NEW YORK (GenomeWeb) — Self-collected gynecological samples are becoming the standard of care in other parts of the world, but the method has yet to gain traction in the US. A newly launched test from uBiome hopes to change that while helping more women be in line with guidance for cervical cancer screening and annual well woman exams.
The test, called SmartJane, is a sequencing-based lab-developed test for 14 high-risk strains of human papillomavirus, five low-risk HPV strains, and four common sexually transmitted diseases — chlamydia, gonorrhea, syphilis, and Mycoplasma genitalium. SmartJane also contains the world's first vaginal microbiome test, said uBiome Cofounder and CEO Jessica Richman.
The test uses vaginal self-sampling as the sample collection method. A growing body of research has demonstrated patient-collected vaginal samples have comparable results to clinician-collected cervical samples, including an evaluation last year using the Cepheid GeneXpert HPV test in Papua New Guinea, for example, and a study in Scotland using Roche's Cobas 4800 HPV assay.
Internationally, self-sampling is becoming a more common way to get screening to women who are reluctant to visit a doctor. It is also increasingly being used or considered as a primary screening tool for all women. The Netherlands has begun offering self-collection for HPV screening using the Roche Cobas HPV test to replace Pap smear testing as the primary screening test in its national cervical cancer screening program, and a number of other countries, including Norway, Finland, and Australia have also begun seriously exploring self-collection, Richman noted.
The test is not meant to replace an annual exam, Richman asserted, but it is hoped it might reach the one in five women who, for whatever reasons, choose to avoid going to the gynecologist for an exam.
SmartJane is the third test from uBiome. The first test, called Explorer, was designed for people to learn about lifestyle and food and how the microbiome is affected by diet, but it is not a medical test, Richman said.
In late 2016 the firm then launched SmartGut, "the first sequencing-based clinical microbiome test," Richman said. It’s an LDT, processed in the firm's CAP-accredited and CLIA-certified lab in San Francisco and meant for patients with chronic gut issues like inflammatory bowel disease and "leaky gut" that need to monitor their symptoms with their doctor and potentially guide treatment.
The SmartJane test builds on the firm's technology and experience with its initial tests. The leap from gut to vaginal microbiome was also inspired by a general lack of biotech innovation being applied to women's health.
The test will require a physician to order, Richman said, and the firm is reaching out to physicians through marketing. uBiome is also planning to communicate to patients, who can then contact the company for referral.
"We have an external clinical care network that we work with that can find them a doctor if they're new in town and don't have a regular doctor, or don't want to go to their doctor for whatever reason — we can find a doctor that can prescribe the test and they can visit afterwards," she said.
The firm will also offer interpretation support, and has physicians on staff for that purpose. Interpreting the HPV and STD results is pretty straightforward. The firm is also providing microbiome counseling, to tell physicians what a dysbiosis might mean.
A balanced vaginal microbiome is quite simple. "The vaginal microbiome likes to be a monoculture; it should be mostly lactobacillus," Richman said. While there are tests for pathogens of the vaginal ecosystem, there aren’t any that measure the different organisms that can disrupt the balance of the vaginal microbiome and make it less of a monoculture of lactobacillus, and creates different risks.
"For HPV and STDs [physicians] are going to be trained to understand well woman exams and how to treat, so we're kind of replicating the standard of care for people to do at-home testing," Richman said. Interpreting results of the vaginal flora is quite novel, but the firm also has guidelines and training that it gives physicians about what to recommend if the lactobacillus count is lower than it should be.
The SmartJane microbiome testing may prove useful in recurrent vaginosis and vaginitis, where it can be difficult to determine the root cause and where they may in fact be multiple things leading to recurrence, Richman said. A microbiome assessment could also tell patients and physicians whether any treatment attempts are working.
The potential market size for the test is a little challenging to ascertain. "We think it is a very big market because it is the market of HPV screening combined with STI screening, plus the unknown size of the market of women who need clinical vaginal microbiome tests," Richman said. The latter would be mostly women who have imbalances of the microbiome, and there is currently no comparable testing available.
For now, the SmartJane test is available through uBiome's pilot program. The firm is billing insurance using a number of different codes, so it is not possible to say exactly what the cost is at this time, but patients won't be billed for the test during the initial pilot period, which could last around one year.