDx point-of-care (POC) respiratory infection test, as well as a pivotal trial to support approval of the product by the U.S. Food and Drug Administration (FDA).

February 5, 2020

Inflammatix gets $32M infusion for HostDx rapid POC tests

Based in Burlingame, CA, Inflammatix is developing blood and nasal swab tests for the detection of infections and antibiotic resistance. Its platform is informed by machine-learning algorithms and gene expression patterns to identify bacterial and viral infections, and it yields results in 30 minutes or less, according to the company.

January 9, 2020

T2 Biosystems recruits Chembio's John Sperzel as new CEO

In the statement about the appointment, T2 noted that during his tenure at Chembio, Sperzel established U.S. and international sales teams that generated significant growth, and the company also made commercial investments in Latin America and Southeast Asia. Sperzel is replacing John McDonough, who will continue to serve as nonexecutive chairman of the board.

January 8, 2020

Sequencing test spots dangerous infections early in kids with cancer

The prospective study of 47 patients evaluated the sensitivity and specificity of the plasma microbial cell-free DNA sequencing (mcfDNA-seq) Karius test for identifying bloodstream infections three days prior to symptoms. The subjects were younger than 25 with relapsed or refractory leukemia treated at St. Jude Children's Research Hospital in Memphis, TN.

December 19, 2019

ATS, IDSA revamp pneumonia testing guidance

The new recommendations apply to the diagnosis and treatment of community-acquired pneumonia, from the time of signs and symptoms through treatment with antibiotics and follow-up chest imaging. They were published by a multidisciplinary team, including Dr. Joshua Metlay, PhD, chief of internal medicine at Massachusetts General Hospital (American Journal of Respiratory and Critical Care Medicine, October 1, 2019, Vol. 200:7, pp. e45-e65).

October 2, 2019

T2 Biosystems advances new tests through BARDA funding

The agreement with BARDA, which is part of the preparedness and response arm of the Department of Health and Human Services, will cover the development of three new direct-from-blood panels, according to the company. One panel will detect biothreat pathogens, including Bacillus anthracis and Francisella tularensis. The second is a comprehensive panel for detecting 99% of bloodborne bacterial infections by means of more than 30 reported results, including pan-Gram positive and pan-Gram negative results.

September 11, 2019

T2 Biosystems wins Medicare payment approval

As of October 1, 2019, U.S. hospitals treating Medicare inpatients with sepsis will now be eligible for a maximum NTAP amount of $97.50 -- 65% of the list price for one test -- for the T2Bacteria panel in addition to the appropriate sepsis diagnosis-related group (MS-DRG) reimbursement that hospitals receive under the Medicare hospital inpatient prospective payment system (IPPS), according to T2. The T2Bacteria panel is designed to detect sepsis-causing bacterial pathogens in the bloodstream in three to five hours without a blood culture.

August 6, 2019

GlaxoSmithKline recruits SpeeDx for antibiotics trials

SpeeDx markets in vitro testing products internationally that are aimed at minimizing the spread of treatment-resistant infections. Such products include ResistancePlus GC for Neisseria gonorrhoeae bacteria, which recently received the breakthrough device designation from the U.S. Food and Drug Administration (FDA), and ResistancePlus MG for detecting the emerging sexually transmitted infection Mycoplasma genitalium (Mgen). In a statement, the company said that it will use its existing molecular diagnostic tests as well as custom products to assist GlaxoSmithKline in ongoing trials and new product development.

June 23, 2019

Labs gear up to diagnose novel fungal infection

In the past few years, more than 600 cases of an emerging fungal infection called Candida auris have been identified in 12 U.S. states, according to the CDC.

April 14, 2019

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