The Food and Drug Administration has cleared a NYU Langone Health next-generation sequencing test that guides treatment decisions for cancer patients. Cleared under a 510(k) designation, the NYU Langone Genome Profiling of Actionable Cancer Targets (PACT) test detects variations in 607 genes associated with various cancers. At this time, the test is cleared for use only in NYU Langone Health patients.
The PACT test is designed for integration into electronic records. Its development included a collaboration with the healthcare technology company Phillips on genomic processing and interpretation. The collaboration produced an interface between the new test and NYU Langone Health’s electronic medical records system.
The PACT assay includes genes with established roles in cancers and with relationships to targets of currently approved cancer drugs. The assay also
includes genes related to currently studied compounds or strongly linked to cancers in basic science studies, with an eye toward genetic variants that may be important in diagnosis and treatment of cancer over the next 5 to 10 years.
PACT is designed to be part of ongoing efforts by the NYU Langone research community to find previously unknown changes in genes that further improve diagnoses or yield new pathways to target with drugs.
AMAZON COVID-19 KIT GETS EUA
The Amazon COVID-19 Test Collection Kit DTC has received emergency use authorization (EUA) from the Food and Drug Administration. The direct-to-consumer kit enables self-collection of nasal samples, which users send via pre-paid UPS next-day shipping to Amazon’s Hebron, Kentucky diagnostics laboratory for polymerase chain reaction testing. Customers will receive test results within 24 hours of their sample’s arrival at the lab, and results are available through Amazon's secure website AmazonDx.com.
The collection kit is for use by individuals ages 18 and older and requires registering the collection kit via a U.S. mobile phone with text messaging.
FDA GRANTS EUA FOR THERMO FISHER SCIENTIFIC NEXT-GENERATION COVID-19 ASSAYS
The Food and Drug Administration has granted an EUA for the TaqPath COVID-19 Fast PCR Combo Kit 2.0 and the TaqPath COVID-19 RNase P Combo Kit 2.0, both marketed by Thermo Fisher Scientific. The tests are designed with increased target redundancy to compensate for current and emerging SARS-CoV-2 variants. The two tests leverage an updated design from the original TaqPath assays, targeting eight different genes across three regions of the virus that causes COVID-19.
The TaqPath COVID-19 Fast PCR Combo Kit 2.0 assesses raw saliva. Results are returned in about 2 hours to enable broad, high-frequency testing.
The TaqPath COVID-19 RNase P Combo Kit 2.0 is designed with an approximate 3-hour turnaround time and can detect SARS-CoV-2 from individuals suspected of COVID-19 by their healthcare provider, as well as from patients who are asymptomatic.
PILLAR BIOSCIENCES RECEIVES FDA PMA FOR LUNG AND COLON CANCER ASSAY
The Food and Drug Administration (FDA) has granted premarket approval (PMA) for the oncoReveal Dx Lung and Colon Cancer assay, marketed by Pillar Biosciences. The assay is a next-generation sequencing, tissue-based companion diagnostic test for the qualitative detection of somatic mutations in DNA derived from non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) tumors.
The PMA covers the test as a companion diagnostic for all FDA-approved epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapies for NSCLC targeting exon 19 in frame deletions and exon 21 L858R substitution mutations in EGFR. The PMA also allows use as a companion diagnostic for KRAS wild-type tumor tissue with absence of mutations in codons 12 and 13 for metastatic CRC patients, when targeted treatment with Erbitux (cetuximab) or Vectibix (panitumumab) is warranted.
This panel assay is intended to be used on the Illumina MiSeq Dx instrument.
SPEEDX RECEIVES CLEARANCE IN AUSTRALIA FOR COVID-19 DIAGNOSTIC TEST
The SpeeDx PlexPCR SARS-CoV-2 test has received clearance from the Australian Therapeutic Goods Administration. The two-gene, single-well test detects all known current circulating variants of SARS-CoV-2. The test offers scalable 96- or 384-well capacity, automated software reporting, and liquid handling robotics in the form of the SpeeDx PlexPrep. The combination of PlexPrep robotics and automated software analysis can support a scalable workflow for throughputs of 480 to 1,920 patient samples in an 8-hour shift.
ONCOTYPE DX BREAST RECURRENCE SCORE PROGRAM APPROVED IN JAPAN
Japan's Ministry of Health, Labor, and Welfare (MHLW) has approved the Oncotype DX Breast Recurrence Score Program. It helps guide chemotherapy treatment recommendations and provides risk of distant recurrence in patients with hormone receptor-positive, HER2-negative early-stage breast cancer with up to three positive lymph nodes. The approval is a critical step in making Oncotype DX, marketed by Exact Sciences, accessible to breast cancer patients in Japan.
The Oncotype DX Breast Recurrence Score Program approved in Japan combines the Oncotype DX Breast Recurrence Score test and software developed for the Japanese market. Exact Sciences plans to pursue coverage under Japan's universal healthcare insurance system and launch the test through its Japanese affiliate, Exact Sciences K.K.
According to Exact Sciences, Oncotype DX is the only test validated to determine which patients will benefit from chemotherapy and provides critical information beyond traditional prognostic factors. The test is supported by prospective outcomes data that show most patients with either node-negative or node-positive disease can be spared chemotherapy when decisions are guided by Oncotype DX.
TWO NEXT-GENERATION HIV-1 TESTS GET CE-IVD CLEARANCE
CE-IVD clearance has been granted to two next-generation extended-coverage (XC) tests for HIV testing marketed by Cepheid. Xpert HIV-1 Viral Load XC is intended to assess viral load levels, which are used to monitor effectiveness of antiretroviral treatment. It provides extended strain coverage to improve performance and address the risk of false negative results due to gene mutations or deletions. Xpert HIV-1 Qual XC has also been cleared for use. The test facilitates dried blood spot sample processing and a simplified workflow. Both tests are designed for use on any of Cepheid's GeneXpert Systems.