NEW YORK – With the UK launch of its combination PCR and immunoassay testicular cancer test last week, EDX Medical said that its test could improve the detection of early-stage cancers in young men as well as aid the monitoring for recurrence following treatment.
According to CEO Mike Hudson, EDX Medical is refining and optimizing its test ahead of submissions for certification under the EU's In Vitro Diagnostic Regulation as well as planning for an eventual US launch. The company said that its test has high sensitivity across patient ages and ethnicities.
EDX Medical's TC100 test is used for the detection and analysis of four biomarkers, with PCR-based determination of microRNA biomarker M371 and immunoassays for the classic testicular germ cell tumor biomarkers of alpha fetoprotein, human chorionic gonadotropin, and lactate dehydrogenase. The results are analyzed with an artificial intelligence-based algorithm, and the firm generates a report on the results and the likelihood that a patient has cancer.
By enhancing the classical biomarker-based blood tests, Hudson said that the company is building on the trust that doctors have for the existing standard-of-care tests while offering additional information and improved overall accuracy.
The firm has not yet published peer-reviewed results but said that its internal data so far show that the test performs with upward of 99 percent sensitivity and 96 percent specificity for primary diagnosis, and it has performed with 100 percent sensitivity so far in the surveillance of patients following testicular cancer treatment.
The company said on Friday that the test will be available to all UK private and public sector healthcare providers within several weeks.
Although testicular cancer is uncommon overall, it’s one of the most common cancers among adolescents and young adults. It is most frequently diagnosed in men ages 20-34 years, often through physical examination, ultrasound, and serum tumor marker tests, and blood tests may be followed by surgical inguinal orchiectomy and biopsy to aid the diagnosis. Testicular cancer is typically treatable even at an advanced stage.
Hudson said that the TC100 test is particularly useful for the detection of early-stage cancers because it overcomes the low sensitivity issues of classic serum tumor biomarkers, which can achieve 50 percent to 70 percent sensitivity for stage I or II cancers. EDX has found that its test performs with greater than 90 percent sensitivity and high 80s to low 90s specificity for the detection of stage I cancers.
He noted, however, that the early detection of testicular cancer also relies in part on patients to perform regular self-examination to screen themselves for small nodules and report any discoveries to a physician. The TC100 assay is used in patients with a suspicion of cancer.
"A lot of those early cancers are missed because they're small, and yet there will be biochemical changes already detectable," he said.
Hudson said the adoption of the TC100 test also could help to reduce the frequency of testing for cancer recurrence during the years following surgical cancer removal. He noted that tests for routine blood-based biomarkers of testicular cancer are typically used along with ultrasound for the monitoring of patients for at least five years following surgery, with follow-up testing as often as quarterly in the first years followed by yearly monitoring.
When recurrence is identified early enough, treatment can be limited to surgery without the need for chemotherapy and radiotherapy, he said.
The classic biomarkers of testicular cancer have long been used to aid the diagnosis and staging of testicular cancer and the monitoring of patients for recurrence.
Various companies including Abbott, Roche, QuidelOrtho, and BioMérieux, among others, have secured US Food and Drug Administration clearances or approvals for immunoassays for the quantitative detection of individual classic biomarkers of testicular cancer. Other firms have been developing molecular alternatives that could compete in the market for genitourinary cancer testing.
In a statement, EDX spokesperson Ramsay Smith said that the test is expected to cost several hundred pounds, although final pricing has not been determined. The UK’s National Health Service has not committed to offering the test to patients, although it will be available to all public or private healthcare providers.
With the product launch in the UK, EDX is working to reach clinicians through collaborations with professional oncology, genitourinary, and urology organizations as well as through patient advocacy groups that try to raise awareness of testicular cancer and developments in its diagnosis and treatment, Hudson said.
As for the commercialization of the kitted version of the test, EDX announced in 2023 that it had inked a deal with Thermo Fisher Scientific on the joint development and commercialization of qPCR assays, and Hudson said that partners at Thermo Fisher will help EDX to develop and manufacture a standardized test kit for sale to labs in the EU and other markets. Hudson noted that the kitted version of the test likely will also become available in the UK.
The company expects that the evidence that it uses for IVDR certification and its international work with clinicians to establish the clinical utility of the test will also support adoption in the US. In the US market, the firm could form licensing or kit sales agreements with regional labs that have Clinical Laboratory Improvement Amendment certifications that are able to market laboratory-developed tests.
EDX has also in recent years formed agreements with other firms to expand its reach in cancer testing. It signed in 2024 an agreement for the distribution in the UK, Sweden, Denmark, Norway, and Finland of Caris Life Sciences’ solid tumor and liquid biopsy assays and AI-based tools, and it formed in 2023 a deal with Guardant Health to distribute in the UK, Sweden, Denmark, Norway, Finland and Iceland the Guardant360 CDx cancer genomic test as well as distribute in the UK the Guardant Reveal test for residual disease and recurrence detection in early-stage cancer.
The firm also has been building in recent years a menu of multiplex lateral flow assays for applications including sepsis risk, infectious diseases, cancer-causing viral infections, neurological diseases, and cardiovascular diseases. Using technologies gained through acquisitions, the firm has said that it planned to develop precision point-of-care multiplex tests with results in about 15 minutes.