Screens for cervical cancer, HPV, and STIs
Originally introduced in 1996, the ThinPrep PAP test from Hologic, Bedford, Mass, has become the most widely used PAP test in the United States, according to a 2012 report. ThinPrep is the only test approved for both PAP and HPV testing from a single vial, enabling physicians to screen patients for cervical cancer, HPV, and STIs. Only a single specimen needs to be collected, increasing patient comfort, convenience, and efficiency by reducing the number of vials that need to be handled and minimizing the possibility of losing or mixing up samples. Lab results are also more likely to be reported together. The ThinPrep test has been approved or cleared by FDA for a wide range of additional assays, including the Aptima Combo 2 test for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG), the Aptima Trichomonas test, BD ProbeTec CT, BD ProbeTec NG, and Roche Cobas Amplicor CT/NG.
(781) 999-7300; www.hologic.com
Cleared for cervical cancer primary screening
The Cobas HPV Test from Roche Molecular Diagnostics, Pleasanton, Calif, has received FDA clearance for use as a first-line screening test for cervical cancer in women 25 and older. New interim clinical guidance from the Society of Gynecologic Oncology and the American Society for Colposcopy and Cervical Pathology supports the use of an FDA-approved test for primary HPV screening for cervical cancer in this population. The Roche qualitative multiplex assay detects 14 high-risk HPV types while providing specific genotyping information for types 16 and 18, which are responsible for about 70% of cervical cancer. The test is performed on the automated Cobas 4800 system, and the automated result algorithm provides clear positive, negative, or invalid results.
Roche Molecular Diagnostics
(925) 730-8000; www.molecular.roche.com
Cancer Gene Panels
Compatible with any NGS sequencer
Qiagen, Valencia, Calif, has introduced 14 new GeneRead DNAseq V2 gene panels targeting an extensive range of cancer-related genes or gene regions. Gene panels are an integral part of many next-generation sequencing (NGS) workflows and are used to enrich genes of interest in a sample prior to sequencing runs. The GeneRead panels are customizable to include other genes or gene regions of clinical or biological interest, and are compatible with any NGS sequencer. The panels include “focused” panels each targeting eight to 25 genes, “disease-specific” panels for 40 to 50 genes, and “comprehensive” panels for up to 160 genes. Laboratories can customize GeneRead panels for specific disease pathways or research needs via GeneGlobe, an online portal of more than 60,000 annotated molecular assays.
(800) 718-2056; www.qiagen.com
KRAS Screening Kit
Detects seven most common KRAS mutations
The Droplet Digital PCR (ddPCR) KRAS screening multiplex kit from Bio-Rad Laboratories, Hercules, Calif, offers improved sensitivity and simultaneous detection of the seven most common KRAS mutations in a single ddPCR experiment. KRAS mutations are found in 90% of pancreatic cancer cases and 30% of colorectal cancer cases. Used with Bio-Rad’s ddPCR technology, the multiplex kit is able to detect and quantify extremely low levels (down to 0.2%) of KRAS mutant DNA in a single assay, enabling researchers to derive results from limited quantities of starting material. The kit is the latest offering in Bio-Rad’s droplet digital PCR line of predesigned, fully wet-lab validated assays.
(800) 424-6723; www.bio-rad.com
Prostate Cancer Blood Test
Reduces false positives
The Prostate Health Index (PHI) from Beckman Coulter Diagnostics, Brea, Calif, reduces the need for men with elevated PSA levels to undergo biopsy to achieve an accurate diagnosis. The noninvasive blood test is three times more specific in detecting prostate cancer than prostate-specific antigen (PSA), a naturally occurring protein whose levels are typically elevated when cancer is present. Utilizing three PSA markers, including PSA, freePSA, and p2PSA, the PHI test avoids the risk of false positives associated with PSA testing due to benign enlargement or inflammation of the prostate. According to the company, a multicenter clinical study found a 31% reduction in unnecessary biopsies as a result of implementing the PHI test.
Beckman Coulter Diagnostics
(800) 526-3821; www.beckmancoulter.com
Fewer false positives compared to DNA-based testing
The Aptima HPV assay from Hologic, Bedford, Mass, targets high-risk human papilloma virus (HPV) mRNA from the E6/E7 oncogenes, offering the same sensitivity and improved specificity as compared to DNA-based tests. The assay enables clinicians to identify the presence of high-risk HPV infection, which is responsible for more than 99% of all cervical cancers. High sensitivity minimizes false negative results, while high specificity reduces the rate of false positive results, which can result in the overtreatment of patients. The clinical trial to support FDA approval of the Aptima HPV assay showed 24% fewer false positive test results compared to DNA-based testing. The test can also help clinicians more accurately target the right patients for colposcopy.
(781) 999-7300; www.hologic.com
Lung Cancer Companion Diagnostic
First based on liquid biopsies
The Therascreen EGFR RGQ Plasma PCR kit from Qiagen, Germantown, Md, is a novel liquid biopsy-based companion diagnostic that analyzes circulating nucleic acids obtained from blood samples to assess epidermal growth factor receptor (EGFR) mutation status in non-small cell lung cancer (NSCLC) patients. Having recently received CE-IVD marking, the test is the first regulated companion diagnostic assay to demonstrate clinical utility for guiding treatment decisions in patients with solid tumors based on a liquid biopsy. The kit helps physicians identify those advanced NSCLC patients who could benefit from treatment with Iressa, an EGFR-tyrosine kinase inhibitor that blocks signals for cancer cell growth, when a suitable tumor sample is not available. The test is performed on Qiagen’s Rotor-Gene Q PCR detection platform.
(240) 686-7700; www.qiagen.com
NGS Oncology Control
500 single-nucleotide variants
Thermo Fisher Scientific, Carlsbad, Calif, has launched its first universal quality control for next-generation sequencing (NGS) oncology tests. The AcroMetrix Oncology Hotspot control can be used across laboratories with different NGS instrument platforms, assays, and bioinformatics pipelines to test precision and detect analytical deviations that may arise from reagent and instrument variation. Allowing users to control for more than 500 hotspot mutations, the Oncology Hotspot control contains cancer-associated mutations across 53 genes, including KRAS, BRAF, ERBB2, EGFR, and TP53. Users can choose from 500 single-nucleotide variants, 18 insertions, 29 deletions, and three complex mutations. Containing both synthetic and genomic DNA, the control has a validated 12-month shelf life at -20°C and is stable over five freeze-thaw events.
Thermo Fisher Scientific
(760) 603-7200; www.thermofisher.com
Advanced NSCLC Blood Test
Assess differential treatment outcomes
VeriStrat from Biodesix, Boulder, Colo, is a blood-based test to help guide second-line treatments for patients with advanced non-small cell lung cancer (NSCLC) who do not have an epidermal growth factor receptor mutation, or whose mutation status is unknown. This noninvasive diagnostic assay predicts differential treatment outcomes between chemotherapy and the targeted drug erlotinib for second-line treatment of inoperable NSCLC. Physicians use VeriStrat results, in combination with the patient’s clinical history, other diagnostic tests, and other clinical and pathological factors to guide therapy decisions for NSCLC patients. No fasting is required, and results are typically reported within 72 hours of the blood draw.
(303) 417-0500; www.biodesix.com
BCR/ABL1 Quant Kit
Linear dynamic range across six logs
The BCR/ABL1 Quant kit from Asuragen, Austin, Tex, is a research tool that uses multiplex real-time quantitative RT-PCR to provide simultaneous detection and quantification of BCR-ABL1 kit fusion transcripts (e13a2, e14a2, and e1a2) and ABL1 (an endogenous control) in a single reaction. Based on Armored RNA technology for standard curve, the kit includes RNA-based calibrators for quantifying RNA and an analytical sensitivity of at least 1:105 and linear dynamic range across six logs. The kit integrates TaqMan technology and is compatible with ABI 7500 real-time systems or equivalent. The multiplexed format reduces reflex testing by providing quantitation of the three predominant BCR/ABL1 fusion transcripts in a single well, leading to cost and operational efficiencies. No additional reagents are required. For research use only.
(877) 777-1874; www.asuragen.com