LuViva® Advanced Cervical Scan_INTL

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Medical Professionals

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The LuViva® Advanced Cervical Scan uses biophotonics to scan the entire uterine cervix and distal endocervix for the presence of moderate to high-grade dysplasia.
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Distributors

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Guided Therapeutics is currently seeking qualified international medical device distribution partners with an established presence in the gynecology field.
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Patients

Cervical cancer is the leading cause of cancer deaths in the developing world for women of child bearing age. More Information...

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LuViva

Cervical Cancer Detection

Globally, cervical cancer is the second-most common cancer in women.1 Typically, an abnormal Pap test (cytology) or human papillomavirus (HPV) test is followed up with a colposcopy exam and biopsy.2–4 Early detection with these tests has reduced cervical cancer mortality.1 The tests may, however, produce 2–4

  • False-positive results, leading to additional, unnecessary tests and procedures, increased institutional costs, and patient stress and anxiety
  • False-negative results, leading to delays in disease diagnosis

Introducing LuViva® Advanced Cervical Scan

LuViva is a point-of-care device using fluorescence and reflectance spectroscopy to scan the entire uterine cervix for detecting moderate to high-grade cervical dysplasia (cervical intraepithelial neoplasia [CIN] 2 or higher).  LuViva is used before colposcopy or indicated as a follow-up or recall procedure to triage the disease state of women with an abnormal cytology or other risk factors.

LuViva Is Recommended for Women 16 Years of Age or Older Who:

  • Have abnormal cytology or positive HPV findings 
  • Have other risk factors (eg, previous dysplasia)
  • Need additional evaluation before colposcopy or biopsy

 

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Testing-with-LuViva

 

2Year_FollowUp_3

Benefits and Risks of LuViva®

  • Is noninvasive and fast (real-time results in about a minute)
  • May reduce the number of women with normal cervices or low-grade disease having to undergo colposcopy or biopsy5 
  • May increase the detection of CIN2+ disease missed by other tests and procedures5
  • Does not require interpretation by an outside laboratory

 

 
 
References:1. Comprehensive cervical cancer prevention and control: a healthier future for girls and women. World Health Organization Web site. http://apps.who.int/iris/bitstream/10665/78128/3/9789241505147_eng.pdf. Accessed April 17, 2014. 2. TOMBOLA Group. Biopsy and selective recall compared with immediate large loop excision in management of women with low grade abnormal cervical cytology referred for colposcopy: multicentre randomised controlled trial. BMJ. 2009;339:b2548. 3. Luesley D, Downey G. Value of normal colposcopy after an abnormal cervical smear report. J Low Genit Tract Dis. 2009;13(1):33-37. 4. Goksedef BP, Akbayir O, Baran SY, et al. Atypical squamous cells of undetermined significance in postmenopausal women: a comparative retrospective analysis. Eur J Obstet Gynecol Reprod Biol. 2011;159(2):418-421. 5. Twiggs LB, Chakhtoura NA, Ferris DG, et al. Multimodal hyperspectroscopy as a triage test for cervical neoplasia: pivotal clinical trial results. Gynecol Oncol. 2013;130(1):147-151. 6. Data on file. Guided Therapeutics, Inc. 7. LuViva® Advanced Cervical Scan User’s Manual. Guided Therapeutics, Inc. November 2013

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Guided Therapeutics, Inc. is located in Peachtree Corners, Georgia, northeast of Atlanta.

5835 Peachtree Corners East Suite B
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