NEW YORK (GenomeWeb) – CombiMatrix this week introduced CombiPGS, a new preimplantantion genetic screening test for women undergoing in vitro fertilization.
Run using bacterial artificial chromosome arrays from within its Irvine, Calif.-based services laboratory, CombiPGS allows CombiMatrix to enter a "lucrative, cash-pay market," CEO Mark McDonough said in a statement.
The IVF market has attracted the interest of a number of companies in the life sciences and molecular diagnostics arenas. Illumina in 2012 paid $88 million to acquire Cambridge, UK-based BlueGnome, a supplier of microarray-based tests for both preimplantation genetic screening and preimplantation genetic diagnosis. Illumina earlier this year also debuted VeriSeq, a next-generation sequencing-based PGS assay for use on its NextSeq 500 and MiSeq systems.
Two other players in the nascent PGS space include Oxford Gene Technology and Reproductive Health Science. Oxford, UK-based OGT has introduced several arrays for PGS. RHS, an Adelaide, Australia-based biotechnology company, has similarly developed an array-based tool for PGS.
For CombiMatrix, the IVF market is a "natural extension" of its current offering, allowing the firm to provide a "continuum of care, from pre-implantation genetic screening, miscarriage analysis, [and] prenatal diagnosis [to] testing for pediatric developmental disorders," McDonough told GenomeWeb in an email.
"The market is burgeoning – it's a $30 million annual market and growing," McDonough said. "We are [also] able to capitalize on our microarray experience of running more than 28,000 tests since 2006," he noted.
Since CombiMatrix began offering pediatric chromosomal microarray analysis eight years ago, it has expanded its menu to include array-based tests for miscarriage analysis and prenatal diagnosis. Because of this, McDonough called the firm's new CombiPGS offering a "natural extension to our existing market" that allows the company to provide its clients with a "continuum of care."
CombiMatrix employs Illumina SNP arrays in its miscarriage analysis, prenatal, and pediatric testing services, and it has opted to stick with the same vendor by using BlueGnome BAC chips as part of CombiPGS. BlueGnome's 24sure PGS chips are designed for the screening of all 24 chromosomes to enable selection of embryos for transfer as part of an IVF cycle. Each array contains 3,000 BAC clones, and data analysis is carried out using BlueGnome's BlueFuse Multi software.
As such, CombiMatrix is "employing the BlueGnome arrays as a service provider, and will leverage its channel in IVF clinics to sell multiple products," said McDonough. He added that CombiMatrix can provide a 24-hour sample turnaround time, depending on the clinical situation, and that the company is offering CombiPGS through its existing commercial infrastructure nationwide.
CombiMatrix already has a client base of IVF clinics because of its test for miscarriage analysis, which is marketed as the CombiSNP Array for Pregnancy Loss. The assay has in recent years become CombiMatrix's "fasting-growing product," McDonough noted.
"The IVF clinic is now a primary call point for us for miscarriage analysis testing performed on fresh tissue and [formalin-fixed, paraffin-embedded] samples, PGS testing on embryos, and parental karyotyping," said McDonough.
Because the new CombiPGS service is such a "great fit" for CombiMatrix, the company expects the offering's introduction could have an impact on revenues in coming quarters. "We believe this will have a positive effect on pull-through testing for our recurrent pregnancy loss test as we also make an impact on the burgeoning PGS market," McDonough said, though he didn't elaborate.
CombiMatrix's CombiPGS service allows couples to screen embryos for chromosomal abnormalities prior to implantation of the embryo in order to maximize the chance of successful implantation and pregnancy progression and to decrease the likelihood of a miscarriage.
The company said in a statement that it will begin accepting embryo samples, for fresh and frozen transfer, beginning Dec. 1. When asked if CombiMatrix was mulling any additional offerings in the IVF space, McDonough said that the company will evaluate any further opportunities as they arise.