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Furnetics Unlimited Ltd. today opens the Genetic Select™ service line, the fourth and final of the commercial offerings that the corporation intends to carry on its standing product register. Genetic Select™ delivers pre-conception carrier screening for prospective parents and, in co-ordination with a partner clinic of the parents' own choosing, preimplantation genetic diagnosis of the embryos produced by that partner clinic's assisted-reproductive-technology programme. The line has been developed over the four years since the corporation's arrival in Ulaanbaatar, at the request of the (then internal-only) Clinical Review Board, and was authorised as a formal procedure class by the newly-constituted Independent Ethics Board at the Board's inaugural session in June of the present year. It is opened today under the strictest eligibility framework the corporation has yet published for any of its four lines, and under an availability matrix rather narrower than that of the three lines which precede it.

The corporation is acutely conscious of the ground into which it now steps. Preimplantation genetic diagnosis and pre-conception selection are practices upon which the settled medical, legal, and moral opinion of the world has neither converged nor stopped moving, and are practices which, in the several jurisdictions where they are lawful at all, are hedged with the kind of restrictive conditions that the corporation has, for reasons peculiar to its subject matter, always preferred to draft for itself rather than to receive at the hand of a legislature. The eligibility framework set out below is the framework the corporation has chosen to impose on itself as the condition of offering the line, and it is a framework the corporation intends to enforce with the same care with which it drafted it. It will be revised, if at all, only by the standing quarterly process of the Independent Ethics Board, and never in the direction of expanding what the corporation is prepared to do.

What the line is

Genetic Select™ has two arms, both of which the prospective parents must have consented to before the line's first appointment can be scheduled. The first is a comprehensive pre-conception carrier screen, delivered on both prospective parents at the Ulaanbaatar campus over the course of a single visit, which characterises the couple's risk of transmitting any of the sixty-two heritable conditions currently on the corporation's screening panel, together with the smaller supplementary panel of conditions the prospective parents have themselves elected on the advice of a genetic counsellor. The output of the first arm is a written report, delivered to the prospective parents and to their nominated clinician, on the basis of which the prospective parents may elect either to pursue conception without further Furnetics involvement, or to proceed to the second arm of the line, or to withdraw from the process altogether. Only the third of these outcomes carries no fee.

The second arm is preimplantation genetic diagnosis, performed at the corporation's laboratory on embryos produced by the prospective parents' partner clinic of assisted-reproductive-technology practice. Furnetics does not itself perform in-vitro fertilisation, does not itself perform embryo transfer, and does not itself provide gametes or arrange gamete donation; the prospective parents' partner clinic remains the treating institution for every step of the reproductive procedure other than the diagnostic and, where the prospective parents so elect, the selection workflow itself. The corporation's role in the second arm is limited to the receipt and diagnostic characterisation of a numbered set of embryos, the return of a written report to the treating clinic, and, at the treating clinic's request, the co-ordination of return transport of the selected embryo or embryos to that clinic under validated cold-chain conditions. The corporation does not itself store embryos beyond the immediate term of the diagnostic; it does not itself dispose of embryos not selected; and the disposition of any embryo not returned to the treating clinic remains, at every point, a matter for the prospective parents and their treating clinic to settle between them.

“It has taken us four years to bring this line forward and we would rather have taken five. Genetic Select is the line at which every question the corporation has ever asked itself — about what medicine may propose, about what a client may elect, about what a corporation may decline to do even when its client has asked — is asked at once, and asked in its most exacting form, because the client on whose behalf the election is made cannot yet speak. We are opening the line because we believe we have answered those questions carefully enough to open it. We would not have opened it otherwise, and we would close it again tomorrow if we were persuaded, on evidence, that we had answered any of them wrong.”

— Dr. Alastair R. Vellacott, Managing Partner

The eligibility framework

Prospective clients of the Genetic Select™ line are received in the ordinary intake channel of the corporation's Office of Client Services, and, having been received, must satisfy the following conditions in full before an appointment on either arm of the line can be offered. The list is not the whole of the intake criterion; it is the portion of the criterion that the corporation is prepared to publish. The remainder is embodied in the Clinical Review Board's standard operating procedures for the line, is reviewed by the Independent Ethics Board at each of its quarterly meetings, and is not disclosed at the level of the individual case.

• Two adult prospective parents in full civil capacity. The line is offered only to a pair of adult prospective parents both of whom are, at the time of intake and throughout the course of care, of full ordinary civil capacity for the purposes of the law of each of their home jurisdictions. The corporation does not offer the line to a single prospective parent, to a party under any form of guardianship, or to a party whose participation has been sought or arranged by any third person other than the party's chosen ART clinician.
• A marriage or registered civil partnership. Both arms of the line are offered only to prospective parents who are, at the time of intake, married to one another or in a registered civil partnership recognised by the law of at least one of their home jurisdictions. The corporation does not, as a matter of standing practice, admit prospective parents whose union is not so recognised, whatever the reason for the non-recognition, and does not propose to be drawn into a case-by-case appraisal of the circumstances.
• A treating ART clinic already engaged. The second arm of the line is offered only to prospective parents who have, at the time of intake, an established and continuing course of care with an assisted-reproductive-technology partner clinic in a jurisdiction where every step of that clinic's ordinary IVF workflow — ovarian stimulation, gamete collection, in-vitro fertilisation, embryo cryopreservation, embryo transfer, and the disposition of embryos not transferred — is lawful for the prospective parents in question. The corporation will not itself introduce a client to an ART clinic and does not endorse or accredit any such clinic. The corporation will decline a case referred by a partner clinic in which the corporation cannot satisfy itself that the partner clinic is in ordinary regulatory standing at home.
• A course of independent counselling. Both prospective parents must have completed, before the writing of the diagnostic report, a course of genetic and psychological counselling with a counsellor of the prospective parents' own choosing, independent of the corporation and unaffiliated with either the treating ART clinic or the corporation's own clinical staff. A copy of the counsellor's written attestation of completion is required at the point of report release.
• Jurisdictional lawfulness at every step. Neither arm of the line will be offered where any step of the workflow — including carrier screening, in-vitro fertilisation, preimplantation diagnosis, embryo selection, embryo transfer, embryo cryopreservation, or the disposition of embryos not transferred — is unlawful for the prospective parents in question in either of their home jurisdictions. The corporation does not accept referrals under medical-tourism arrangements from prospective parents whose home jurisdiction disallows any step of the workflow. The jurisdictional matrix published today reflects the position at opening; it will be reviewed at each quarterly meeting of the Independent Ethics Board.
• No selection on sex except on stated medical grounds. The corporation will report the sex of each screened embryo to the treating clinic but will not permit an election on that sex except where the election is made on the stated medical ground of avoidance of a sex-linked heritable condition demonstrable in the prospective parents' own screen. An election on any other ground will be declined at the report stage and the case closed.
• No selection against a condition the Board has excluded. The corporation will not accept an election against any condition the Independent Ethics Board has, on the standing recommendation of the Scientific Advisory Board and on submissions received from patient-advocate groups, chosen to exclude from the corporation's selection panel. The current exclusion schedule is published in the corporation's standing disclosures and will be revised on the Board's own initiative from time to time.
• No selection for a purpose the corporation has itself declined. The corporation reserves the right, and at intake will exercise the right, to decline any election which the corporation has come to the view is not a proper election for the corporation to be the instrument of. Such a declination is not appealable, is not open to reconsideration on a second application by the same prospective parents, and is not disclosed to any third party save at the prospective parents' own written request.

Prospective parents who satisfy each of the conditions above are invited to submit a written intake application to the Office of Client Services, upon which the intake will be reviewed under the Clinical Review Board's standard operating procedures for the line. The prospective parents will be advised, within twenty-eight days of the receipt of a complete application, whether the case has been accepted, has been referred back for further particulars, or has been declined. A declined intake is confidential to the corporation and to the prospective parents; no notice of declination will be provided to any third party, including a referring ART clinic, save at the prospective parents' own request.

Oversight of the line

The internal Clinical Review Board, which developed the line over the four years preceding the present opening, retains protocol authority over the individual case. The Independent Ethics Board, constituted in June of the present year on the recommendation of the Scientific Advisory Board and chaired for its first term by a senior member of the Karolinska Institute, retains procedure-class authority over the line as a whole, including the standing power to suspend the line in whole or in part by two-thirds vote pending investigation. The exclusion schedule referenced in the eligibility framework above is the responsibility of the Board and of the Board alone; neither the Clinical Review Board nor the corporation's Managing Partner has authority to shorten it.

Genetic Select™ is the first of the corporation's four service lines to have been authorised, from the outset of its commercial operation, under the standing oversight of the Independent Ethics Board. The other three lines — Genetic Maintain™, Phenotype Renovations™, and Genotype Renovations™ — have been the subject of a retrospective procedure-class ratification by the Board, in the ordinary form of a first-quarter authorisation extended to a line already in commercial operation. The safety registers for those three lines are unaffected by the ratification and remain measured from their respective service-opening dates.

“The Board's authorisation of a procedure class is not a warranty on the science and it is not a permission to proceed on the individual case. It is a judgment, on the evidence before the Board at the moment it is asked, that the shape of what is proposed is a shape the corporation may be trusted to offer. The Board has judged that Genetic Select is such a shape. The Board has judged so on the framework the corporation has put in front of it, and on no other. Should the framework be materially altered without a fresh submission to the Board, the authorisation lapses.”

— Statement of the Chair of the Independent Ethics Board, released with the authorisation

Availability at opening

Consultation on the first arm of the line is offered from today at the corporation's Ulaanbaatar campus, in the ordinary intake languages of the Office of Client Services (Mongolian, Russian, English, French, and German). The second arm of the line will accept its first embryos for diagnosis from the first of December 2014, by which date the corporation's diagnostic laboratory will have completed the validation programme currently in progress and will have concluded the technical-and-legal accreditation exchange with the small initial list of partner ART clinics with which the corporation has, over the past twelve months, corresponded. The corporation does not propose to publish that list of clinics; a prospective client's treating ART clinic may enquire, on the client's own written authority, whether the clinic in question is on the current list.

The line will not be offered, at opening, to prospective parents resident in the United Kingdom, in the United States of America, in the Federal Republic of Germany, in the Italian Republic, in the Federative Republic of Brazil, or in the People's Republic of China, in each case for reasons of jurisdictional lawfulness at one or more steps of the workflow set out above. Prospective parents resident in those jurisdictions who wish to be notified of any future change in the position may write to the Office of Client Services; the corporation does not undertake to advise on their local law and asks that its silence on that head be respected. The jurisdictional matrix will be revised at each quarterly meeting of the Independent Ethics Board and republished as revised.

What Genetic Select is not

Genetic Select™ is not an assisted-reproductive-technology service. Furnetics does not offer in-vitro fertilisation, embryo transfer, gamete donation, gestational surrogacy, or the medical management of a pregnancy. Prospective clients who have not already engaged an ART clinic on their own initiative are respectfully referred to their local health system and are not otherwise counselled by the corporation on the choice of a clinic.

Genetic Select™ is not a genetic modification service. It performs no editing of any genetic sequence and no intervention at the germline. Where a prospective parent's course of enquiry is properly one of heritable germline modification rather than of selection among naturally-arising embryos, the correct service line is Genotype Renovations™, which is offered on separate terms, and to which the prospective parents may be referred at intake at their own written request.

Genetic Select™ is not a paediatric service. The corporation performs no clinical procedure on a child conceived through the line, does not itself confirm the outcome of a birth to the treating ART clinic, and does not solicit or accept any post-birth report from the prospective parents. The mandatory structured follow-up which applies to every other Furnetics client under the corporation's post-market surveillance framework applies here only to the two prospective parents and only in respect of the diagnostic and counselling steps of the line; the corporation records no follow-up datum on any conceived child, holds no register of such children, and does not propose to alter that position at any future date.

Enquiries

Enquiries from prospective clients may be directed to the Office of Client Services, 15 Sükhbaatar Square, Ulaanbaatar, in any of the intake languages set out above. Enquiries from ART partner clinics may be directed to the Office of the General Counsel at the same address. Enquiries from the medical or general press are received at the same address and will be answered where the answer is both possible and proper; the corporation asks in advance for the patience of any enquirer whose particular question concerns a matter the corporation has, by the framework above, chosen not to discuss.

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