Elucigene has been developing in vitro diagnostics for oncology and reproductive health, including tests for cystic fibrosis screening and prenatal fetal aneuploidy screening.
The new assay is part of the company's prenatal and women's health offerings, but it is also developing a preeclampsia test and technology for gastrointestinal testing.
The Austin, Texas-based company offers more than 30 tests, including those for food sensitivity, fertility and women's hormones, sexually transmitted diseases, and thyroid.
The company said its higher revenues were due in part to international performance including continued penetration of Middle Eastern and Asian markets.
A study of 10 commercial labs offering NIPT in the US found that none followed all recommendations for reporting results and informing patients and providers.
The addition of the Y chromosome detection will enable the firm to refine its already-approved MaternalFetalScreen T1 test to provide personalized risk assessment.
Under a proposed decision, to be finalized in August and become effective in late 2020, NIPT would only be covered for women with particular fetal trisomy risks.
The company will launch a clinical version of its liquid biopsy assay in the second quarter and plans to launch clinical trials that make the case for reimbursement.
Using BGI's sequencing technology, the firms plan to commercialize Natera's Signatera test in China and to develop reproductive health tests in "select markets."
The firm has launched a 2,300-subject prospective study evaluating the test, which measures exosome proteins to assess a woman's risk of preterm delivery.
The team found that patients with a threshold of 100 micromoles of bile acid per liter were as much as twice as likely to have stillbirths as other groups.
