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Dx Focus: Akonni TruDiagnosis Studies; Spartan Bio CYP2C19 Test; Mitomics Prostate Cancer Assay


Akonni Biosystems this week announced the results of three preclinical studies in support of the efficacy of its TruDiagnosis molecular diagnostics platform and TruArray tests, and said that the platform is now ready for expanded, multi-site clinical trials.

The company conducted studies for the three assays — for methicillin-resistant Staphylococcus aureus, multi-drug resistant Mycobacterium tuberculosis, and influenza subtyping — using more than $45 million in private and public funding from the National Institutes of Health, US Centers for Disease Control, National Science Foundation, and the Department of Defense.

Akonni's TruArray tests combine conventional target amplification, fragmentation, and labeling processes into a single tube or microfluidic chamber. All amplification, labeling, hybridization, and wash steps can be combined into a single, self-contained amplification microarray consumable, resulting in an entirely closed-amplicon microarray-based test that is read on the TruDiagnosis array reader.

For its MRSA program, Akonni collaborated with researchers from Johns Hopkins University to conduct a retrospective study on 87 clinical isolates and 246 nasal swab samples acquired from a non-random, high-risk patient population. Of the 87 isolates, the TruArray test accurately classified 86, or 98.8 percent; and correctly identified 14 mecA dropout specimens that were falsely positive in the BD GeneOhm MRSA or BD GeneOhm StaphSR tests. The overall prevalence of MRSA in the clinical sample set was 16.7 percent.

The TruArray test had 80.5 percent sensitivity and 96.6 percent specificity, comparable to or better than Cepheid's Xpert MRSA or BD's GeneOhm tests when applied to similar, high-prevalence patient populations containing a significant number of mecA dropouts. This study was published in 2012 in the Journal of Microbiological Methods.

In its MDR-TB program, Akonni collaborated with JHU researchers to study 185 M. tuberculosis isolates representing a worldwide distribution of rifampin, isoniazid, streptomycin, and ethambutol resistance genotypes. A TruArray Test containing 96 unique probes for 39 drug-resistant mutations in five genes enabled a single technician to run up to 24 samples in under six hours using an industry-standard thermal cycler and a field-portable, low-cost microarray imager. Of 196 mutations in the culture set that were also represented on the microarray, the TruArray test correctly detected 193, a 98.4 percent success rate. This study is scheduled to be submitted for publication in the first quarter of 2013, Akonni said.

For its influenza program, Akonni worked with the CDC, New York Department of Health's Wadsworth Center, and Little Company of Mary Hospital. Akonni developed a simplified TruArray Test for influenza detection, sub-typing, and neuraminidase resistance detection from nasopharyngeal swabs in viral transport medium. Limits of detection in clinical nasopharyngeal swab samples were approximately 100 RNA gene copies per test, regardless of influenza subtype. The most sensitive probes were those targeting seasonal and pandemic influenza A H275Y variants. Using a CDC surveillance and reporting guideline, definitive identification was provided for 164 of 178 samples, or 92 percent, and 328 of 342 hybridizations, or 95.9 percent; and no false positives were detected. This study is also scheduled to be submitted for publication in the first quarter of 2013, Akonni said.

The studies demonstrate that Akonni has "minimized the technology risks of our platform, and it is time to expand these studies and begin the development and validation processes for regulatory approval," Kevin Banks, vice president of strategic development at Akonni, said in a statement. "This year we expect to find funding partners so we can design and initiate these trials. Once we have gained CE-IVD and FDA clearances, we believe our lower cost MDx tests will facilitate better and more rapid treatment decisions in the clinic."

Frederick, Md.-based Akonni is also developing a warfarin pharmacogenetic test that discriminates three SNPs in the CYP2C9 and VKORC1 genes, in less than four hours from sample lysis to result, for up to 24 samples at a time by a single technician; and has developed and verified an amplification microarray for monitoring microbial community dynamics in groundwater.

Spartan Bioscience said this week that it has submitted a 510(k) premarket notification application to the US Food and Drug Administration requesting regulatory clearance for its Spartan RX CYP2C19 genetic test.

The test runs on the Spartan RX system, a fully automated, point-of-care PCR-based testing platform that the company claims can complete a genetic test such as the CYP2C19 assay in an hour or less.

Last month, the Ottawa, Ontario-based company commenced a 5,945-patient study to investigate using its assay for personalized therapy in cardiac stent patients (PCR Insider, 12/20/2012). The study, sponsored by the Center for Individualized Medicine at the Mayo Clinic, is entitled "Tailored Antiplatelet Initiation to Lessen Outcomes due to Clopidogrel Resistance after Percutaneous Coronary Intervention, or TAILOR-PCI, and will evaluate whether genotyping cardiac stent patients at the time of angioplasty can help improve patient outcomes by informing providers about drug selection of either ticagrelor, marketed by AstraZeneca as Brilinta; or clopidogrel, marketed by Bristol-Myers Squibb and Sanofi-Aventis as Plavix.

Mitomics said this week that it has entered into a sales and marketing agreement for its Prostate Core Mitomic Test with Sterling Pathology National Laboratories.

Under the agreement, Sterling Pathology National Laboratories will sell PCMT to urologists throughout the US on a non-exclusive basis.

Conducted in Mitomics' CLIA-certified lab in Aurora, Colo., PCMT uses quantitative PCR to detect mitochondrial DNA deletions in existing prostate biopsy material. These deletions appear in benign tissue when a tumor is present in adjacent tissue, a phenomenon known as the cancerization field effect.

By detecting these alterations, the PCMT can enhance tumor detection in instances where biopsy cores appear histologically benign because they have failed to intersect tumor tissue, Mitomics said, adding that initial prostate biopsies can miss 25 percent to 60 percent of all cancers.

PCMT has demonstrated that its assay has a sensitivity of 85 percent and negative predictive value of 92 percent, and said that the test "is one of the most accurate and safest tests currently on the market for the detection of prostate cancer."

Mitomics has inked similar sales and marketing agreements for its test with QDx Pathology, Bostwick Marketing, LabMD, and Laboratory Corporation of America in the US; and CML Healthcare in Canada.