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Following Validation Study, LifeCodexx Plans to Launch CE-marked qPCR NIPT in H2 of 2015

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NEW YORK (GenomeWeb) – German non-invasive prenatal testing provider LifeCodexx is developing a qPCR-based NIPT that promises lower cost, faster turnaround time, and easier implementation than current NIPT, which rely on next-generation sequencing or microarray analysis.

LifeCodexx CEO Michael Lutz told GenomeWeb that the Constance-based company decided to develop the test about a year ago after conducting market research. Given the widespread use of qPCR in diagnostic laboratories — Lutz said more than 50,000 qPCR instruments are installed worldwide — a qPCR test will be easier to implement in local laboratories, although LifeCodexx has not decided yet whether it will sell the test as a kit. Most laboratories offering current first trimester biochemical screening already have a qPCR machine installed, he said.

Unlike the US, where many molecular diagnostic tests, including NIPT, are run in large centralized laboratories, there is a greater need for decentralized solutions in Europe, Lutz said. UK-based Premaitha Health, for example, which recently launched a CE-marked NGS-based NIPT, already announced several deals with laboratories across Europe that will offer its Iona test.

Last week, LifeCodexx said it has completed a proof-of-principle study for the new qPCR NIPT, which it plans to launch as a CE-marked test in the second half of this year, following a blinded validation study.

For the initial study, the test identified all eight trisomy 21-positive cases out of a total of 93 well-characterized clinical samples. For the validation study that the company is currently preparing, the test will assay several hundred well-characterized samples in a blinded fashion, Lutz said.

The proprietary test methodology was developed in house at LifeCodexx, and the firm is currently not revealing its details for competitive reasons. However, Lutz said the method is different from one developed by NIPD Genetics in Cyprus, which combines enrichment of fetal methylated DNA with qPCR.

The new test will complement LifeCodexx's existing PrenaTest, which comes in three flavors. Like PrenaTest Option 1, the new test will only assess the risk for trisomy 21. PrenaTest Option 2 assays for trisomies 21, 18, and 13, and PrenaTest Option 3 assays for the three trisomies as well as sex chromosomal aneuploidies. All three options also determine the sex of the fetus. Depending on the outcome of the validation study, the test might even replace current first trimester biochemical screening, according to the company.

The price of the qPCR NIPT has not been determined yet but will cost less than NGS-based tests, Lutz said, in part because the upfront investment in a qPCR machine is significantly smaller than in NGS equipment. List prices for PrenaTest range from about €600 ($650) for Option 1 to €900 for Option 3, and an additional €100 for expedited service.

Patients currently pay for the PrenaTest out of pocket but private and statutory health insurance plans have paid for it on an individual basis. Lutz said that LifeCodexx has applied for reimbursement for PrenaTest in several unnamed European countries and expects it to be covered by statutory health insurance in Germany for high-risk pregnancies as part of a trial study later this year.

Turnaround time for the new test will likely be similar to other qPCR tests, which usually take one to two days, Lutz said. The company provides results for the PrenaTest within eight to 10 business days, or between four and six business days with expedited service, though it has returned results in as little as 2.5 days, he said.

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