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Dx Focus Jul 29, 2010: Clinical and Regulatory PCR and Nucleic Acid Testing News

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Gen-Probe said this week that the US Food and Drug Administration has cleared for marketing its Prodesse ProFast+ assay, making it the only FDA-cleared molecular diagnostic test to simultaneously detect and differentiate three common influenza A virus subtypes: seasonal A/H1, seasonal A/H3, and 2009 H1N1.

ProFast+ is a multiplex, real-time PCR in vitro diagnostic assay that detects influenza A from nasopharyngeal swabs. It uses the same internal control and format as other FDA-cleared Prodesse tests for respiratory infections. All Prodesse products have been optimized for use with automated extraction technology, and results can be obtained in as little as four hours, Gen-Probe said.

The ProFast+ complements the Prodesse ProFlu+ assay, which was cleared by the FDA in 2008 to detect and differentiate influenza A, influenza B, and respiratory syncytial virus, but does not differentiate among various influenza A subtypes.


Diatherix Laboratories said this week that it has added sexually transmitted disease and herpes simplex virus panels to its lineup of rapid response diagnostic panels.

The STD panel tests for Atopobium vaginae, Chlamydia trachomatis, Gardnerella vaginalis, Haemophilus ducreyi, Mycoplasma hominis, M. genitalium, Neisseria gonorrhoeae, Treponema pallidum, Trichomonas vaginalis, and Ureaplasma urealyticum, Diatherix said.

Both panels will be added to Diatherix's panels for infectious disease, Staphylococcus differentiation, respiratory infections, gastrointestinal disease, human papillomavirus typing, bacterial pneumonia, viral respiratory, and C. difficile.

All panels use the company's proprietary technology, called target-enriched multiplex PCR, which can identify multiple pathogens, co-infections, and highly transferable genetic antibiotic resistances simultaneously, Diatherix said.

Diatherix is located in the HudsonAlpha Institute for Biotechnology in Huntsville, Ala., and operates as an independent high-complexity CLIA-certified clinical lab.


Mira Dx recently announced the launch of the PreOvar real-time PCR-based test for women who may have inherited an increased risk for developing ovarian cancer.

Based on a genetic variant discovered by Yale University researchers, the test provides additional information for doctors and women at high risk of hereditary ovarian cancer.

Yale licensed the technology surrounding the test to Mira Dx to develop tests based on microRNAs. Specifically, the test assesses whether genetic variants in KRAS, a gene strongly associated with ovarian cancer, disrupt certain miRNA pathways, thus predisposing certain individuals to developing the disease.

The PreOvar test will be analyzed in Mira Dx's CLIA-certified lab in New Haven, Conn.


Seegene this week introduced new multiplex PCR tests for sepsis and for tuberculosis and multi-drug-resistant TB.

Seegene's sepsis test, called MagicPlex Sepsis, is a multi-pathogen screening test that can identify more than 90 leading sepsis-causing pathogens including more than 70 gram-positive organisms (30 Staphylococcus, 40 Streptococcus, and three Enterococcus); 12 gram-negative, six fungi, and three antibiotic-resistant genes (mecA, vanA, and vanB).

The test requires less than one 1 mL of a patient's whole blood and provides test results within three hours following extraction, Seegene said.

Meantime, Seegene's Anyplex MDR-TB test is a real-time PCR molecular diagnostic that can simultaneously detect TB and genetic mutations leading to multi-drug-resistant TB within four hours.

Specifically, healthcare workers using the test will be able to determine whether a patient is infected with a strain of TB that is resistant to isoniazid and rifampin, Seegene said.

Both Seegene's MagicPlex and AnyPlex tests use the company's proprietary dual-priming oligonucleotide, or DPO, and real-amplicon detection, or READ, PCR. Neither of the new tests have been cleared for diagnostic use in the US, Seegene said.

The Scan

Fertility Fraud Found

Consumer genetic testing has uncovered cases of fertility fraud that are leading to lawsuits, according to USA Today.

Ties Between Vigorous Exercise, ALS in Genetically At-Risk People

Regular strenuous exercise could contribute to motor neuron disease development among those already at genetic risk, Sky News reports.

Test Warning

The Guardian writes that the US regulators have warned against using a rapid COVID-19 test that is a key part of mass testing in the UK.

Science Papers Examine Feedback Mechanism Affecting Xist, Continuous Health Monitoring for Precision Medicine

In Science this week: analysis of cis confinement of the X-inactive specific transcript, and more.