A fertility test at home developed by a Bengaluru-based start-up has cleared a major hurdle, winning the approval of the United States Food and Drug Administration (FDA).
Inito, based in the Karnataka state capital, proclaims to “[put] a diagnostic lab in your pocket” and that it is “here to revolutionise medical diagnosis.” Addressing fertility testing is a significant part of its portfolio. The firm advertises a Fertility Monitor, which is on the verge of launching in the United States following its securing the FDA’s approval.
As a Press Trust of India report explains, “by measuring two fertility hormones in urine – Estrogen & Luteinizing Hormone (LH) along with AI [artificial intelligence] based data analytics in the App, Inito said it understands the cycle variations for every individual user, giving highly accurate results unique to every woman’s body.”
The startup, fortified by the backing of U.S.-based startup accelerator Y-Combinator, promotes its product against the backdrop of rising infertility rates in India. As reported by Health Issues India earlier this year, “according to the Indian Society of Assisted Reproduction, infertility is a rapidly increasing problem, currently affecting between ten and fourteen percent of the Indian population, with higher rates in urban areas where one out of six couples is impacted.”
A fertility test at home may be a boon for such couples. Aayush Rai, co-founder of Inito, wrote in an article for Your Story last year that “we at Inito, have also seen an increase of up to 25 percent in the number of fertility tests taken per user on our home fertility test.”
“Inito has always been committed to building a global home diagnostic testing company headquartered out of India, and this milestone takes us one step closer to that ambition,” said Rai. “The coming years will see home diagnostics become an integral part of the medical ecosystem, and we’re proud to be among the leaders of this revolution.
“Clearing the FDA regulatory pathway speaks to the commitment and dedication of our team, who have upheld the highest standards of engineering, user experience, and clinical validation throughout the course of development.”