Recently, there was a buzz in the pregnancy testing world because a company called Lia Diagnostics received pre-market approval from the FDA for the first biodegradable pregnancy test that can be flushed down the toilet. When I excitedly emailed my co-blogger David about this, he said “Is that something that is really important to women?” This is a good question. Today I’d like to discuss why I think this type of product is important and take a look at the 510(K) premarket notification which is publicly available.

First, why is a flushable home pregnancy test important? One of the things that initially made home pregnancy devices attractive when they were first marketed back in the 1970’s is privacy.  They can be used in your own home. No need to go to a doctor or health center to find out if you are pregnant. You are the first to know in the privacy of your own home. However for some women, achieving privacy, even where they live, is difficult. Being able to flush the device down the toilet allows women to truly achieve privacy. No one will know the results or that the testing was even done.

The other reason that a flushable pregnancy device is important is environmental. Pregnancy devices are made from plastic and end up in land-fills. This is a huge burden on our environment and can no longer be ignored in the US or in developing countries, where these devices are also used. Imagine the environmental impact this device could have if it set a trend for other home pregnancy devices and other biomedical products to become biodegradable.  I feel that for this reason alone, this is a major milestone.

One thing that was not talked about in the press (and I could not find on the Lia website) is whether the packaging is also biodegradable & flushable. This will be key to achieve true privacy & environmental friendliness. In my laboratory, we do studies on pregnancy devices. Here I have included some photos of the trash we generated from just one study. As you can see, a great deal of that trash is packing material. This needs to be flushable and biodegradable too in order to achieve the company’s goals of privacy & environmental friendliness.

Trash generated from one of our home pregnancy device studies (property of Ann M. Gronowski)

Next, let’s take a look at the 510(K) pre-market notification for the Lia Pregnancy test. Lia compared their device to the OSOM hCG urine test. Our lab has studied the OSOM device in the past. In the summary document they show that the device can detect 100% of samples with an hCG concentration of 22 IU/L and 50% of samples at 14 IU/L. This is similar to other over-the counter devices on the market. Using 153 urine samples, the Lia device showed 100% concordance with the OSOM device. The device showed no cross reactivity with LH up to 500 IU/L and FSH & TSH up to 1000 IU/L. They evaluated the hook effect (something that can cause a false-negative result) up to 500 IU/mL (500,000 IU/L) which is good. They also checked for a hook due to hCG β-core fragment and showed no effect up to 500,000 pmol/L, which is a concentration at which we have previously demonstrated the OSOM device to give false negative results.

The Lia pregnancy test is scheduled to be available for purchase in mid-2018. Based on the data submitted to the FDA it sounds very promising. I hope that this novel product will induce other medical device companies take note and start to manufacture more biodegradable products.

Originally published by The Pregnancy Lab

 

 

About The Author

Professor of Pathology & Immunology, and Obstetrics & Gynecology, Washington University School of Medicine

Dr. Gronowski is a Professor of Pathology & Immunology, and Obstetrics & Gynecology at Washington University School of Medicine (St. Louis Missouri). She is Associate Medical Director of the Clinical Chemistry and Serology & Immunology laboratories at Barnes-Jewish Hospital. Dr. Gronowski received her Ph.D. in Endocrinology- Reproductive Physiology from University of Wisconsin, and is a diplomate of the American Board of Clinical Chemistry. Dr. Gronowski is past president of the American Board of Clinical Chemistry and the American Association for Clinical Chemistry. Her research focuses primarily on the laboratory diagnostics of endocrinology and reproductive physiology with a particular emphasis on maternal fetal medicine. She edited the book entitled “Handbook of Clinical Laboratory Testing During Pregnancy”.