|Type/Class of Therapy||Generic/Trade/ Company Names||Indication||Approving Regulatory Agency|
|HPV Infection||HPV RNA detection kit|
APTIMA® HPV Assay
|Regulatory clearance was granted to this in vitro nucleic acid amplification test, which is used with the TIGRIS® DTS® System (a diagnostic instrument for automated nucleic acid testing), to identify human papillomavirus (HPV) RNA from 14 high-risk genital HPV types that are commonly associated with cervical cancer.||US FDA|
|HPV DNA detection kit|
cobas® HPV Test
cobas® 4800 System
Roche Molecular Systems, Inc.
|This HPV test was approved for identifying women at highest risk for developing cervical cancer. It individually identifies genotypes 16 and 18 (the two highest-risk HPV genotypes responsible for >70% of cervical cancer cases), as well as detects 12 other high-risk HPV genotypes.||US FDA|
Miramar Labs, Inc.
|The US FDA granted 510(k) clearance to this hand-held apparatus utilizing electromagnetic energy for the treatment of primary axillary hyperhidrosis. The system uses microwave energy to induce thermolysis of the sweat glands. Onset of effect can occur immediately after the procedure. Two procedures are typically recommended 3 months apart to maximize efficacy and duration of benefit.||US FDA|
|Skin Cancer||Real-time PCR test for BRAF gene mutation|
cobas® 4800 BRAF V600 Mutation Test
Roche Molecular Systems, Inc.
|Device clearance was granted to this automated molecular assay to detect change in the BRAF gene. It serves as a companion diagnostic that determines a patient’s eligibility for treatment with vemurafenib (Zelboraf™), an oral, small molecule, kinase inhibitor for the treatment of metastatic or unresectable melanoma.||US FDA|
|Computer-assisted melanoma diagnostic system|
MELA Sciences, Inc.
|This optical imaging and analysis device is used for the early detection of melanoma. It captures, displays, and stores multispectral (from blue to near infrared) and reconstructed digital images of clinically atypical pigmented skin lesions, and uses automatic image analysis and statistical pattern recognition to generate a result.||EC/EMA (European Union)|
|Laser Raman spectroscopy system|
Verisante Technology, Inc.
|This optical system aids in the assessment of suspect skin lesions for diagnosis as benign changes, basal cell carcinoma, squamous cell carcinoma or melanoma, and provides immediate results. The device uses Raman spectroscopy to biochemically analyze the skin and automate the diagnostic process, allowing rapid scanning of 20-40 skin lesions on at-risk individuals.||EC/EMA (European Union)|
|Optical coherence tomography scanner|
Michelson Diagnostics Ltd.
|Although 510(k) clearance was granted in January 2010, US availability of this scanning product was announced in September 2011 and is indicated for use in the two-dimensional, crosssectional, real-time imaging of lesions to aid in the diagnosis of nonmelanoma skin cancer. Using near infrared light, the multibeam optical coherence tomography laser technique provides images of sub-surface tissues similar to ultrasound but at far higher resolution.||US FDA|
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