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Immunexpress Receives FDA Clearance for Direct-From-Blood Sepsis Test

NEW YORK (GenomeWeb) – Immunexpress said today it has received 510(k) clearance from the US Food and Drug Administration for the use of its Septicyte Lab, an RNA-based blood test that helps clinicians determine whether an infection has caused a patient's systemic inflammation.

Immunexpress noted that being able to rapidly differentiate infection-positive systemic inflammation, or sepsis, from infection-negative systemic inflammation, or systemic inflammatory response syndrome (SIRS), can save lives and reduce healthcare costs.

"Standardized, rapid, and objective diagnostics are needed for better clinical agreement in these patients," Immunexpress Chief Medical Officer Roy Davis said in a statement.

The Immunexpress blood test aids in differentiating infection in all suspected sepsis patients within four-and-a-half hours from a sample draw. In 447 suspected sepsis patients, the RNA test predicted all patients with a positive blood culture, Immunexpress said. The test will also aid in implementing clinical decisions about patients without infection where de-escalation of care and reducing antimicrobial treatment are appropriate, the firm said.

The firm's technology, operating directly from whole blood, uses RT-qPCR to rapidly quantify the host response by identifying the presence of four molecular blood markers from the patient's immune system. Detecting the host's response to infection has the potential to differentiate infection earlier, faster, and more accurately than finding the invading pathogen, because it is independent of whether or not the pathogen is present in the sample, Immunexpress added.

The company also noted that it is in "advanced discussions" with potential partners, including IVD and point-of-care instrument companies, for the development of automated versions of the test that it will then submit to the FDA for clearance. The company is also in "discussions with a key IVD partner" to conduct a staged, commercial launch of its Septicyte Lab test in the second half of 2017.

The firm noted that its product pipeline includes several assays for readily available instruments, including random access, point-of-care, and sample-to-answer systems.