Monash IVF aware faulty test may be destroying healthy embryos months before stopping

Monash IVF was aware a faulty test may be causing it to needlessly destroy healthy embryos three months before it suspended the procedure.

Secret documents released by the TGA have raised questions about the conduct of Monash IVF. Picture: Istock

Monash IVF continued to promote and use a test despite knowing for months it was faulty and could result in healthy embryos of women desperate to have children being needlessly destroyed, the Herald Sun can reveal.

Secret documents released by the TGA have raised questions into the conduct of the IFV giant, which was forced to abandon its touted world first genetic testing program over fears healthy embryos were being destroyed.

Correspondence between Monash IVF and health authorities also raises concerns that the data used to gain approval for the test may have been manipulated to indicate the test was more accurate than it was.

Confidential disclosures from Monash IVF’s genetics laboratory at Repromed reveal clinical trial samples that would have lowered the niPGT-A test’s accuracy rate “may have been deliberately omitted from the validation summary table” before it was submitted to the medical licensing authority.

Other samples which improved the accuracy rate were found to be “duplicates” or “triplicates”, with the multiple counting of positive tests inflating its level of success.

Angela and Phil Ceberano were caught up in the saga. Picture: David Caird

Using the data to gain ­approval from the National Association of Testing Laboratories, Monash IVF then rolled out its non-invasive PGT-A test across the country from May 2019.

Up to 1300 women used the test while trying to find out if their embryos were viable for IVF procedures before the Herald Sun exposed doubts on its accuracy in October 2020, sparking a series of investigations that saw it scrapped.

However, documents released by the TGA under Freedom of Information reveal Monash IVF was aware of “significant” issues with its test as early as June 2020, but continued offering it to desperate clients until September 25, 2020.

Margalit Injury Lawyers managing principal Michel Margalit – who is representing Monash IVF clients in a major class action – said hundreds of patients could have been spared grief if the test was abandoned as soon as doctors knew it was faulty.

“I think it’s appalling that they kept going,” Ms Margalit said. She said the documents reveal the clinical trial data used to gain approval for the test was “a complete shambles”. In a letter to TGA investigators in October 2020, Monash IVF’s laboratory at Repromed confirmed it reviewed the niPGT-A test in June 2020 and found it was significantly less accurate than accepted tests.Despite finding fault with the test, neither Monash IVF or Repromed alerted medical authorities, with internal TGA documents confirming the watchdog only became aware due to the Herald Sun’s investigation on October 14.

In 2020 Angela Ceberano was told by Monash IVF her embryos were not viable and had been discarded, only to later discover they had actually been kept in storage for months.

After being told on Wednesday that the clinic continued using the genetic screening test for months while knowing it was faulty, Ms Cebarano demanded authorities take further action.

“It makes me feel sick to the stomach and it’s absolutely appalling,” Ms Cebarano said.

“This is people’s lives they are talking about.

“They are more worried about their shareholders and making profits than the patients they are meant to care for.”

In a statement Monash IVF said it became aware of an “unexpected trend in the outcome of IVF cycles” through routine monitoring of outcomes in June 2020. “Monash IVF promptly suspended the screening process following initial outcomes of this preliminary investigation.“Throughout this time, Monash IVF have acted in the best interests of its patients and have ensured that all decisions were supported and made in a prompt manner.”

Originally published as Monash IVF aware faulty test may be destroying healthy embryos months before stopping