Direct to the public parentage testing

35.87 As discussed in Chapter 11, direct to the public genetic testing refers to two different forms of genetic testing. One form is akin to home pregnancy testing, in which the test is performed and interpreted by the person at home. At present, this form of genetic testing for parentage is not available in Australia.

35.88 The second form is a test in which the person collects a bodily sample at home and sends it to a laboratory for analysis. Kits for testing may be made available through pharmacists or other retailers, by mail order or over the Internet. The samples are forwarded through the mail to the company offering the services, either in Australia or overseas, and the laboratory testing the samples may or may not be accredited. Home-based sample collection raises a number of concerns, which are discussed in Chapter 11.

Submissions and consultations

35.89 DP 66 proposed that home use parentage test kits should be subject to regulation under the Therapeutic Goods Act 1989 (Cth) and the Therapeutic Goods Regulations 1990 (Cth).^[90]

35.90 Most of the submissions addressing this proposal expressed support for it.^[91] Several submissions opposed the use of direct to the public kits in any circumstances.^[92] For example, Sydney IVF Limited commented that the inappropriate or inadequate use of such kits could lead to incorrect non-consensual sampling, or sample substitution.

Sydney IVF recommends that sample collection should always be supervised, for example in an approved pathology collection centre … the utilization of home use parentage kits can circumvent the responsibilities associated with the provision and acceptance of informed consent for testing.^[93]

35.91 In contrast, Genetic Technologies noted that home-use kits for DNA parentage testing are not sensitive to heat or aging, and concerns with contamination and ‘chain of custody’ can be mitigated by limiting the uses to which results from home-use testing can be put. It was noted that home based collection does not preclude a client from obtaining counselling or clinical interaction.^[94]

35.92 Dr Geoffrey Edelsten emphasised the potential additional cost to the consumer, which he argued would result from implementation of the proposal.^[95] However, the evidence available to the Inquiry suggests that the cost differential is relatively modest. For example, Genetic Technologies (an accredited laboratory) advised the Inquiry in 2001 that its standard fees for parentage testing were:

• paternity test involving samples from the mother, father and child: $825;

• home collection paternity test involving samples from the mother, father and child: $715; and

• home collection paternity test involving samples from the father and child (‘motherless’ testing): $935.^[96]

35.93 The last two listed tests are non-accredited because they are based on home collection of samples, but their costs do not differ substantially from the accredited test. The higher cost of ‘motherless testing’ is explained in part by the fact that more DNA loci must be tested where samples come from only two individuals.

Inquiry’s views

35.94 The availability of direct to the public parentage testing raises a range of concerns, including:

• the possibility of error and fraud where the genetic sample is collected without independent supervision;

• the possibility of sample contamination because the sample may not have been stored correctly or shipped to the laboratory under optimal conditions, or because the chain of custody of the sample cannot be verified;

• the possibility that appropriate informed consent may not have been obtained from the person; and

• the fact that persons are less likely to be referred for genetic counselling.

35.95 In Chapter 11, the Inquiry recommended that the Commonwealth should amend the law to enable the Therapeutic Goods Administration to regulate DNA identification test kits, including for parentage and other kinship testing used in genetic testing provided directly to the public. This recommendation adequately addresses the concerns raised in relation to direct to the public parentage testing, and no further recommendation is required.