Delphi Bioscience Australasia - Delphi Screener D200

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by Delphi Bioscience Australasia

I, Jane Cook, Head, Pharmacovigilance & Special Product Access Branch, Therapeutic Goods Administration and delegate of the Secretary to the Department of Health, on receipt of an application from Delphi Bioscience Australasia, have approved under section 42DF of the Therapeutic Goods Act 1989 (the Act) the restricted representations described in paragraph (a) below for use in advertisements directed to consumers, for the product identified in paragraph (b), provided the conditions identified in paragraph (c) are met:

1.  
   1. The Delphi Screener is a new way of collecting a sample to detect Human Papillomavirus (HPV) infection
   2. The Delphi Screener can be used for HPV screening as part of cervical cancer screening
   3. Recurrent HPV infection is a known contributor to the development of cervical cancer
   4. Cervical cancer can be detected by timely screening
   5. Previously you had to have a pap smear to collect a sample for HPV detection. Now you can take the sample yourself.
2. Delphi Screener D200 (ARTG No. 219095)
3.  
   1. The restricted representations must only be used in conjunction with statements to the following effect, prominently displayed:
      1. In the event of a positive HPV test result, a physical examination by a doctor will be necessary
      2. The Delphi Screener does not form part of the Australian Government’s cervical cancer screening program
      3. The results of your HPV test may be recorded in a cancer screening register administered by either a State, Territory, or the Commonwealth Government.
   2. This approval is valid only until 1 May 2017.
   3. Use of the representations is permitted on condition that the Device is available only after a consultation with a doctor.

Dated this 7 day of September 2015

Jane Cook
Delegate of the Secretary to the Department of Health; and
Head
Pharmacovigilance & Special Product Access Branch