First Non-Invasive Test for Both H. Pylori and Clarithromycin Resistance Gets CE Mark

Mobidiag, a Finnish molecular diagnostics company, has received the CE mark for its Amplidiag H. pylori+ClariR test, intended as a primary test for suspected Helicobacter pylori (H. pylori) infection. This qualitative real-time PCR-based test is the first non-invasive molecular diagnostic that detects both H. pylori and one of its key resistances to clarithromycin. The test is performed directly from stool DNA extract.

The current primary diagnostic tests for H. pylori include stool antigen tests, urea breath tests, and serological tests. These assays do not detect antibiotic resistance, however, and when antibiotic therapy fails, secondary diagnostics rely on gastric biopsy and subsequent pathogen culturing and antibiotic susceptibility testing. With Amplidiag H. pylori+ClariR’s ability to detect antibiotic resistance in conjunction with the pathogen, clinicians can target primary eradication therapy without the patient undergoing invasive procedures or long wait times. In the long term, Mobidiag hopes the test will contribute to preventing gastric cancer, which is consistently associated with H. pylori infection.

The test was evaluated with nearly 300 clinical samples and compared to two commonly used stool antigen tests. All positive findings were also sequenced to verify the results and the correct identification of the clarithromycin resistance gene mutations. The sensitivity and specificity for H. pylori identification were established as 93.1% and 99.2%, respectively, while both figures were 100% for clarithromycin resistance mutation detection.

FDA Announces Public Workshop on Non-Microbial Biomarkers of Infection

This fall, the Food and Drug Administration (FDA) will hold the public workshop, “Non-Microbial Biomarkers of Infection for In Vitro Diagnostic Device Use,” with the aim of gathering input on approaches to the study of non-microbial biomarkers that differentiate viral from bacterial infections, as well as for the diagnosis and assessment of sepsis.

Diagnostics that can differentiate a bacterial etiology from other causes of illness (such as viral, fungal, or non-infectious) could significantly impact antibiotic stewardship, and potentially, antimicrobial resistance. Progress in this area has been hindered, however, by a lack of consensus on important issues in clinical trial design for new analytes, including clinical definitions of different disease states, acceptable device performance, and acceptable comparator performance.

The workshop will take place in Silver Spring, Maryland on October 16. Anyone interested in attending should register by 4 p.m. on October 6.

Ventana Receives FDA Approval for Co-Diagnostic to Guide Lung Cancer Treatment

The Food and Drug Adminis­tra­tion (FDA) has approved the Ventana ALK (D5F3) CDx assay as a companion diagnostic to identify lung cancer patients who might benefit from treatment with Xalkori (crizotinib), an anaplastic lymphoma kinase (ALK) inhibitor. This immunohistochemistry (IHC) test identifies pathologic expression of an ALK fusion protein that is a biomarker for non-small cell lung cancer (NSCLC). In patients who test positive for this protein, inhibition of the ALK tyrosine kinase has been shown to lead to tumor shrinkage. Traditional testing methods for ALK mutation status use fluorescent in situ hybridization and have a time-to-result of weeks. With an approved IHC test for ALK, patients now can learn their mutation status and start an ALK-targeted therapy within days.

Ventana’s ALK (D5F3) CDx assay was also approved in Europe in 2012 and by the Chinese FDA in 2013.