Applications

By integrating traditional real-time PCR technologies with innovative engineering concepts, the PeakV™ sample-to-answer POCT/POAT system delivers rapid, high-precision results with minimal hands-on steps. PeakV can complete a 40-cycle PCR reaction and signal detection in as little as 5 minutes while maintaining accuracy, sensitivity, and dynamic range from TaqMan™ assays. Users can load sample tubes directly for testing without consulting a manual, and the sample-to-answer turnaround time is under 30 minutes. Accessible to anyone, anywhere, anytime, this high-performance, user-friendly system offers reference lab quality tests and affordable superfast PCR reagents and consumables. PeakV serves as an open platform for academic, industrial, and clinical users to develop superfast real-time PCR POCT/POAT applications in various fields.

PeakV can provide unique solutions in two significant areas:

Test labs with their own LDTs or third-party test kits may want to improve their services by offering POC test services. Currently, all existing sample-to-answer instruments use closed-cartridges. The market lacks an open sample-to-answer instrument due to the absence of open cartridge technology. Labs would benefit greatly from a "do-it-yourself" open instrument for assay development or assay transfer. PeakV fills this gap, offering an open assay platform for sample-to-answer testing.
Test labs that do not have their own LDTs but wish to develop and sell unique assays not available from existing sample-to-answer instrument manufacturers could greatly benefit from an open assay platform. Ideally, these labs would use an instrument that automates manual lab steps, allowing for easy transfer of developed test kits. PeakV offers this solution, providing a seamless, automated process.

PeakV is an open platform and allows a large number of individual test labs to build their sample-to-answer cartridges without much difficulty. Star Array is seeking collaborations for the following applications and beyond.

Infectious Disease Testing:

Respiratory panels - PeakV offers flexibility in testing single targets, small panels, or large syndromic tests of up to 64 pathogen targets. The system can conduct pre-amplification before panel testing, process swabs and sputum samples, and integrate bead beating into the user protocol without manual liquid handling to minimize contamination risk.

UTI Panels - Users can insert capped urine sample bottles directly into the PeakV instrument, eliminating manual handling and reducing contamination risk.

Blood Panels - PeakV accepts capped bottles of whole blood, plasma, or blood culture medium (up to 5 mL), avoiding manual handling and minimizing contamination risk. Applications include HIV, HBV, HCV, sepsis panels, and Zika and dengue viruses.

GI panels - PeakV allows for single target testing, small panel testing, and large syndromic testing of up to 64 pathogen targets.

STI panels - The system can test multiple STI pathogens in small or medium-sized PCR panels.

Women's Health Panels - PeakV is capable of testing large panels for HPV and STI genotypes.

Feces Panels - The system can directly process sample tubes containing raw fecal samples, integrating centrifugation for extraction and purification, followed by single target or panel testing.

Cancer Testing:

Liquid Biopsy Test - PeakV can process up to 5 mL of whole blood or plasma samples and PCR panel sizes ranging from 1 to 64 targets. The system is capable of sophisticated novel MS-nested PCR for ultra-high detection sensitivity and specificity.

Solid Tumor Test - PeakV can grind and digest solid tumor biopsy samples in its protocol and test 64 mutations, with nested PCR for ultra-high detection sensitivity and specificity.

Non-Clinical Testing Applications:

PeakV provides a fully automated open testing platform for various non-clinical test applications, including:

NGS library prep module integration
Pre-amplification and PCR genotyping panel applications
Pet disease testing
Food and beverage contamination testing
Seed, plant, and soil testing
Border control and CDC monitoring
General lab testing, using PeakV as an open platform with lab-specific reagents