The cervical cancer screening test GynTect is now available to physicians and patients in China. Developed by the German company oncgnostics, it is the first methylation assay for triage of human papillomavirus (HPV)-positive cases that the Chinese National Medical Products Administration has approved. GynTect received this approval after a large-scale, multiyear study involving approximately 10,000 participants that demonstrated the test’s efficacy.

GynTect clarifies early on whether a patient with an abnormal finding on cervical cancer screening has a predisposition for or already has cervical carcinoma and needs prompt treatment. The screening test detects epigenetic changes and requires a sample from a cervical smear—the same sample type typically obtained for thin-layer cytology or HPV testing.

China has approved GynTect for use in women 30 years and older who are infected with high-risk, cancer-causing HPV types. Studies have shown that approximately 17% of women, or about 70 million female patients in China, are infected with one of these types of high-risk HPV and need screening. However, only a few women with an HPV infection will develop cervical cancer. These are the cases that the Gyntech test is designed to detect.

GynTect is distributed in China by GyneoDx under exclusive license. In addition to China and numerous European Union countries, GynTect is also marketed in Brazil and Mexico.

Thermo Fisher Scientific Gets CE Mark for Cancer Sequencing Test and Analysis Software

Thermo Fisher Scientific has received the CE mark for a next-generation test, genomic reporting software, and sequencer to speed tumor molecular profiling. Altogether, the Oncomine Dx Express test, Oncomine Reporter Dx, and lon Torrent Genexus Dx Integrated Sequencer offer an automated end-to-end workflow. Operated from a single software interface, the process requires less than 20 minutes of under time and delivers results in less than 24 hours.

The Oncomine Dx Express test is qualitative and detects deletions, insertions, substitutions, and copy number gain present in 42 genes, as well as fusions or splicing variants in 18 genes from DNA and RNA in formalin-fixed paraffin-embedded tumor tissue samples of solid malignant neoplasms. Additionally, the assay detects deletions, insertions, substitutions in 42 genes, and fusions or splicing variants in seven genes from cell-free DNA extracted from plasma samples of non-small cell lung cancer.

Helix Diagnostics’ Multiplexed SARS-CoV-2 Assay Earns FDA EUA

The Food and Drug Administration has granted emergency use authorization (EUA) to Helix Diagnostics’ SARS nCoV-19 multiplexed assay. The test is authorized for qualitative detection of SARS-CoV-2 RNA in human anterior nasal swab samples collected from individuals who have symptoms of COVID-19. The test can also be used with individuals without symptoms when the individuals are tested at least once per week using test procedures validated in accordance with the requirements of the Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing.

In the case of serial testing, additional confirmatory testing for negative results may be necessary if there is a high likelihood the individual has COVID-19—e.g., because the individual had suspected exposure to SARS-CoV-2. Additional confirmatory testing for positive results may also be necessary if there is a low likelihood of COVID-19, such as in individuals without known exposure to the virus or who reside in communities with low prevalence of infection.

Myriad Genetics’ BRACAnalysis Diagnostic System Gains Japanese Approval as Companion Diagnostic

Japan’s Ministry of Health, Labour, and Welfare has granted expanded coverage for use of Myriad Genetics’ BRACAnalysis Diagnostic System as a companion diagnostic to identify patients with germline BRCA-mutated and HER2-negative high-risk recurrent breast cancer who may benefit from Lynparza (olaparib).

The BRACAnalysis Diagnostic System is designed to detect and interpret germline BRCA1 and BRCA2 variants, including deleterious or suspected deleterious variants in patients with HER2-negative high-risk early breast cancer. In the OlympiA trial, Lynparza demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival, reducing the risk of invasive breast cancer recurrences, new cancers, or death.

With this expanded coverage, more patients with breast cancer now qualify for BRCA1/2 testing in Japan, Myriad officials said.

CE Mark Granted to SkylineDx Skin Cancer Test

SkylineDx has received the CE mark for the Merlin Assay, which identifies melanoma patients who have low risk for nodal metastasis and who can forgo invasive sentinel lymph node biopsy surgery, a procedure that is used to determine metastatic spread of cancer for staging purposes. Based on quantitative PCR, the Merlin Assay uses a proprietary algorithm that calculates the risk of metastasis in a patient’s sentinel lymph nodes. This model can calculate risk on an individual basis through a combination analysis of eight genes from the patient’s primary tumor, the tumor thickness, and the patient’s age.

Additionally, the company noted that Medicare recently began covering the Merlin Assay’s U.S. counterpart.

Colon Cancer Assay Gets Chinese Approval

China’s National Medical Products Administration (NMPA) has approved Pillar Biosciences’ oncoReveal Dx Colon Cancer Assay. With this approval, the test is now available in China, the U.S., and Europe as a companion diagnostic. It is intended to identify patients with colorectal cancer whose tumors express wild-type KRAS status and who may also benefit from treatment with specific targeted therapies, including Erbitux (cetuximab) or Vectibix (panitumumab). The assay utilizes Pillar’s SLIMamp next-generation sequencing technology.

OncoReveal Dx Colon Cancer Assay is Pillar’s first NMPA-approved diagnostic product. Pillar’s oncoReveal Dx Lung & Colon Cancer Assay previously received CE-IVD certification in Europe in April 2020 and Food and Drug Administration premarket approval in July 2021.